BRITISH STANDARD FOR LARGE STEAM STERILIZERS

BRITISH STANDARD BS EN
.......... 285:1997
Sterilization Steam sterilizers ar!e
sterilizers
The European Standard EN 285: 1996 has the status of a British Standard
"ommittees res#onsi$le %or t&is Britis& Stan'ar'
The preparation of this British Standard was entrusted to Technical Committee B!"5# Sterili$ers# autocla%es
and disinfectors# upon which the followin& 'odies were represented:
(B)* Special *nterest Section +Sterili$ers and ,isinfectors-
(ssociation of British )ealthcare *ndustries
(ssociation of Clinical .atholo&ists
British ,ental Trade (ssociation
Central Sterilisin& Clu'
,epartment of )ealth
)ealth and Safet/ E0ecuti%e
*nfection Control Nurses (ssociation
*nstitute of )ealthcare En&ineerin& and Estate 1ana&ement
*nstitute of Sterile Ser%ices 1ana&ement
1edical Sterile .roducts (ssociation
.u'lic )ealth a'orator/ Ser%ice
2o/al Colle&e of .atholo&ists
2o/al .harmaceutical Societ/ of 3reat Britain
Societ/ for 3eneral 1icro'iolo&/
"ontents
.a&e
Committees responsi'le *nside front co%er
National foreword4444444444444444444444444444444444444444444444ii
!oreword 2
Te0t of EN 285 444 4444444444444444444444444444444444444444444444"
This British Standard# ha%in& 'een prepared under the direction of the Sector Board for 1aterials and Chemicals# was pu'lished
under the authorit/ of the Standards Board and comes into effect on 15 Septem'er 1995
6 BS*1995
The followin& BS* references relate to the wor7 on this standard:
Committee reference B*8"5
,raft for comment 92858129 ,C
ISBN ( 58( 27)*5 +
National %ore,or'
This British Standard has 'een prepared '/ Technical Committee B!"5# and is the En&lish lan&ua&e %ersion
of EN 285 : 1996 Sterilization : Steam sterilizer's : Large stettiizers, pu'lished '/ the European Committee for
Standardi$ation +CEN-; *t supersedes BS "95<: .art " : 199<# which is withdrawn; *t also supersedes the current
pro%isions of BS "95<: .art 1: 199<# which is su'=ect to amendment
Steam sterili$ers fallin& within the scope of this standard are considered to 'e medical de%ices under ,irecti%e
9"8928EEC and compliance with the re>uirements of the standard is a means of ensurin& that particular essential
re>uirements of the ,irecti%e are met +see anne0 ?( of this standard-;
(ttention is drawn to @nited Ain&dom statutor/ re>uirements pertainin& to sterili$ers and their use; (ttention
is also drawn to the &uidance contained within )ealth Technical 1emorandum +)T1- 2<1<# pu'lished '/ the
,epartment of )ealth;
*SB 228C1 BS 2559 : 1986 Specification for pipe threads for tubes and
fittings wJiere pressure-tight joints are not made on the threads (metric dimensions)
EN *SB "596 : 1995 BS EN *SB "596 : 1996 Acoustics !etermination of sound
power le"els of noise sources using sound pressure Sur"e# method using an en"eloping measurement
surface o"er a reflecting plane
*SB 9<15 BS EN 29<15 : 1992 $e%agon head screws &roduct grades A
and'
"om#lian-e ,it& a Britis& Stan'ar' 'oes not o% itsel% -on%er imm.nit/
%rom le!al o$li!ations.
"ross0re%eren-es
1.$li-ation re%erre' to "orres#on'in! Britis& Stan'ar'
BS EN 1<<88 Stainless steels
EN 1<<88C1 BS EN 1<<88C1: 1995 List of stainless steels
EN 1<<88C2 BS EN 1<<88C2 : 1995 (echnical deli"er# conditions for sheet)plate and strip for general
purposes
EN 1<<88C" BS EN 1<<88C" : 1995 (echnical deli"er# conditions for semi-finished products, bars, rods
and sections for general purposes
BS EN 5<<81 *lectromagnetic compatibilit#
+eneric emission standard
EN 5<<81C1 BS EN 5<<81C1: 1992 ,esidential, commercial and light industr#
EN 5<<81C2 BS EN 5<<81C2 : 1999 -ndustrial en"ironment
BS EN 5<<82 *lectromagnetic compatibilit#
+enetic immunit# standard
EN 5<<82C1 BS EN 5<<82C1: 1992 ,esidential, commercial and light industr#
EN 5<<82C2 BS EN 5<<82C2 : 1995 -ndustrial en"ironment
BS EN 6<2<9 Safet# of machiner#
*lectrical e.uipment of machines
EN 6<2<9C1: 1992 BS EN 6<2<9C1: 199" Specification for general re.uirements
BS EN 6<589 (hermocouples
EN 6<589C2 : 199" BS EN 6<589C2 : 199" (olerances
EN 6<651:1999 BS EN 6<651: 1999 Specification for sound le"el meters
EN 6<551:1995 BS EN 6<551: 1996 -ndustrial platinum resistance thermometer sensors
EN 6<8<9 :1999 BS EN 6<8<9 : 1999 Specification far integrating-a"/aging sound le"el meters
BS EN 61<1< Safet# re.uirements for electrial e.uipment for measurement, control and laborator#
use
EN 61<1<C1 BS EN 61<1<C1: 199" +eneral re.uirements
EN 61<1<C2C<91 BS EN 61<1<C2C<91: 1995 &articular re.uirements for autocla"es using steam for the
treatment of medical materials, and for laborator# processes
E@2B.E(N ST(N,(2, EN 285
NB21E E@2B.EENNE
E2R31AIS"HE N3R4 Bcto'er 1996
*CS 11;<8<
,escriptors: Sterili$ation# medical e>uipment# sterili$ers# water %apour# e>uipment specifications# loc7in& de%ices# doors# fittin&s#
measurin& instruments# indicatin& instruments# specifications
En&lish %ersion
Sterili$ation : Steam sterili$ers : ai&e sterili$ers
Sterilisation C Sterilisateurs a la %apeur dDeau : Sterilisation : ,ampfCSterilisatoren :
3rands Sterilisateurs 3rofiCSterilisatoren
This European Standard was appro%ed '/ CEN on 1996C<9C19; CEN mem'ers are 'ound to compl/ with the
CEN8CENEEC *nternal 2e&ulations which stipulate the conditions for &i%in& this European Standard the status
of a national standard without an/ alteration;
@pCtoCdate lists and 'i'lio&raphical references concernin& such national standards ma/ 'e o'tained on application
to the Central Secretariat or to an/ CEN mem'er;
This European Standard e0ists in three official %ersions +En&lish# !rench# 3erman-; ( %ersion in an/ other lan&ua&e
made '/ translation under the responsi'ilit/ of a CEN mem'er into its own lan&ua&e and notified to the Central
Secretariat has the same status as the official %ersions;
CEN mem'ers are the national standards 'odies of (ustria# Bel&ium# ,enmar7# !inland# !rance# 3erman/# 3reece#
*celand# *reland# *tal/# u0em'our&# Netherlands# Norwa/# .ortu&al# Spain# Sweden# Swit$erland and @nited Ain&dom;
European Committee for Standardi$ation Comite Europeen de Normalisation Europaisches Aomitee fur
Normun&
"entral Se-retariat: r.e 'e Stassart *)5 B01(5( Br.ssels
6ore,or'
This European Standard has 'een prepared '/ Technical Committee CEN8TC 1<2# Sterili$ers for medical purposes#
N
the secretariat of which is held '/ ,*N;
This European Standard shall 'e &i%en the status of a national standard# either '/ pu'lication of an identical te0t or
'/ endorsement# at the latest '/ (pril 1995# and conflictin& national standards shall 'e withdrawn at the latest '/
(pril 1995;
This European Standard has 'een prepared under a mandate &i%en to CEN '/ the European Commission and the
European !ree Trade (ssociation# and supports essential re>uirements of E@ ,irecti%e+s-; !or the relationship with
E@ ,irecti%e+s- see informati%e anne0 ?(# which is an inte&ral part of this standard;
This European Standard specifies re>uirements and the rele%ant tests for lar&e steam sterili$ers; Specifications of
re>uirements and tests for small steam sterili$ers as well as for sterili$ers usin& other sterilants than steam are in
preparation '/ CEN8TC 1<2;
This European Standard does not specif/ re>uirements for the %alidation and routine control of sterili$ation '/ moist
heat; ( European Standard specif/in& re>uirements for the %alidation and routine control of sterili$ation '/ moist
heat was prepared '/ CEN8TC 2<9# Sterili$ation of medical de%ices# see EN 559 Sterilization of medical de"ices :
0alidation and routine control of sterilization b# moist heat (ccordin& to the CEN8CENEEC *nternal 2e&ulations#
the national standards or&ani$ations of the followin& countries are 'ound to implement this European Standard:
(ustria# Bel&ium# ,enmar7# !inland# !rance# 3erman/# 3reece# *celand# *reland# *tal/# u0em'our&# Netherlands#
Norwa/# .ortu&al# Spain# Sweden# Swit$erland and the @nited Ain&dom;
"ontents
.a&e
!oreword 2
1 Scope "
2 Normati%e references "
" ,efinitions 9
9 1echanical components 5
5 .rocess components 5
6 *nstrumentation C *ndication and
re&istration de%ices 8
5 Control s/tems 1"
8 .erformance re>uirements 19
9 Sound power 15
1< 2ate of pressure chan&e 15
11 Safet/ 15
12 1ar7in& 15
1" Ser%ice and local en%ironment 15
19 *nstallation chec7s 15
15 Cate&ories of tests 15
16 Test pro&rammes 15
15 1icro'iolo&ical tests 19
18 Thermometric tests 2<
19 Bowie and ,ic7 test 2"
2< (ir lea7a&e test 2"
21 (ir detector tests 29
22 oad dr/ness tests 25
2" Sound power test 25
29 Steam >ualit/ tests 28
25 ,/namic sterili$er cham'er pressure
test "5
26 Test apparatus# e>uipment and
material "5
25 ,ocumentation "9
28 *nformation "9
Anne7es
( +informati%e- 2ecommended materials 9<
B +informati%e- Su&&ested ma0imum
%alues of steam contaminants 92
C +informati%e- Bi'lio&raph/ 9"
?( +informati%e- Clauses of this European Standard addressin& essential re>uirements or other pro%isions
of
E@ ,irecti%es 99
1 S-o#e
1.1 This European Standard specifies re>uirements and the rele%ant tests for lar&e steam sterili$ers primaril/ used in
health care for the sterili$ation of one or more sterili$ation modules for wrapped &oods +instruments etc; and porous
loads-;
ar&e steam sterili$ers can also 'e used durin& the commercial production of medical de%ices;
NBTE; Sterili$ers conformin& to this standard can offer a sin&le automatic sterili$ation c/cle or a num'er of selecta'le automatic sterili$ation
c/cles# e;&; with different operatin& temperatures +see 28;"'-E;
1;2 This European Standard is not applica'le to small steam sterili$ers or to steam sterili$ers used for the
sterili$ation of pharmaceutical products in containers;
NBTE; The use of sterili$ers for unwrapped instruments and utensils for immediate use in aseptic areas and for fluidCsterili$ers will 'e the
su'=ect of a separate standard;
1.* This European Standard does not descri'e a >ualit/ assurance s/stem for the control of all sta&es of the
manufacture of the sterili$er;
NBTE; (ttention is drawn to the standards for >ualit/ s/stems +see EN *SB 9<<1# EN *SB 9<<2# EN *SB 9<<99 and EN 96<<1 and EN 96<<2-;
2 Normati8e re%eren-es
This European Standard incorporates# '/ dated or undated reference# pro%isions from other pu'lications; These
normati%e references are cited at the appropriate places in the te0t and the pu'lications are listed hereafter; !or
dated references# su'se>uent amendments to or re%isions of an/ of these pu'lications appl/ to this European
Standard onl/ when incorporated in it '/ amendment or re%ision; !or undated references# the latest edition of the
pu'lication referred to applies;
prEN 866C1 'iological s#stems for testing
sterilizers : &art 12 +eneral re.uirements
prEN 866C" 'iological s#stems for testing
sterilizers : &art 32 &articular s#stems for use in steam sterilizers
prEN 865C" 4on-biological s#stems for use in
sterilizers : &art 32 Specification for class ' indicators for use in the 'owie and !ic5 test
prEN 868C5 &ac5aging materials for sterilization
of wrapped goods : &art 62 $eat scalable pouches and reel material of paper and plastic
construction : ,e.uirements and tests
EN 1<<88C1 Stainless steels : &art 12 List of
stainless steels
EN 1<<88C2 Stainless steels 7 &art 82 (echnical
deli"er# conditions for sheet)plate and strip for general purposes
EN 1<<88C" Stainless steels : &art 32 (echnical
deli"er# conditions for semi-finished products, bars, rods and sections fen9 general purposes
EN 5<<81C1 *lectromagnetic compatibilit# :
+eneric emission standard : &art 12 ,esidential, commercial and light industr#
+eneric emission standard 7 &a$ 82 -ndustrial en"ironment
+eneric immunit# standard : &art 12 ,esidential, commercial and light industr#
+eneric immunit# standard : &art 82 -ndustrial en"ironment
EN 6<2<9C1: Safet# of jnachiner# : *lectrical,
1992 e.uipment of machines :
&art 12 +eneral re.uirements
+*EC 2<9C1: 1992# modified-
EN 6<589C2: (liermocouples : &art 82 (olerances
199" +TEC 589C2 : 1982 F (l: 1989-
EN 6<651:1999 Sound le"el meters
+*EC 651: 1959 F (l: 199"-
EN 6<551: 1995 -ndustrial platinum resistance thei/nometej9 sensors +*EC 551: 198" F (l : 1986-
EN 6<8<9:1999 -ntegrating-a"eraging sound le"el
meters +*EC 8<9: 1985 F (l : 1989-
EN 61<1<C1 Safet# re.uirements for electrical e.uipment for measurement, control and laborator# use : &art
12 +eneral re.uirements +*EC 1<1<C1: 199< F (l : 1992# modified- EN 61<1<C2C<91 Safet# re.uirements for electrical
e.uipment for measurement, control and laborator# use - &art 8-:;12
&articular re.uirements fen- autocla"es using steam for the treatment of medical materials, and for laborator#
processes +*EC 1<1<C2C<91:1996- *EC "8 -*< standard "oltages
*SB 228C1 &ipe flireads where pressure-tight
joints are not made on the threads : &art 12 !imensions, tolerances and designation
EN *SB "596: Acoustics : !etermination of sound
1995 power le"els of noise sources using
sound pressure : Sur"e# method using an en"eloping measurement surface o"er a reflecting
plane +*SB "596: 1995-
*SB 9<15$e%agon head screws : &roduct grades A and '

* De%initions
!or the purposes of this standard the definitions of
EN 569 appl/# to&ether with the followin&;
NBTE; Bther definitions rele%ant to %alidation are &i%en in EN 559;
*.1 a-ti8e 'rain
,rain which is situated at the lowest part of the sterili$er cham'er to control the dischar&e of air8nonCcondensa'le
&ases or air and condensate from the sterili$er cham'er;
*.2 air remo8al
2emo%al of air from the sterili$er cham'er and sterili$er load sufficient to facilitate steam penetration;
*.* a.tomati- -ontroller
,e%ice that# in response to preCdetermined c/cle %aria'les# operates the sterili$er se>uentiall/ throu&h the re>uired
sta&es of the c/cle+s-;
*.9 $iolo!i-al in'i-ator
(n inoculated carrier contained within its primar/ pac7 read/ for use +prEN 866C1-;
*.5 -ali$ration
The set of operations that esta'lish# under specified conditions# the relationship 'etween %alues of a >uantit/
indicated '/ a measurin& instrument or measurin& s/stem# or %alues represented '/ a material measure or a
reference material# and the correspondin& %alues reali$ed '/ standards;
*.) -&am$er 'e#t&
,epth of the sterili$er cham'er which is a%aila'le for the sterili$er load;
*.7 -&am$er &ei!&t
)ei&ht of the sterili$er cham'er which is a%aila'le for the sterili$er load;
*.8 -&am$er ,i't&
Gidth of the sterili$er cham'er which is a%aila'le for the sterili$er load;
*.9 -&am$er tem#erat.re
owest temperature pre%ailin& in the sterili$er cham'er +EN 559-;
*.1( -/-le -om#lete
*ndication that the sterili$ation c/cle has 'een satisfactoril/ completed and that the sterili$ed load is read/ for
remo%al from the sterili$er cham'er;
*.11 'e'i-ate' steam s.##l/
Suppl/ of steam produced for a sterili$er# or &roup of sterili$ers# '/ a dedicated &enerator;
*.12 'oor
id or similar de%ice pro%ided as a means of closin& and sealin& the sterili$er cham'er;
*.1* 'o.$le en'e' sterilizer
Sterili$er in which there is a door at each end of the sterili$er cham'er;
*.19 'r/ sat.rate' steam
Steam with a temperature and pressure correspondin& to the %apori$ation cur%e of water;
NBTE; This is an ideal condition which can de%iate towards either superheated steam or to wet steam; This de%iation is >uantified '/ the
determination of the ,r/ness Halue;
*.15 e:.ili$ration time
.eriod which elapses 'etween the attainment of the sterili$ation temperature in the sterili$er cham'er and the
attainment of the sterili$ation temperature at all points within the load +EN 559-;
*.1) %ail sa%e
(ttri'ute of sterili$er desi&n# component or its associated ser%ices that minimi$es a possi'le safet/ ha$ard;
*.17 %a.lt
2eco&nition '/ the automatic controller that the preCset c/cle %aria'les for the sterili$ation c/cle ha%e not 'een
attained;
*.18 &ol'in! time
.eriod for which the temperature of all points within the sterili$er is held within the sterili$ation temperature 'and;
NBTE; The holdin& time follows immediatel/ after the e>uili'ration time; The e0tent of the holdin& time is related to the sterili$ation
temperature;
*.19 ino-.late' -arrier
( carrier on which a defined num'er of test or&anisms has 'een deposited +prEN 866C1-;
*.2( installation test
Series of chec7s and tests performed after installation of the sterili$er in the place of use +EN 559-;
*.21 loa'in! 'oor
,oor in a dou'leCended sterili$er throu&h which the sterili$er load is put into the sterili$er cham'er prior to
sterili$ation;
*.22 me'i-al 'e8i-e
The definition &i%en in EN 96<<1 applies;
*.2* non0-on'ensa$le !as
(ir and other &as which will not condense under the conditions of steam sterili$ation;
*.29 #latea. #erio'
E>uili'ration time plus the holdin& time;
*.25 #ress.re 8essel
( %essel descri'in& the sterili$er cham'er# =ac7et +if fitted-# door+s- and components that are in permanent
connection with the sterili$er cham'er;
*.2) re%eren-e meas.rement #oint
2eference point for which documented e%idence is a%aila'le to demonstrate that it has a 7nown relationship to the
temperature of the coolest part of the sterili$er cham'er;
*.27 re%eren-e stan'ar'
Standard# &enerall/ ha%in& the hi&hest metrolo&ical >ualit/ a%aila'le at a &i%en location or in a &i%en or&ani$ation#
from which measurements made there are deri%ed;
*.28 sa%et/ &azar'
.otentiall/ detrimental effect on persons or the surroundin&s arisin& directl/ from either the sterili$er or its load;
*.29 small steam sterilizer
Steam sterili$er which is una'le to accommodate a sterili$ation module;
*.*( sterile
Condition of a medical de%ice that is free from %ia'le microCor&anisms +EN 556-;
*.*1 sterilization
.rocess underta7en to render a sterili$er load sterile;
*.*2 sterilization -/-le
(utomatic se>uence of operatin& sta&es performed in a sterili$er for the purpose of sterili$ation +EN 559-;
*.** sterilization mo'.le
2ectan&ular parallelepiped of the dimensions
"<< mm I "<< mm I 6<< mm used for the puiposes of
sterili$ation;
*.*9 sterilization tem#erat.re
1inimum temperature of the sterili$ation temperature 'and +EN 559-;
*.*5 sterilization tem#erat.re $an'
2an&e of temperatures# e0pressed as the sterili$ation temperature and the ma0imum allowa'le temperature which
ma/ pre%ail throu&hout the load durin& the holdin& time +EN 559-;
NBTE; These temperatures are usuall/ stated in whole de&rees Celsius;
*.*) sterilizer
(pparatus desi&ned to achie%e sterili$ation;
*.*7 sterilizer -&am$er
That part of the sterili$er which recei%es the sterili$er load +EN 559-;
*.*8 sterilizer loa'
3oods that are to 'e sterili$ed simultaneousl/ in the same sterili$er cham'er +EN 559-;
*.*9 s.#er&eate' steam
Steam whose temperature# at an/ &i%en pressure# is hi&her than that indicated '/ the %apori$ation cur%e of water;
*.9( test or!anism
1croCor&anisms used for the manufacture of inoculated carriers +prEN 866C1-;
*.91 t/#e test
Series of tests to esta'lish the wor7in& data for a sterili$er t/pe;
*.92 .nloa'in! 'oor
,oor in a dou'leCended sterili$er throu&h which the sterili$ed load is remo%ed from the sterili$er cham'er after a
sterili$ation c/cle;
*.9* .sa$le s#a-e
Space inside the sterili$er cham'er which is not restricted '/ fi0ed parts and which is conse>uentl/ a%aila'le to
accept the sterili$er load;
NBTE; The usa'le space is e0pressed in terms of cham'er hei&ht# cham'er width and cham'er depth;
*.99 ,or;s test
Series of tests performed at the manufacturerDs wor7s to demonstrate compliance of each sterili$er with its
specification;
9 4e-&ani-al -om#onents
9.1 Dimensions
The usa'le space within the sterili$er cham'er shall accommodate one or more sterili$ation modules;
9.2 4aterials
1aterials in contact with steam shall:
C resist attac7 from steam and condensateJ
C not cause deterioration of the >ualit/ of the steamJ
NBTE 1; 3uidance is &i%en in anne0 B;
C not release an/ su'stances 7nown to 'e to0ic in
such >uantities as could create a health ha$ard;
NBTE 2; Because of the different t/pes of sterili$ers and the lar&e num'er of uses# it is not possi'le to specif/ detailed re>uirements for
materials for specific applications; The purchaser should pro%ide the manufacturer with information a'out the &oods to 'e sterili$ed;
NBTE "; (d%ice on the %arious com'inations of materials is &i%en in anne0 (;
9.* 1ress.re e:.i#ment
9.*.1 General
9;";1;1 ( Council ,irecti%e on the appro0imation of the laws of the mem'er states concernin& pressure e>uipment
+see 9"8C2968<1- and correspondin& European Standards are in preparation +CEN8TC 59 and CEN8TC 269-; @ntil
European Standards on pressure e>uipment are pu'lished# the pressure e>uipment should compl/ with national
re&ulations and standards appl/in& in the countr/ of intended use;
9;";1;2 Sterili$ers shall 'e pro%ided with one or two doors;
9;";1;" The door seal shall 'e a replacea'le component;
*t shall 'e possi'le to inspect and clean the surface of the door seal which comes into contact with the sealin&
faces without the need to dismantle the door assem'l/;
9;";1;9 (fter closin& the sterili$er door# it shall 'e possi'le to open it without ha%in& first to initiate a
9;";1;5 E0cept in the case of a fault# it shall not 'e possi'le to open a sterili$er door+s- durin& a sterili$ation c/cle;
9.*.2 Double-ended sterilizers
9;";2;1 E0cept for maintenance purposes# it shall not 'e possi'le for more than one door to 'e open at one time;
9;";2;2 *t shall not 'e possi'le to open the unloadin& door until a Dc/cle completeD indication is o'tained;
9;";2;" *t shall not 'e possi'le to open the unloadin& door if a Bowie and ,ic7 test has 'een carried out
9;";2;9 The control used to start the sterili$ation c/cle shall 'e located at the loadin& side of the sterili$er;
9.*.* Test connections
9.*.*.1 *f the sterili$ation c/cle includes a %acuum sta&e# a test connection in accordance with fi&ure 1 shall 'e
fitted to the sterili$er cham'er or in a pipe which is in direct connection with the sterili$er cham'er +e0cludin&
%acuum line-; The test connection which is used for the connection of a test instrument shall 'e pro%ided with a
standard cap# mar7ed HT +%acuum test- and sealed with either an BCrin&Cseal or a flat seal;
9.*.*.2 ( strai&ht connectin& slee%e# in accordance with fi&ure 2# shall 'e pro%ided at a point of eas/ access in
order to pass at least si0 fle0i'le cords to the temperature sensors;
6i!.re 2. "onne-tion slee8e %or t&ermoelements
The connectin& slee%e with its BCrin&Cseal or flat seal shall 'e closed with a standard cap# and a temperature proof
and mechanicall/ resistant soft pac7in&; The cap shall 'e mar7ed with the letters TT +temperature test-;
9.*.*.* Test tees and %al%e coc7s with sealin& plu&s shall 'e fitted to permit connection of reference instruments for
the cali'ration of all pressure instruments# connected to the sterili$er cham'er and =ac7et +see ).1.2 and ).1.9<.
9.*.9 Insulating material
E0cept where insulation would interfere with the function and operation of the sterili$er# e0ternal surfaces shall
'e insulated to minimi$e heat transmission to the en%ironment such that the temperature of the outer surface of
the insulatin& material does not e0ceed 55 KC when tested in an en%ironmental temperature of +2" L 2- KC;
9.9 6rame,or; an' #anellin!
9;9;1 Ghere the sides of the sterili$er are %isi'le from the user area# the/ shall 'e enclosed with panellin&; The
manufacturer shall pro%ide instructions for the cleanin& of the panellin&;
NBTE; The panellin& should ha%e a corrosionCresistant finish to the cleanin& a&ents specified '/ the manufacturer;
9;9;2 The panellin& of the sterili$er shall allow access for maintenance wor7 +for e0ample# '/ the use of a special
7e/# code or tool-; Such panellin& shall 'e demounta'le or the dimensions of an/ personal access shall 'e not less
than 5<< mm wide and not less
than 15<< mm hi&h# and the access shall not 'e o'structed;
NBTE 1; *f the pressure e>uipment is housed in a frame# this frame should not promote corrosion of the e>uipment;
NBTE 2; The access for maintenance should 'e positioned so that it will not compromise the safet/ of either the product or persons;
9;9;" The panellin& shall 'e desi&ned to pro%ide a continuous contact with the surfaces of the 'uildin& in which it is
installed when these surfaces are within the tolerances &i%en in ta'les 1 and 2;
Sterili$ers desi&ned for incorporation into e0istin& 'uildin&s or purpose 'uilt rooms shall pro%ide a continuous =oint
with ad=acent surfaces when these are within the tolerances &i%en in ta'les 1 and 2;
Ta$le 1. Toleran-es %or t&e a#ert.re into
,&i-& t&e sterilizer is installe'
Dimension
m
Toleran-e
mm
Horizontal #lane =erti-al #lane
.# to * >12 >1)
a$o8e * to ) >1) >1)
a$o8e ) to 15 >29 >2(
a$o8e 15 to *( >29 >2(
a$o8e *( >*( >*(
Ta'le 2; Tolerances for %ertical and hori$ontal
flatness
,istance
'etween
chec7points
m
Tolerance
mm
!inished surfaces of
walls and ceilin&s
!inished floor
+'earin& surface-
<#1
" 2
1
5 9
9 1< 1<
1< 2< 12
15 25 15
5 1ro-ess -om#onents
5.1 1i#e,or; an' %ittin!s
5;1;1 .ipe =oints and fittin&s shall 'e 'oth pressureCti&ht and %acuumCti&ht;
5;1;2 E0cept where this will interfere with the function of the sterili$er# the pipewor7 for steam or water at a
temperature &reater than 6< KC shall 'e thermall/ insulated to minimi$e heat transmission to the en%ironment The
temperature of the outer surface of insulation material shall not e0ceed 55 KC when tested in an en%ironmental
temperature of +2" L 2- KC +see 9;";9-;
NBTE; To minimi$e the formation of condensation cold water pipewor7 should 'e insulated;
5;1;" (t least one strainer shall 'e fitted on each ser%ice suppl/ line upstream of the first %al%e on the sterili$er for
that ser%ice; The si$e of the strainer selected shall pre%ent particles passin& which would affect the correct operation
of the %al%e;
5;1;9 (ll control %al%es in the pipewor7 shall 'e mar7ed with permanent identification in relation to their functions
+see 12.*<.
NBTE; 2eference num'ers or written descriptions can 'e used;
5.2 ?enerator %or 'e'i-ate' steam s.##l/ an' %or sterilizers ,&ere t&e steam is !enerate' in t&e
sterilizer -&am$er
5;2;1 ( Council ,irecti%e on the appro0imation of the laws of the mem'er states concernin& pressure e>uipment
European Standards on pressure e>uipment are pu'lished# the pressure e>uipment should compl/ with national
re&ulations and standards appl/in& in the countr/ of intended use;
5;2;2 The feed water inlet shall 'e desi&ned to pre%ent 'ac7Csiphonin& into the feed water s/stem;
NBTE; This will normall/ re>uire the use of a 'rea7 tan7 which should 'e made from material resistant to water at 1<< KC;
5;2;" The power re>uirements and the capacit/ of the steam &enerator shall 'e sufficient to ensure that the steam
demand specified for the sterili$er can 'e met;
5;2;9 The manufacturer shall specif/ the >ualit/ of feedwater re>uired; *n particular# the ma0imum hardness %alue#
the ran&e of p) and the conducti%it/ shall 'e specified +see 28;2 and ta'le B;*-;
5.* Air %ilter
5;";1 Ghere the sterili$ation c/cle re>uires the admission of air into the sterili$er cham'er direct from the
atmosphere# the air shall 'e admitted throu&h a filter;
NBTE; (ir filters should 'e constructed from material resistant to coiTBsion and 'iode&radation; The filter material should 'e supported in a
manner which minimi$es dama&e to the filter medium;
5;";2 The filter shall retain not less than 99#5 M of particles &reater than <#"< f=un;
5;";" The filter unit shall 'e readil/ accessi'le and shall 'e mounted e0ternall/ to the sterili$er cham'er in such a
manner that the filter material is 7ept dr/;
5;";9 ( nonCreturn %al%e shall 'e fitted 'etween the filter and the sterili$er cham'er to pre%ent steam penetration
from the sterili$er cham'er into the filter;
5.9 =a-..m s/stem
The %acuum s/stem shall 'e capa'le of e%acuatin& the sterili$er cham'er to an ultimate pressure e>ual to or less
than 5< m'ar a'solute +5 7.a-;
NBTE; ( pressure e>ual to or less than 9< m'ar +9 7.a- can 'e necessar/ to meet the load dr/ness and the air detector re>uirements +see
8.*.2.* and 8;";2;9-;
) Instr.mentation 0 In'i-ation an' re!istration 'e8i-es
).1 E:.i#ment
).1.1 General
6;1;1;1 (ll instruments and indicatin& de%ices specified in clause 6 shall 'e located in a position where the/ can
'e readil/ %iewed '/ the operator under normal operation of the sterili$er and shall 'e identified as to their function;
6;1;1;2 @nless otherwise specified# instruments and &au&es shall 'e reada'le '/ normal or corrected %ision from a
distance of 1 m and with a minimum e0ternal illumination of +215 L 15- *0;
6;1;1;" *nstruments and &au&es shall 'e located such that the ma0imum %alues of temperature and humidit/
specified '/ the instrumentsD and &au&esD manufacturer is not e0ceeded;
NBTE; Normall/ the temperature and relati%e humidit/ in the %icinit/ of instruments and &au&es should not e0ceed 5< KC and 85 M relati%e
humidit/ respecti%el/ +'ut see also 1*.9<.
).1.2 Instruments
Sterili$ers shall 'e pro%ided with at least the followin& instruments:
a- sterili$er cham'er temperature indicatin& instrumentJ
'-sterili$er cham'er temperature recorderJ
c- sterili$er cham'er pressure indicatin& instrumentJ
d-sterili$er cham'er pressure recorderJ
e- =ac7et pressure indicatin& instrument +if the sterili$er is fitted with a =ac7et-J
f- steam pressure &au&e if dedicated steam &enerator +fitted to the steam &enerator- is used;
NBTE 1; Some of these instruments can 'e re>uired '/ EN 61<1<C2C<91;
NBTE 2; *tems '- and d- can 'e com'ined;
NBTE "; (n a'solute pressure indicator for routine lea7 rate testin& can 'e re>uired '/ the user;
).1.* Indicating devices
Sterili$ers shall 'e pro%ided with at least the followin& indicatin& de%ices:
a- %isual displa/ indicatin& Ddoor+s- loc7edDJ
'- %isual displa/ indicatin& Din pro&ressDJ
c- %isual displa/ indicatin& Nc/cle completeDJ
d- %isual displa/ indicatin& DfaultD +see 5;2-J
e- indication of the sterili$ation c/cle selectedJ
f- sterili$ation c/cle counter#
&- sterili$ation c/cle sta&e indication;
NBTE; This can incorporate items a-# '- and c-;
The Dc/cle completeD indication shall 'e cancelled when the openin& of the door has 'een initiated;
).1.9 Double-ended sterilizer
Both ends of the sterili$er shall 'e pro%ided with at least:
a- sterili$er cham'er pressure indicatin& instrumentJ
'- %isual displa/ indicatin& Ddoors loc7edDJ
c- %isual displa/ indicatin& Din pro&ressDJ
d- %isual displa/ indicatin& Dc/cle completeDJ
e- %isual displa/ indicatin& DfaultD +see 5;2-;
).2 Sensors5 in'i-atin! instr.ments an' time e:.i#ment
).2.1 Temperature
).2.1.1 (emperature sensors
Temperature sensors shall 'e either platinum
resistance t/pes compl/in& with Class ( of
EN 6<551:1995 or thermocouples compl/in& with one
of the ta'les specified in tolerance class 1 of
EN 6<589C2:199";
NBTE; Bther s/stems of demonstrated e>ui%alence can 'e used;
The temperature sensor shall ha%e a response time TB O 5 s when tested in water;
(t least two independent temperature sensors shall 'e pro%ided; These sensors shall 'e connected to the steriliser
cham'er temperature indicatin& instrument# temperature recorder and temperature controller as indicated in fi&ure
"# a- and '-; The arran&ement illustrated in fi&ure "# c- and d- shall not 'e permitted The sensor used for the control
of the sterili$ation c/cle and for the indication of the sterili$er cham'er temperature shall 'e located in the acti%e
drain; *f the drain is not acti%e# the sensor shall 'e located at the reference measurement point;
).2.1.2 =o"eable tempetuture sensors inside sterilizers
Ghere a mo%ea'le temperature sensor and its wirin& is located inside the sterili$er cham'er# it shall 'e manufactured
in such a wa/ as to 'e temperature resistant as well as pressureCti&ht# %acuumCti&ht and steamCti&ht;
1 Cham'er
Sterili$er cham'er
temperature indicatin&
instrument
TemperatureC
recorder
6i!.re *. 1ossi$le arran!ement o% tem#erat.re sensors
Control of plateau period '/ temperature
).2.1.* Sterilizer chamber temperature indicating instrument
The sterili$er cham'er temperature indicatin& instrument shall:
a- 'e either di&ital or analo&ueJ
'- 'e &raduated in de&rees CelsiusJ
c- ha%e a scale which includes the ran&e 5< KC to
15< KCJ
d- ha%e an accurac/ of at least 7 1> o%er the scale ran&e 5< KC to 15< KCJ
e- for analo&ue instruments# 'e &raduated in di%isions not &reater than 2 KCJ
f- for di&ital instruments# ha%e a resolution of at least <#1 KCJ
&- 'e ad=usted to an accurac/ of at least L <#5 KC at the sterili$ation temperatureJ
h- when used for a control function# ha%e 'ro7en sensor protection to fail safe in its control function application
+see 5;1-J
=- ha%e an am'ient temperature error compensation not e0ceedin& <#<9 A8AJ
7- ha%e means to ad=ust in situ '/ the use of a special 7e/# code or tool without dismantlin& the instrument
).2.2 Pressure
).2.2.1 Sterilizer chamber pressure itidicating instrument
The sterili$er cham'er pressure indicatin& instrument shall:
'- 'e &raduated in 'ars or 1lopascalsJ
c- ha%e a scale which includes the ran&e C1 'arn to " 'ar or < 7.a to 9<< 7.a with a $ero readin& at am'ient
pressure or a'solute %acuum respecti%el/J
d- ha%e an accurac/ of at least L 1#6 M o%er the scale ran&e C1 'ar to " 'ar +< 7.a to 9<< 7.a-J
e- for analo&ue instruments# 'e &raduated in di%isions not &reater than <#2 'ar +2< 7.a-J
f- for di&ital instruments# ha%e a resolution of at least <#<1 'ar +1 7.a-J
&- 'e ad=usted to an accurac/ of at least L <#<5 'ar +L 5 7.a- at the operatin& pressureJ
h- when used for a control function# ha%e 'ro7en sensor protection to fail safe in its control function application
+see 5;1-J
=- ha%e an am'ient temperature error compensation not e0ceedin& <#<9 M8A o%er the scale ran&e C1 'ar to " 'ar
+< 7.a to 9<< 7.a-J
7- ha%e means to ad=ust in situ '/ the use of a special 7e/# code or tool without dismantlin& the instrument
NBTE; Ghere di&ital pressure indicators are used# an additional mechanicall/ actuated indicator can 'e re>uired to compl/ with national
pressure %essel re&ulations; Ghere an analo&ue instrument is pro%ided onl/ for this purpose# the re>uirement for ad/ustment in situ is
wai%ed;
).2.2.2 Absolute pj?essure indicator
Ghere an a'solute pressure indicator is re>uired for lea7 rate testin& and is to 'e fitted to the sterili$er +see Note "
of 6;1;2- it shall:
'- 'e &raduated in milli'ars or 1opascalsJ
c- ha%e a scale which includes < m'ar to 16< m'ar a'solute +< 7.a to 16 7.a-J
d- ha%e an accurac/ of at least L 1 M o%er the scale ran&e < m'ar to 16< m'ar a'solute +< 7.a to 16 7.a-J
e- 'e &raduated in di%isions not &reater than 9 m'ar +<#9 7.a- and with the scale &reater than 1 m'ar8mm +<#1
7.a8mm- for analo&ue instrumentsJ
f- ha%e a resolution of at least 1 m'ar +<#1 7.a- for di&ital instrumentsJ
&-ha%e means to ad=ust in situ '/ the use of a special 7e/# code or tool without dismantlin& the instrument
).2.* Time indicating equipment
*f time indicators are fitted the/ shall:
a- 'e &raduated in seconds or minutesJ
'- ha%e an accurac/ of at least L 2#5 M for periods up to 5 min and at least L 1 M for periods a'o%e 5 minJ
c- ha%e means to ad=ust in situ '/ means of a special 7e/# code or tool;
).* Re-or'ers an' re-or's ).*.1 General
6;";1;1 The recorder shall 'e either analo&ue or di&ital;
6;";1;2 The recorder shall 'e independent of the automatic controller;
6;";1;" 2ecords shall include the limitin& %alues for all c/cle %aria'les throu&hout the sterili$ation c/cle;
The printin& of data shall 'e sufficient to ensure that an/ de%iation outside permitted tolerances can 'e identified
+see also clause 8-;
NBTE; !i&ure 9 and ta'le " illustrate the points where c/cle %aria'les should 'e recorded for a specimen sterili$ation c/cle;
Ta'le "; E0amples of limitin& %alues to 'e recorded
.ro&ramme
step
Time
Temperature
+measured %alue-
.ressure
+measured %alue-
Steili$ation
1
-
,ate
1P
and
sterili$er
identification
c/cle
identification
Counter No;
BN
I I
ST(2T I I I I
Qsi I
I2-
Ds% I
I2-
Dpp
I I
I
Reh I
I I
Rsd
I I
Red
I I
EN, I
B!! I
R Bptional
2
- !or
each chan&e
Ssi C time at the start of the first steam in=ection t -
time at the start of the second %acuum pulse t -
time at the start of the plateau period Seh C time at
the end of the holdin& time S&d C time at the start of
the dr/in& period Sed C time at the end of the dr/in&
period
6;";1;9 The recorder shall produce a permanent record;
6;";1;5 2ecords shall 'e reada'le when %iewed at a distance of 25< mm with normal or corrected %ision in an
illumination of +215 7 15- *0;
6;";1;6 *f times are mar7ed# units shall 'e either in seconds or minutes or multiples thereof;
Time periods up to 5 min shall ha%e an accurac/ of at least L 2#5 M# and for periods a'o%e 5 min# of at least L 1 M;
).*.1.7 1eans shall 'e pro%ided to ad=ust the recorder
in situ '/ the use of a special 7e/# code or tool;
).*.2 Recorders producing analogue records
).*.2.1 <hart speed
2ecorders producin& analo&ue records shall ha%e a chart speed of not less than 9 mm8min;
).*.2.2 (emperature
Temperature recorders producin& analo&ue records shall:
a- ha%e a chart &raduated in de&rees CelsiusJ
'-ha%e a scale which includes the ran&e 5< KC to 15< KCJ
c- ha%e an accurac/ of at least L 1 M o%er the scale ran&e 5< KC to 15< KCJ
d-ha%e a chart with &raduated di%isions not &reater than2KCJ
e- ha%e a resolution of at least 1 KCJ
f- 'e ad=usted to an accurac/ of at least C 1 KC at the sterili$ation temperatureJ
&-ha%e a samplin& rate for each channel of at least 2#5 s;
).*.2.* &ressure
.ressure recorders producin& analo&ue records shall:
a- ha%e a chart &raduated in 'ars or 1lopascalsJ
'- ha%e a scale which includes the ran&e : 1 'ar to " 'ar or < 7.a to 9<< 7.a with a $ero readin& of am'ient
pressure or a'solute %acuum respecti%el/J
c- ha%e an accurac/ of at least - 1#6 M o%er the scale ran&e C1 'ar to " 'ar +< 7.a to 9<< 7.a-J
d-ha%e a chart &raduated in di%isions not &reater than <#2 'ar +2< 7.a-J
e- ha%e a resolution of at least <#<5 'ar +5 7.a-J
f- 'e ad=usted to an accurac/ of at least 7 <#<5 'ar +i 5 7.a- at the operatin& pressureJ
&-ha%e a samplin& rate for each channel of at least 1 s;
).*.* Recorders producing digital records
).*.*.1 (emperature
Temperature recorders producin& di&ital records shall:
a- ha%e alpha numeric charactersJ
'- ha%e data defined '/ te0tJ
c- ha%e a ran&e which includes 5< KC to 15< KCJ
d- ha%e a resolution of at least <#1 KCJ
e- ha%e an accurac/ of at least - 1> o%er the ran&e 5< KC to 15< KCJ
f- ha%e a paper width which has a space for a minimum of 15 characters8lineJ
&- ha%e a samplin& rate for each channel of at least 2#5 s;
).*.*.2 &ressure
.ressure recorders producin& di&ital records shall:
a- ha%e alpha numeric charactersJ
'- ha%e data defined '/ te0tJ
c- ha%e a ran&e which includes C1 'ar to " 'ar +< 7.a to 9<< 7.a-J
d- ha%e a resolution of at least <#<1 'ar +1 7.a-J
e- ha%e an accurac/ of at least L 1#6 M o%er the ran&e C1 'ar to " 'ar +< 7.a to 9<< 7.a-J
f- ha%e a paper width which has a space for a minimum of 15 characters8lineJ
&- ha%e a samplin& rate for each channel of at least 1 s;
7 "ontrol s/stems 7.1 ?eneral
5;1;1 The sterili$ation c/cle shall 'e controlled '/ an automatic controller which has one or more preCset
sterili$ation c/cles;
5;1;2 The automatic controller shall ensure that within specified limits the sterili$ation c/cle is reproduci'le durin&
su'se>uent sterili$ation c/cles;
NBTE 1; (utomatic loadin& and unloadin& can 'e performed 'efore the sterili$ation c/cle start and after a Dc/cle completeD; NBTE 2;
.ro%ision can 'e made to ad=ust the c/cle %aria'les for each sta&e of the preCset sterili$ation c/cle+s-;
5;1;" The manufacturer shall specif/ the limits for each c/cle %aria'le pro&rammed into the automatic controller
such that the performance re>uirements in 8;" are met;
5;1;9 ( de%ice shall 'e fitted such that if a failure of the automatic controller occurs# the pressure within the
sterili$er cham'er can 'e returned to atmospheric pressure safel/ and allow the loadin& door to 'e opened;
5;1;5 The sterili$er cham'er temperature indicatin& instrument and the sterili$er cham'er pressure indicatin&
instrument shall ha%e 'ro7en sensor protection +see ).2.1.* an' ).2.2.1<.
5;1;6 Time periods up to 5 min shall 'e controlled to an accurac/ of at least L 2#5 M and for periods a'o%e 5 min of
at least L 1 M;
5;1;5 (ccess to control de%ices shall onl/ 'e possi'le '/ the use of a special 7e/# code or tool;
5;1;8 !or maintenance# test purposes and in cases of emer&enc/# means shall 'e pro%ided to permit manual
pro&ression of the automatic controller pro&ramme; The selection of this manual facilit/ shall 'e '/ means of a
special 7e/# code or tool different from the one specified a'o%e +see 9.*.1 and clause 11<.
Ghen manuall/ operated for maintenance# test purposes and in cases of emer&enc/# the automatic pro&ramme
se>uence shall automaticall/ switch off;
The manual ad%ance s/stem shall not cause a safet/ ha$ard and shall onl/ allow the se>uential selection of one sta&e
at a time;
5;1;9 ( short circuit in an/ component or e>uipment connected directl/ or indirectl/ to the control s/stem shall not
cause dama&e to the control s/stem;
7.1.1( The control s/stem shall not 'e located such that the ma0imum %alues of temperature and humidit/
specified '/ the manufacturer can 'e e0ceeded;
NBTE; Normall/ the temperature and humidit/ in the %icinit/ of the control s/stem should not e0ceed 5< KC and 85 M relati%e humidit/
respecti%el/ +see 1*.9<.
7.1.11 The control s/stem shall ha%e a status indicator for inputs and outputs;
NBTE; This can 'e located within the control ca'inet;
7.1.12 1eans shall 'e pro%ided to ensure that the re>uirement for steam penetration throu&hout the sterili$er
cham'er and sterili$er load is achie%ed durin& each sterili$ation c/cle;
NBTE; The method used can include air detection or anal/sis of time# pressure and temperature;
7.1.1* The safet/ shut down de%ice re>uired '/ EN 61<1<C2C<91 shall compl/ with 1(.7.2 o% EN 6<2<9C1:1992;
5;1;19 Sterili$ers which operate with a plateau period in e0cess of "#5 min shall 'e pro%ided with an automatic c/cle
for the Bowie and ,ic7 Test; This c/cle shall ha%e the same air remo%al sta&e as the sterili$ation c/cle used for
production# e0cept that the plateau period shall 'e limited to the time specified in prEN 865C" for the rele%ant
temperature; This c/cle shall 'e selected '/ means of a special 7e/# tool or code;
5;1;15 *f an automatic test c/cle is pro%ided to carr/ out an air lea7a&e test as specified in clause 2<# the indication
at the end of the c/cle shall 'e different from that of a production sterili$ation c/cle;
5;1;16 Ghere a separate Bowie and ,ic7 c/cle is pro%ided# the Dc/cle completeD indication shall 'e different
from that of a normal sterili$ation c/cle;
7.2 6a.lt in'i-ation s/stem
5;2;1 *f the %alues of c/cle %aria'les are outside the limits specified '/ the manufacturer +see 5;1-# or a failure of a
ser%ice occurs sufficient to pre%ent the attainment of these %aria'les# the automatic controller shall:
a- cause a %isual indication that a fault has occurredJ
NBTE; (dditionall/# an audi'le alarm s/stem which should 'e muta'le can 'e pro%ided;
'- cause a %isual indication of the sta&e of the sterili$ation c/cle at which the fault occurredJ
c- not cause a safet/ ha$ard;
5;2;2 *f the sterili$er is fitted with a printer# the
indication of a fault shall also 'e printed;
5;2;" (fter a fault has 'een indicated# the automatic
controller shall allow the sterili$ation c/cle to 'e
terminated without causin& a safet/ ha$ard; (n/ user
inter%ention shall re>uire the use of a special 7e/# code
or tool; ( %isual displa/ of a fault shall continue at
least until the door loc7in& mechanism is released '/
the use of a special 7e/# code or tool;
NBTE; *t should 'e assumed that the sterili$er load has not 'een su'=ected to the sterili$ation c/cle;
8 1er%orman-e re:.irements
8.1 ?eneral
The manufacturer or supplier shall pro%ide the purchaser with documentar/ e%idence to demonstrate compliance
with the performance re>uirements for the rele%ant tests as detailed in clause 15 and ta'le 9 +see also clauses 25
and 28-;
NBTE 1; The responsi'ilit/ for carr/in& out the installation test should 'e a&reed 'etween supplier and purchaser;
NBTE 2; Not all the tests listed 'elow are re>uired in all situations; 2eference should 'e made to ta'le 9# which identifies the re>uired tests#
8.2 et&alit/ @4i-ro$ial e%%i-a-/<
8.2.1 Small load, biological indicators
Ghen tested in accordance with 15;1# the sterili$ation c/cle shall ensure that e0posed 'iolo&ical indicators are no
lon&er %ia'le when su'=ected to the culture conditions specified '/ the manufacturer of the 'iolo&ical indicator;
@ntreated 'iolo&ical indicators shall 'e %ia'le when cultured in the same manner;
8.2.2 Full load, biological indicators
Ghen tested in accordance with 15;2# the sterili$ation c/cle shall ensure that e0posed 'iolo&ical indicators are no
8.2.* Rubber load, biological indicators
Ghen tested in accordance with 15;"# the sterili$ation c/cle shall ensure that e0posed 'iolo&ical indicators are no
8.* 1&/si-al #arameters
8.*.1 Temperature characteristics 8.*.1.1 Sterilization temperature band
The sterili$ation temperature 'and shall ha%e the lower limit defined '/ the sterili$ation temperature and an upper
limit of F" A;
8.*.1.2 Small load, thermometric
The e>uili'ration time shall not e0ceed 15 s for sterili$er cham'ers with up to 8<<1 usa'le space and "< s for
lar&er sterili$er cham'ers;
,urin& the plateau period# the temperature measured a'o%e a standard test pac7 +see 18.1< shall not e0ceed the
temperature measured at the reference measurement point of the sterili$er cham'er '/ more than 5 A for the first
6< s and 2 A for the remainin& period;
Throu&hout the holdin& time# the temperature measured at the reference measurement point of the sterili$er
cham'er and the temperature measured at the nominal &eometric centre of a standard test pac7 shall:
C 'e within the sterili$ation temperature 'andJ
C not fluctuate '/ more than L 1#5 AJ
C not differ from one another '/ more than 2 A
The holdin& time shall 'e not less than 15 min# 1< min
and " min for sterili$ation temperatures of 121 KC#
126 KC and 1"9 KC respecti%el/;
Compliance shall 'e tested in accordance with 18;1;
8.*.1.* @ull load, thermometric
The e>uili'ration time shall not e0ceed 15 s for sterili$er cham'ers with up to 8<<1 usa'le space and "< s for
lar&er sterili$er cham'ers;
(t the end of the e>uili'ration time# the temperature measured at the reference measurement point of the sterili$er
cham'er and the temperature measured at the nominal &eometric centre and 'elow the top sheet of a standard test
pac7 +see 2).1< located in the test load shall 'e within the sterili$ation temperature 'and;
Throu&hout the holdin& time the temperatures measured in the sterili$er cham'er and in a standard test pac7
located in the test load shall:
C 'e within the sterili$ation temperature 'andJ
C not fluctuate '/ more than L 1#5 AJ
C not differ from one another '/ more than 2 A;
The holdin& time shall 'e not less than 15 min# 1< min
and " min for sterili$ation temperatures of 121 KC#
126 KC and 1"9 KC respecti%el/;
Compliance shall 'e tested in accordance with 18.2. 8.*.2 ir removal and steam penetration
8.*.2.1 'owie and !ic5 test
Ghen the sterili$er is tested as descri'ed in clause 19# the indicator shall show uniform colour chan&e throu&hout
the indicator in accordance with prEN 865C";
8.*.2.2 Air lea5age flow rate
Ghen the sterili$er is tested as descri'ed in clause 2<# the rate of pressure rise shall 'e not &reater than 1#" m'ar8min
+<#1" 7.a8min-;
8.*.2.* Air detector, small load
Ghen tested as descri'ed in 21;1# an air detector shall cause a fault to 'e indicated if the %olume of air or other nonC
condensa'le &ases retained or introduced into the sterili$er cham'er durin& the air remo%al and steam aditiission of
the sterili$ation c/cle causes a difference in temperature 'etween the nominal &eometric centre of a standard test
pac7 +see 2).1< and the temperature measured at the reference measurement point of the sterili$er cham'er of more
than 2 A at the commencement of the e>uili'ration time;
8.*.2.9 Air detector, full load
Ghen tested as descri'ed in 21;2# an air detector shall cause a fault to 'e indicated if the %olume of air or other
nonCcondensa'le &ases retained or introduced into the sterili$er cham'er durin& the air remo%al and steam
admission of the sterili$ation c/cle causes a difference in temperature 'etween the nominal &eometric centre of a
standard test pac7 +see 2).1< and the temperature measured at the reference measurement point of the sterili$er
cham'er of more than 2 A at the commencement of the e>uili'ration time;
8.*.2.5 Air detector function
Ghen the sterili$er is tested as descri'ed in 21;"# the test result shall 'e re&arded as satisfactor/ if a fault is
indicated;
8.9 oa' 'r/ness
8.9.1 !oad dr"ness, small load, te#tiles
Ghen the sterili$er is tested as descri'ed in 22;1# the mass of the test sheets shall not increase '/ more than 1 M;
8.9.2 !oad dr"ness, $ull load, te#tiles
Ghen the sterili$er is tested as descri'ed in 22;2# the mass of the test sheets shall not increase '/ more than 1 M;
8.9.* !oad dr"ness, metal
Ghen the sterili$er is tested as descri'ed in 22;"# the mass of the test load shall not increase '/ more than <#2 M;
9 So.n' #o,er
The manufacturer shall specif/ the mean and the ma0imum sound power le%els &enerated '/ the sterili$er e0pressed
as an (Cwei&hted sound power le%el# calculated as descri'ed in EN *SB "596:1995 and measured as descri'ed in
clause 2" of this standard; The manufacturer shall specif/ an/ additional de%ice# e;&; an air compressor# which is
necessar/ for the operation of the sterili$er and which is installed separatel/ from it; The sound power le%el for
these de%ices shall 'e specified;
No ma0imum %alue of the (Cwei&hted sound power le%el shall e0ceed the mean (Cwei&hted sound power le%el '/
more than 15 dB;
1( Rate o% #ress.re -&an!e
The ma0imum rate of pressure chan&e durin& an/ part of the sterili$ation c/cle shall not e0ceed 1< 'ar8min +1<<<
7.a8min-; Compliance shall 'e tested as descri'ed in clause 25.
NBTE; )i&her pressure chan&e rates than 1< 'ar8min +1<<< 7.a8min- can dama&e the pac7a&e;
11 Sa%et/
Sterili$er pressure %essels and door safet/ de%ices shall compl/ with .art 1 of EN 61<1< and EN 61<1<C2C<91;
12 4ar;in!
12;1 ( Council ,irecti%e on the appro0imation of the laws of the mem'er states concernin& pressure e>uipment
European Standards on pressure e>uipment are pu'lished# the mar7in& of the pressure e>uipment should compl/
with national re&ulations and standards appl/in& in the countr/ of intended use;
12;2 1ar7in&s for safet/ shall compl/ with .art 1 of EN 61<1< and EN 61<1<C2C<91;
12.* Bther mar7in&s shall 'e permanentl/ and le&i'l/ mar7ed and include at least:
C manufacturerDs8supplierDs identificationJ
C uni>ue identification num'erJ
C model identificationJ
C production /ear +not re>uired if this is included in the identification mar7in&s-J
C description of the sterili$er as 'ein& a Nsteam sterili$er for wrapped &oods and porous loadsDJ
C control %al%e identification +see 5.1.9<.
1* Ser8i-e an' lo-al en8ironment
1*.1 ?eneral
NBTE; The performance of a sterili$er is dependent upon its
desi&n and construction# to&ether with the >ualit/ of ser%ices
pro%ided;
Sterili$ers compl/in& with this standard shall operate
with ser%ices meetin& the followin& re>uirements;
1*.2 Ele-tri-al s.##l/
1";2;1 The sterili$er shall 'e desi&ned to operate when the mains %olta&e is in accordance with ,EC "8 +see '-
of 28;2-;
1";2;2 The sterili$er shall 'e desi&ned to operate with an electrical suppl/ which is pro%ided with means to isolate
all poles simultaneousl/ from the mains suppl/; Each pole shall 'e fused separatel/;
1*.* Steam s.##l/ to t&e sterilizer -&am$er
1*.*.1 General
The sterili$er shall 'e desi&ned to operate with a steam suppl/ which is pro%ided with a condensate trap within 2 m
of the connection to the sterili$er;
1*.*.2 %on-condensable gases
The sterili$er shall 'e desi&ned to operate with dr/ saturated steam containin& not more than "#5 M 0A/of nonC
condensa'le &ases when tested as descri'ed in 29;1;
1*.*.* Dr"ness value
The sterili$er shall 'e desi&ned to operate with dr/ saturated steam with a dr/ness %alue not less than <#9 when
tested as descri'ed in 29;2;
NBTE; !or metal loads# the dr/ saturated steam should ha%e a dr/ness %alue not less than <#95;
1*.*.9 Superheat
The de&rees of superheat measured in free steam at atmospheric pressure shall not e0ceed 25 A Compliance shall
'e tested as descri'ed in 29.*.
NBTE# This %alue can 'e chan&ed durin& the re%ision of this standard;
1*.*.5 &ontaminants
The sterili$er shall 'e desi&ned to operate with steam which# on condensin&# does not contain contaminants in
sufficient >uantit/ to impair the sterili$ation process or harm the sterili$er or sterili$ed load;
NBTE 1; Su&&ested ma0imum %alues of some contaminants are &i%en in ta'le B;*;
NBTE 2; ( method for o'tainin& a condensate sample is &i%en in clause 29.9.
1*.*.) Pressure $luctuation
The sterili$er shall 'e desi&ned to operate with a pressure fluctuation not e0ceedin& L 1< M of the nominal &au&e
pressure measured at the inlet to the final pressure reduction %alue;
1*.*.7 Feed 'ater
The sterili$er shall 'e desi&ned to operate with steam produced from water free from contaminants in a
concentration that can impair the sterili$ation process or harm the sterili$er or sterili$ed load;
NBTE; Su&&ested ma0imum %alues of some contaminants are &i%en in ta'le B;*;
1*.9 Aater
The sterili$er shall 'e desi&ned to operate with water which is of pota'le >ualit/ and supplied at a temperature not
e0ceedin& 15 KC;
NBTE 1; The temperature of water should 'e as low as possi'le 'ecause of the effect of temperature on the performance of the %acuum
s/stem; )i&her water temperatures can modif/ the specified %acuum le%els#
NBTE 2; The hardness %alue of water# S +ions of al7aline earth-# should 'e 'etween <#5 mmol81 and 2#< mmol8 )ardness %alues outside these
limits can cause scalin& and corrosion pro'lems;
NBTE "; National re&ulations can re>uire a 'ac7fiow protection de%ice to 'e fitted;
1*.5 "om#resse' air
The sterili$er shall 'e desi&ned to operate with a compressed air suppl/ at a pressure of 5 'ar to 5 'ar +5<< 7.a to
5<< 7.a-# free of li>uid water# filtered to 25 +0m and free from oil droplets &reater than 2 f0m +see e- of 28;2-;
1*.) Ele-troma!neti- inter%eren-e
The immunit/ of the sterili$er to electroma&netic interference shall compl/ with .art 1 or .art 2 of EN 5<<82#
as appropriate;
The emission of electroma&netic interference from the sterili$er shall compl/ with .art 1 or .art 2 of EN 5<<81# as
appropriate;
The supplier shall state with which of these .arts of EN 5<<81 and EN 5<<82 the sterili$er complies +see o- of 28;2-;
1*.7 Drains
The sterili$er shall 'e desi&ned to operate with a draina&e s/stem resistant to water at 1<< KC# and 'e capa'le of
passin& the ma0imum flow rate of water# air and condensed steam;
NBTE; National re&ulations can re>uire the drain 'e trapped and %ented and not connected to other drains which can cause a 'ac7 pressure
or o'struction to flow; (n air 'rea7 can also 'e necessar/;
1*.8 S.##ortin! s.r%a-e @%loors<
The sterili$er shall 'e desi&ned to operate when installed on a surface which is hori$ontal within the tolerance limits
specified in ta'les 1 and 2 +see 9;9-# and which will support the ma0imum floor loadin& specified '/ the
manufacturer +see 28;2-;
NBTE; The floor should 'e imper%ious to water and ade>uate for collectin& or drainin& water spilla&e from the sterili$er;
1*.9 En8ironment
The sterili$er shall 'e desi&ned to operate in an am'ient temperature and humidit/ up to "5 KC and 85 M relati%e
humidit/ respecti%el/;
NBTE; This can re>uire the pro%ision of a %entilation s/stem desi&ned and constructed to remo%e the heat transmitted from the sterili$er and
from the sterili$ed load durin& unloadin& +see ).1.1 and 5;1-;
1*.1( Ser8i-e -onne-tions
The sterili$er shall 'e desi&ned to operate with all ser%ice connections for fluids +e;&; water# steam# compressed air-
pro%ided with an isolatin& %al%e and terminatin& in accordance with the manufacturerDs sterili$er specification;
19 Installation -&e-;s
NBTE; *nstallation chec7s precede the installation test and are carried out to esta'lish that:
C the sterili$er has 'een pro%ided and installed correctl/J
C the sterili$er is safe to operateJ
C the sterili$er does not interfere with near'/ e>uipmentJ
C all connected ser%ices are satisfactor/;
The installation chec7s shall confirm that
a- e0cept for the results of the installation tests# the documentation specified in clause 25 and the information
specified in 28;2 ha%e 'een pro%idedJ
'- safet/ s/stems and de%ices are in compliance with .art 1 of EN 61<1< and EN 61<1<C2C<91J
c- when the sterili$er is operated with an empt/ sterili$er cham'er# the pressure and temperature of each
connected ser%ice is within the ran&e specified '/ the manufacturer and there are no lea7s of steam# compressed
air# water or effluent durin& an/ part of the sterili$ation c/cleJ
d- durin& an/ test or chec7 there is no e%idence of electroma&netic interference to or from ad=acent e>uipment
+see 1*.)<B
e- the cali'ration of temperature and pressure instruments has 'een chec7ed at the nominal sterili$ation
temperature and pressure and that the/ compl/ with ).2.1.*5 ).2.2.15 ).2.2525 ).*.2.25
).*.2.*5 ).*.*.1 an' ).*.*.2.
15 "ate!ories o% tests
15.1 T"pe test
15;1;1 The series of tests listed in ta'le 9 and descri'ed in clauses 15 to 25 shall 'e carried out as t/pe tests;
15;1;2 Sterili$ers classed as the same t/pe shall ha%e:
a- the same num'er of doors in the same confi&urationJ
'- all ser%ice connections into the sterili$er cham'er in the same orientationJ
NBTE 1; ( mirror ima&e of the ori&inal orientation does not constitute a new t/pe;
c- the same control s/stem with all sensors located in the same position and orientationJ
NBTE 2; Ghere a chan&e+s- in the control s/stem does not affect the operation of the sterili$ation c/cle# the tests descri'ed in 17.15 17.2 and
15;" can 'e omitted in further t/pe tests;
d- the same sterili$ation c/cle;
Ghene%er the desi&ned operatin& characteristics of the air remo%al sta&e of the sterili$ation c/cle are chan&ed# all the
tests e0cept the tests accordin& to 17.15 17.2 and 15;" shall 'e carried out
15.1.* *f all other aspects of desi&n remain the same# the followin& %ariations shall not constitute a new t/pe:
a- hei&ht of sterili$er cham'er location a'o%e the floorJ
'- differences in the dimensions of the sterili$er cham'er not &reater than L 1< M of the dimensions with
con&ruent sterili$er cham'er shapesJ
c- increasin& the time of the plateau period within the sterili$ation c/cle ha%in& the same sterili$ation temperature
and the same air remo%al sta&eJ
d- an/ chan&e of the desi&n or pro%enance of e>uipment# pro%idin& there is a%aila'le documented e%idence of
%alidation of the desi&n chan&e to show there is no ad%erse effect on the performance of the sterili$er which would
affect compliance with this standard;
NBTE; !or documented e%idence of %alidation of the desi&n chan&e see 9.9.) of EN *SB 9<<1: 1999;
Chan&es or modification of e>uipment pre%iousl/ identified as not contri'utin& more than " dB+(- to the total sound
power le%el shall not re>uire a repeat of the sound power test descri'ed in clause 2";
15.2 Aor;s tests
The series of tests listed in ta'le 9 and descri'ed in clauses 15 to 25 shall 'e carried out as wor7s tests;
15.* Installation test
The series of tests listed in ta'le 9 and descri'ed in clauses 15 to 25 shall 'e carried out as installation tests;
NBTE 1; 2esponsi'ilit/ for carr/in& out these tests should 'e a&reed 'etween the manufacturer# supplier and purchaser;
NBTE 2; (dditional tests can 'e re>uired '/ a&reement 'etween the manufacturer or supplier and the purchaser;
1) Test #ro!rammes
16;1 !or acceptance of the sterili$er each test in the a&reed test pro&ramme +see ta'le 9- shall 'e successfull/
completed in accordance with the re>uirements specified in this standard;
16;2 *f ad=ustment is made to the sterili$er durin& the test se>uence such that the c/cle %aria'les of the sterili$ation
c/cle are affected# the test pro&ramme shall 'e repeated;
16;" 2eproduci'ilit/ of the t/pe test shall 'e demonstrated '/ three successi%e repetitions of each specified test;
16;9 Before carr/in& out the installation tests# the result of the installation chec7s +see clause 19- shall 'e
accepta'le;
Ta'le 9; Test pro&rammes
Test 2e>uirement Test method T/pe test Gor7s test *nstallation test
accordin& to accordin& to
1icro'iolo&ical tests
C Small load
1
- 8;2;1 15;1
I
B B
C!ull load
1
- 8;2;2 15;2 I B B
C 2u''er load
1
- 8;2;" 15;" I B B
Thermometric tests
C Small load 8;";1;2 18;1 I B I
C !ull load 8;";1;" 18;2 I B I
(ir remo%al and
steam penetration
C Bowie and ,ic7 8;";2;1 19 I I I
test
C (ir lea7a&e 8;";2#2 2< I I I
C (ir detector# 8;";2;" 21;1 I I I
small load
"
-
C (ir detector# 8;";2;9 21;2 I < B
full load
"
-
C (ir detector 8;";2;5 21;" I I I
function
"
-
oad dr/ness tests
C Small load# 8;9;1 22;1 I B B
te0tiles
C !ull load# 8;9;2 22;2 I B I
te0tiles
C 1etal load
2
- 8;9;" 22;" I B B
Sound power 9 2" I n n
,/namic cham'er 1< 25 I B B
pressure
Steam >ualit/ tests
C NonCcondensa'le 1";";2 29;1 B B B
&ases
C ,r/ness %alue 1";";" 29;2 B B B
C Superheat 1";";9 29;" B B B
I C /es B T optional n T no
I-
2e>uired when ru''er loads are included in the sterili$ation c/cle;
2-
2e>uired when metal loads are included in the sterili$ation c/cle;
/ 2e>uired when air detector is fitted;
17 4i-ro$iolo!i-al tests
17.1 Small loa'5 $iolo!i-al in'i-ators
NBTE; The small load test# 'iolo&ical indicators# is intended to show that when connected ser%ices compl/ with the re>uirements specified
in this standard# and the times# temperatures and pressures which control the sterili$ation c/cle are set at the le%els at which compliance with
the re>uirements for the small load# thermometric test has 'een demonstrated# reco%er/ of test or&anisms from the 'iolo&ical indicator
placed in the test load cannot 'e o'tained after the completion of a sterili$ation c/cle;
17.1.1 pparatus
15;1;1;1 Standard test pac7 as descri'ed in 2).1.
15;1;1;2 Si0 'iolo&ical indicators in accordance with prEN 866C";
15;1;1;" Connected ser%ices compl/in& with clause 1*.
17.1.2 Procedure
,imensions in millimetres 1 Centre
6i!.re 5. o-ation o% $iolo!i-al in'i-ators
15;1;2;1Carr/ out an air lea7a&e test as descri'ed in clause 2<; ,o not proceed if the air lea7a&e flow rate e0ceeds
that specified in 8.*.2.2.
15;1;2;2Select the sterili$ation c/cle to 'e tested;
15;1;2;" Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
15;1;2;92emo%e the wrappin& from the standard test pac7 and place fi%e 'iolo&ical indicators on the %ertical
&eometric a0is as shown in fi&ure 5; 2eassem'le and secure as descri'ed in 26;1;
17.1.2.5 .lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le space#
supported at a distance of 'etween 1<< mm and 2<< mm a'o%e the cham'er 'ase;
!or sterili$ers of one sterili$ation module the method shall 'e modified such that the standard test pac7 is supported
a'o%e the 'ase of the sterili$er cham'er;
17.1.2.) Carr/ out a sterili$ation c/cle and ta7e the followin& measurements;
C B'ser%e and record the time ta7en# num'er of pulses# temperatures and pressures and le%els of %acuum at all
si&nificant parts of the sterili$ation c/cle# e;&; the chan&e from each sta&e or su'sta&e;
C (t the 'e&innin&# end and middle of the holdin& time# o'ser%e and record the sterili$er cham'er temperature and
sterili$er cham'er pressure;
C Ensure that a recordin& of the sterili$ation c/cle is made '/ the recordin& instrument fitted permanentl/ to the
sterili$er +see ).*<.
17.1.2.7 (t the completion of the test# proceed as follows:
C Chec7 that a %isual displa/ of Dc/cle complete is o'tained
C Culture the si0 'iolo&ical indicators in accordance with the instructions &i%en '/ the manufacturer of the
'iolo&ical indicators; E0amine the fi%e e0posed 'iolo&ical indicators for compliance with 8;2;1; The untreated
'iolo&ical indicator shall 'e demonstrated as 'ein& %ia'le or the test shall 'e re&arded as not %alid and shall 'e
repeated;
C E0amine the records specified a'o%e for compliance with the sterili$ation c/cle specification;
17.2 6.ll loa'5 $iolo!i-al in'i-ators
NBTE; The full load test# 'iolo&ical indicators# is used to demonstrate that# at the le%els at which controls are set# test or&anisms placed in a
standard test pac7 located in a load of specified ma0imum mass and of sufficient si$e to fill the usa'le space cannot 'e reco%ered after 'ein&
su'=ected to a sterili$ation c/cle;
17.2.1 pparatus
15;2;1;1!ull load# te0tiles as descri'ed in 26;6;
15;2;1;2Si0 'iolo&ical indicators in accordance with prEN 866C";
15;2;1;" Connected ser%ices compl/in& with clause 1*.
17.2.2 Procedure
17.2.2.1 Carr/ out an air lea7a&e test as descri'ed in clause 2<; ,o not proceed if the air lea7a&e flow rate e0ceeds
15;2;2;2Select the sterili$ation c/cle to 'e tested;
15;2;2;" Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
15;2;2;9 2emo%e the wrappin& from the standard test pac7 and place fi%e 'iolo&ical indicators on the %ertical
&eometric a0is as shown in fi&ure 5; 2eassem'le and secure as descri'ed in 26;1;
15;2;2;5.lace the standard test pac7 and stac7s of sheets comprisin& the test sterili$er load into the usa'le space as
descri'ed in 26;6;
15;2;2;6 Carr/ out a sterili$ation c/cle and ta7e the followin& measurements;
C (t the 'e&innin&# middle and end of the holdin& time# o'ser%e and record the sterili$er cham'er temperature
and sterili$er cham'er pressure;
17.2.2.7 (t the completion of the test# proceed as follows;
C Chec7 that a %isual displa/ of Dc/cle completeD is o'tained;
C Culture the si0 'iolo&ical indicators in accordance with the instructions &i%en '/ the manufacturer of the
'iolo&ical indicators; E0amine the fi%e e0posed 'iolo&ical indicators for compliance with 8;2;2; The untreated
repeated;
17.* R.$$er loa'5 $iolo!i-al in'i-ators
NBTE; The ru''er load test# 'iolo&ical indicators# is used to demonstrate that# at the le%els at which controls are set# test or&anisms
inserted inside a len&th of ru''er tu'in&# placed into a test pac7 located in a load of si$e sufficient to fill the usa'le space cannot 'e
reco%ered after 'ein& su'=ected to a sterili$ation c/cle;
17.*.1 pparatus
15;";1;1 Test pac7# ru''er# as descri'ed in 26;5;
15;";1;2 Natural ru''er o'=ects sufficient to fill the usa'le space and capa'le of withstandin& dr/ saturated steam at
temperatures up to a ma0imum of 126 KC;
15;";1;" Bas7ets# each e>ui%alent in si$e to one sterili$ation module;
15;";1;9 Bne 'iolo&ical indicator from the same 'atch as those used to form the test pac7a&es descri'ed
in 2).7.
17.*.1.5 Connected ser%ices compl/in& with clause 1";
17.*.1.) Stop watch with an error of not more than : <#5 s o%er a period of 15 min;
17.*.2 Procedure
15;";2;1 Carr/ out an air lea7a&e test as descri'ed in clause 2<; ,o not proceed if the air lea7a&e flow rate e0ceeds
15;";2;2 Select the sterili$ation c/cle to 'e tested;
15;";2;" Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
15;";2;9Bpen the sterili$er door and start the stopwatch;
15;";2;5 ea%e the sterili$er door open for a period of at least "< min;
15;";2;6 .lace the test pac7# ru''er# in position in the usa'le space identified '/ the manufacturer as the most
difficult to sterili$e; !ill the remainder of the usa'le space with 'as7ets# each containin& appro0imatel/ 2#2 7& of
natural ru''er o'=ects;
15;";2;5 Carr/ out a sterili$ation c/cle and ta7e the followin& measurements;
C B'ser%e and record the time ta7en# num'er of pulses# temperatures and pressures and le%els of
%acuum at all si&nificant parts of the sterili$ation c/cle# e;&; the chan&e from each sta&e or su'sta&e;
C (t the 'e&innin&# middle and end of the holdin& time# o'ser%e and record the sterili$er cham'er
temperature and sterili$er cham'er pressure;
C Ensure that a recordin& of the sterili$ation c/cle is made '/ the recordin& instrument fitted permanentl/
to the sterili$er +see ).*<.
17.*.2.8 (t the completion of the test# proceed as follows;
C Culture the 1< 'iolo&ical indicators in accordance with the instructions &i%en '/ the manufacturer of the
'iolo&ical indicators; E0amine the nine e0posed 'iolo&ical indicators for compliance with 8;2#"; The untreated
repeated;
18 T&ermometri- tests
18.1 Small loa'5 t&ermometri-
NBTE; The small load test# thermometric is used to demonstrate that# after the air remo%al sta&e of the sterili$ation c/cle# sterili$in&
conditions are o'tained within the sterili$er cham'er and standard test pac7; The standard test pac7 is chosen to represent the ma0imum
densit/ of porous load material which a sterili$er conformin& to this standard is desi&ned to process; The more air there is to remo%e# the
more e0actin& will 'e the testJ that is wh/ this pac7 is used '/ itself in an otherwise empt/ sterili$er cham'er;
18.1.1 pparatus
18;1;1;1 Standard test pac7 as descri'ed in 26;1;
18;1;1;2 Thermometric recordin& instrument as descri'ed in 26;9;
18;1;1;" Three temperature sensors as descri'ed in 26;";
18;1;1;9 Connection fittin& with a pipe thread *SB 228C31( throu&h which the temperature sensors can 'e introduced
into the sterili$er cham'er without affectin& its %acuumCti&htness and pressureCti&htness +see fi&ure 6-;
18.1.1.5 Connected ser%ices compl/in& with clause 1*.
18.1.2 Procedure
18;1;2;1 *ntroduce the temperature sensors into the sterili$er cham'er throu&h the temperature sensor entr/
connection and fittin&;
18;1;2;2 Carr/ out an air lea7a&e test as descri'ed in clause 2<; ,o not proceed if the air lea7a&e flow rate e0ceeds
18;1;2;" .lace one of the temperature sensors either in the acti%e drain to a depth of at least 1< mm or at the
reference measurement point;
18.1.2.9 Select the sterili$ation c/cle to 'e tested;
18;1;2;5Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
18;1;2;62emo%e the wrappin& from the standard test pac7 and place one temperature sensor at the nominal
&eometric centre of the standard test pac7; 2eassem'le and secure as descri'ed in 26;1;
18;1;2;5 .lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le
space# supported at a distance of
'etween 1<< mm and 2<< mm a'o%e the cham'er 'ase;
!or sterili$ers of one sterili$ation module# the method shall 'e modified such that the standard test pac7 is
supported a'o%e the 'ase of the sterili$er cham'er;
18.1.2.8Secure the third temperature sensor 5< mm a'o%e the upper surface of the test pac7 and on its nominal
%ertical centre; !or sterili$ers of one sterili$ation module# the method shall 'e modified such that the standard test
pac7 is supported a'o%e the 'ase of the sterili$er cham'er and the third temperature sensor is located in the usa'le
cham'er space within 5< mm o%er the standard test pac7;
18.1.2.9Carr/ out a sterili$ation c/cle and ta7e the followin& measurements;
si&nificant parts of the sterili$ation e;&; the chan&e from each sta&e or su'sta&e;
C (t the 'e&innin&# middle and end of the holdin& time# o'ser%e and record the sterili$er cham'er temperature
and sterili$er cham'er pressure;
18.1.2.1( Bn completion of the test# proceed as follows;
C Chec7 that a %isual displa/ of Dc/cle complete is o'tained
C E0amine the records for compliance with the performance re>uirements specified in 8.*.1.2.
18.2 6.ll loa'5 t&ermometri-
NBTE; The full load test# thermometric is used to demonstrate that# at the le%els at which the controls are set# the re>uired sterili$in&
conditions will 'e produced in a test load of specified ma0imum mass and of sufficient si$e to fill the usa'le space;
18.2.1 pparatus
18;2;1;1 !ull load# te0tiles# as descri'ed in 26;6;
18;2;1;2 Thermometric recordin& instrument as descri'ed in 26;9;
18;2;1;"Three temperature sensors as descri'ed in 26;";
18;2;1;9Connection fittin& with a pipe thread
*SB 228C31( throu&h which the temperature sensors can 'e introduced into the sterili$er cham'er without affectin&
its %acuumCti&htness and pressureCti&htness +see fi&ure 6-;
18.2.1.5Connected ser%ices compl/in& with clause 1";
18.2.2 Procedure
18;2;2;1 *ntroduce the temperature sensors into the sterili$er cham'er throu&h the temperature sensor entr/
18;2;2;" .lace one of the temperature sensors either into the acti%e drain to a depth of at least 1< mm or at the
reference measurement point
18;2;2;9 Select the sterili$ation c/cle to 'e tested;
18;2;2;5 Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
18;2;2;6 2emo%e the wrappin& from the standard test pac7 and place one temperature sensor at the nominal
&eometric centre and one 'elow the top sheet; 2eassem'le and secure as descri'ed in 26;1;
18;2;2;5 .lace the standard test pac7 and stac7s of sheets comprisin& the test sterili$er load into the usa'le space as
descri'ed in 26;6;
18;2;2;8 Carr/ out a sterili$ation c/cle and ta7e the followin& measurements;
C (t the 'e&innin&# middle and end of the holdin& time# o'ser%e and record the sterili$er cham'er temperature and
sterili$er cham'er pressure;
18.2.2.9 (t the completion of the test# proceed as follows;
C E0amine the records and sheets comprisin& the standard test pac7 for compliance with the performance
re>uirements specified in 8.*.1.*.
19 Bo,ie an' Di-; test
NBTE; The Bowie and ,ic7 test was concei%ed as a test for successful air remo%al for soCcalled hi&hC%acuum porous load sterili$ers; (
successful Bowie and ,ic7 test indicates rapid and e%en penetration of steam into the test pac7; 2etention of air within the pac7 due to:
C an inefficient air remo%al sta&eJ
C the presence of an air lea7 durin& the air remo%al sta&eJ
; D C the presence of nonCcondensa'le &ases in the steam suppl/J
are circumstances which can lead to failure of the test
The result of the test can also 'e affected '/ other factors which inhi'it steam penetration; ( failure of the test is therefore not conclusi%e
proof that a fault is due to air retention# air lea7a&e or nonCcondensa'le &ases# and other causes of failure ma/ need to 'e eliminated;
19.1 A##arat.s
19;1;1 Standard test pac7 as descri'ed in 2).1.
19;1;2 *ndicator in accordance with prEN 865C";
19;1;" Connected ser%ices compl/in& with clause 1*.
19.2 1ro-e'.re
19;2;1 Select the sterili$ation c/cle to 'e tested +see 7.1.19<.
19;2;2 Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/ and without an/ e0tended dr/in& time;
19;2;" 2emo%e the wrappin& from the standard test pac7 and place the indicator in the sheet located in the
appro0imate centre of the standard test pac7;
2eassem'le and secure as descri'ed in 26;1;
19;2;9 .lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le space
supported at a distance of 'etween 1<< mm
and 2<< mm a'o%e the cham'er 'ase;
19;2;5 Carr/ out a sterili$ation c/cle in accordance with the manufacturerDs operatin& procedure;
19;2;6 (t the end of the test e0amine the indicator for compliance with the re>uirement specified in 8.*.2.1.
2( Air lea;a!e test
NBTE; )ie air lea7a&e test is used to demonstrate that the >uantit/ of air lea7a&e into the sterili$er cham'er durin& the periods of %acuum
does not e0ceed a le%el which will inhi'it the penetration of steam into the sterili$er load and will not 'e a potential ris7 to the reC
contamination of the sterili$er load durin& dr/in&;
2(.1 A##arat.s
2(.1.1 Test pressure &au&e +< m'ar to 16< m'ar- as descri'ed in 26;2;
*f the sterili$er is fitted with an a'solute pressure instrument compl/in& with 26;2 this additional &au&e is not
re>uired;
2<;1;2 Stopwatch# with an error of not more than i <#5 s o%er a period of 15 min;
2<;1;" Connected ser%ices compl/in& with clause 1*.
2(.2 1ro-e'.re
2<;2;1 Connect the test pressure &au&e to the sterili$er cham'er with a means to protect it from a &au&e pressure
of 2#8 'ar +28< 7.a- if it is not desi&ned to operate up to 2#8 'ar +28< 7.a-;
2<;2;2 Sta'ili$e the temperature of the sterili$er cham'er +see note- '/ carr/in& out one of the followin&:
C if the pressure %essel incorporates a heated =ac7et# carr/ out a sterili$ation c/cle with the sterili$er cham'er
empt/J
C if the pressure %essel does not incorporate a heated =ac7et# ensure that the temperature of the sterili$er cham'er
is not more than 2< A from am'ient
NBTE; (s an e0ample# in a closed %essel at 9< m'ar a'solute pressure +9 7.a-# the pressure chan&es '/ appro0imatel/ 1 m'ar +<#1 7.a- for
each 1< A chan&e in temperature# o%er the ran&e 2< KC to 19< KCJ at 5< m'ar +5 7.a- the chan&e is appro0imatel/ 2 m'ar +<#2 7.a-; The test
can 'e compromised if the temperature chan&es '/ more than 1< A durin& the period in which the cham'er pressure is monitored;
2(.2.* Gith the temperature sta'ili$ed and the sterili$er cham'er empt/ e0cept for fi0ed furniture and necessar/
monitorin& sensors# start the test c/cle; Ghen the pressure in the sterili$er cham'er is 5< m'ar a'solute +5 7.a- or
'elow# close all the %al%es connected to the sterili$er cham'er and stop the %acuum pump; B'ser%e and record the
time (ti) and the a'solute pressure +pi-; Gait for at least +"<< L 1<- s to allow e%aporation of condensation in the
cham'er and then o'ser%e and record the a'solute pressure (&8) in the sterili$er cham'er and the time +S2-; (fter a
further +6<< L 1<- s# a&ain o'ser%e and record the a'solute pressure (p>) and the time +M-;
NBTE; The sterili$er can 'e fitted with a test c/cle for air lea7a&e which will carr/ out this procedure automaticall/ and displa/ the air
lea7a&e in m'ar8min#
2(.2.9 (t the end of the test calculate the rate of pressure rise for the 6<< s period and chec7 for compliance
with 8.*.2.2.
NBTE; *f the %alue of +U2 C .i- is &reater than 2< m'ar +2 7.a-# this can 'e due to the initial presence of e0cessi%e condensate in the sterili$er
cham'er;
21 Air 'ete-tor tests
NBTE; (n air detector can 'e fitted to a sterili$er and used to determine whether the nonCcondensa'le &ases contained in the steam
deli%ered to the sterili$er and the air remainin& after the air remo%al sta&e of the sterili$ation c/cle are sufficient to cause the sterili$in&
process to 'e of uncertain efficac/;
21.1 Air 'ete-tor5 small loa'
21.1.1 pparatus
21;1;1;2Thermometric recordin& instrument as descri'ed in 26;9;
21;1;1;" (wo temperature sensors as descri'ed in 2).*.
21;1;1;9Connection fittin& with a pipe thread
21;1;1;51eterin& de%ice as descri'ed in 2).9.
21;1;1;6Test pressure &au&e +< m'ar to 16< m'ar- as descri'ed in 26;2;
21;1;1;5Connected ser%ices compl/in& with clause 1";
21.1.2 Procedure
21;1;2;1 Connect the meterin& de%ice to the sterili$er cham'er usin& the %al%ed port pro%ided '/ the manufacturer;
21;1;2;2 Connect the test pressure &au&e to the sterili$er cham'er with a means to protect it from a &au&e pressure
21;1;2;" *ntroduce the two temperature sensors into the sterili$er cham'er throu&h the temperature sensor entr/
21;1;2;5 .lace one of the temperature sensors either into the acti%e drain in contact with the condensate to a depth
of at least 1< mm or at the reference measurement point;
21;1;2;6 Select the sterili$ation c/cle to 'e tested
21;1;2;8 2emo%e the wrappin& from the standard test pac7 and place the other temperature sensor at the nominal
&eometric centre of the standard test pac7; 2eassem'le and secure as descri'ed in 26;1;
21.1.2.9 .lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le
space# supported at a distance of
'etween 1<< mm and 2<< mm a'o%e the sterili$er cham'er 'ase;
21.1.2.1( Carr/ out a sterili$ation c/cle# 'ut durin& the air remo%al sta&e admit air to the sterili$er cham'er '/
means of the meterin& de%ice; Control the rate of entr/ of the air so that# at the start of the plateau period# the
temperature measured at the centre of the standard test pac7 is not more than 2 A lower than the temperature
measured in the acti%e drain or at the reference measurement point;
NBTE; *t can 'e necessar/ to conduct a num'er of tests in order to esta'lish the air lea7a&e re>uired;
21;1;2;11 Carr/ out a further air lea7a&e test as descri'ed in clause 2< and then calculate the air lea7a&e flow
rate;
21;1;2;12 *f the air lea7a&e causes the sterili$er cham'er pressure to rise more than 11 m'ar8min
+1#1 7.a8min-# reCad=ust the meterin& de%ice to cause a pressure rise of +1< L 1- m'ar8min V+1#< L <#1- 7.a8minE;
21.1.2.1* Carr/ out a sterili$ation c/cle and chec7 that a fault is indicated either durin& or at the end of the
NBTE; To facilitate su'se>uent reCtestin& it is ad%isa'le to record the settin& of the meterin& de%ice at which the air detector causes a fault
to 'e indicated;
21.2 Air 'ete-tor5 %.ll loa'
21.2.1 pparatus
21;2;1;1 !ull load# te0tiles as descri'ed in 26;6;
21;2;1;2 Therniometric recordin& instrument as descri'ed in 26;9;
21;2;1;" Two temperature sensors as descri'ed in 26;";
21;2;1;9 Connection fittin& with a pipe thread
21;2;1;5 1eterin& de%ice as descri'ed in 26;9;
21;2;1;6 Test pressure &au&e +< m'ar to 16< m'ar- as descri'ed in 2).2.
21;2;1;5 Connected ser%ices compl/in& with clause 1*.
21.2.2 Procedure
21.2.2.1 Ensure that the sterili$er complies with the re>uirements for the air detector test# small load +see 8.*.2.*<.
21;2;2;2 Connect the meterin& de%ice to the sterili$er cham'er usin& the %al%ed port pro%ided '/ the manufacturer;
21;2;2;"Connect the test pressure &au&e to the sterili$er e=iam'er with a means to protect it from a &au&e pressure
21;2;2;9 *ntroduce the two temperature sensors into the sterili$er cham'er throu&h the temperature sensor entr/
21;2;2;6 .lace one of the temperature sensors either in the acti%e drain to a depth of at least 1< mm or at the
reference measurement point;
21;2;2;9 2emo%e the wrappin& from the standard test pac7 and place the other temperature sensor at the nominal
&eometric centre of the standard test pac7;
2eassem'le and secure as descri'ed in 26;1;
21;2;2;1< .lace the standard test pac7 as part of the
full load in the sterili$er cham'er as descri'ed in 26;6;
21;2;2;11 Carr/ out a sterili$ation c/cle 'ut durin& the air remo%al sta&e admit air to the sterili$er cham'er '/ means
of the meterin& de%ice; Control the rate of entr/ of air so that# at the start of the plateau period# the temperature
measured at the centre of the standard
test pac7 is not more than 2 A lower than the temperature measured in the acti%e drain or at the reference
measurement point;
NBTE; *t can 'e necessar/ to conduct a num'er of tests in order to esta'lish the air lea7a&e re>uired;
21;2;2;12 Carr/ out a further air lea7a&e test as descri'ed in clause 2< and then calculate the air lea7a&e flow
rate;
21;2;2;1" *f the air lea7a&e causes the sterili$er cham'er pressure to rise more than 11 m'ar8min
+1#1 7.a8min-# reCad=ust the meterin& de%ice to cause a pressure rise of +1< L 1- m'ar8min V+1#< L <#1- 7.a8min=;
21.2.2.19 Carr/ out a sterili$ation c/cle and chec7 that the air detector causes a fault to 'e indicated either durin&
or at the end of the test c/cle;
NBTE; To facilitate su'se>uent reCtestin& it is ad%isa'le to record the settin& of the meterin& de%ice at which the air detector causes a fault to
'e indicated#
21.* Air 'ete-tor %.n-tion
NBTE; The air detector function test is used to pro%ide assurance that the settin& of the air detector remains %alid;
21.*.1 pparatus
21.*.1.1 Standard test pac7 as descri'ed in 2).1.
21;";1;21eterin& de%ice as descri'ed in 26;9;
21;";1;" Connected ser%ices compl/in& with clause 1*.
21.*.2 Procedure
21;";2;1 *f a meterin& de%ice is not alread/ connected# connect one to the sterili$er cham'er usin& the %al%ed port
pro%ided '/ the manufacturer;
21;";2;2 Carr/ out an air lea7a&e test as descri'ed in clause 2<; ,o not proceed if the air lea7a&e flow rate e0ceeds
21;";2;" Select the sterili$ation c/cle to 'e tested;
21;";2;9 Carr/ out a sterili$ation c/cle with the sterili$er cham'er empt/;
21;";2;5 Bpen the %al%e on the port desi&nated '/ the manufacturer;
21;";2;6 Set the meterin& de%ice to the settin& determined durin& the air detector test +see 21.1<.
21;";2;5.lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le space
supported at a distance of
21;";2;8 Carr/ out a sterili$ation c/cle;
21;";2;9 (t the end of the sterili$ation c/cle chec7 for compliance with the re>uirement specified in 8.*.2.5.
21.*.2.1( Close the %al%e on the port desi&nated '/ the manufacturer;
22 oa' 'r/ness tests
22.1 oa' 'r/ness5 small loa'5 te7tiles
NBTE# The load dr/ness test# small load te0tiles# is used to demonstrate that the sterili$ation c/cle without e0tended dr/in& will not cause an
increase in moisture in a standard test pac7 sufficient for there to 'e uncertaint/ in the dr/ness of sterili$er loads routinel/ sterili$ed;
22.1.1 pparatus
22;1;1;2 .ol/eth/lene 'a&s# three# "5< mm I 25< mm or lar&er# manufactured from pol/eth/lene sheet with a thic7ness
not less than 25< =uim;
22;1;1;" Balance# capa'le of wei&hin& a load of at least 1 7& and with an accurac/ of at least C <#1 &;
22;1;1;9 *ndeli'le mar7er;
22;1;1;5 Stopwatch;
22;1;1;6 Connected ser%ices compl/in& with clause 1*.
22.1.2 Procedure
22.1.2.1 (llow the sheets of the standard test pac7 to e>uili'rate# as descri'ed in 26;1;
22.1.2.2 1ar7 three of the sheets of the standard test pac7 and similarl/ mar7 each of the pol/eth/lene 'a&s so
that all are indi%iduall/ identified;
22;1;2;"Gei&h each of the pol/eth/lene 'a&s +mi-;
22;1;2;9.lace one of the mar7ed sheets in each of the 'a&s# wei&h each 'a& and record its mass (m>)
22;1;2;5 2emo%e the sheets from the 'a&s and replace them in the standard test pac7J place one in the centre and
one in the second sheet from either end of the standard test pac7; Secure the standard test pac7 as descri'ed in
26;1;
22;1;2;5 Carr/ out the c/cle to 'e tested with the sterili$er cham'er empt/;
22;1;2;8.lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le space
'etween 1<< mm and 2<< mm a'o%e the cham'er 'ase;
Carr/ out a sterili$ation c/cle; Start the sterili$ation c/cle within 6< s of placin& the test pac7 in the sterili$er
cham'er;
22.1.2.9 (t the completion of the sterili$ation c/cle# and after not more than 6< s# remo%e the standard test pac7
from the sterili$er cham'er; 2emo%e the three mar7ed sheets from the standard test pac7 and immediatel/ transfer
them to their appropriate 'a&s;
Seal each 'a& '/ turnin& its open end o%er se%eral times; Ensure that the total time ta7en from the end of the
sterili$ation c/cle to the enclosure of the sheets does not e0ceed 18< s;
NBTE; The transfer of the sheets to the pol/eth/lene 'a&s should 'e accomplished with the &reatest possi'le econom/ of mo%ement in order
to minimi$e loss of retained moisture;
22;1;2;1< Gei&h and record the mass +R"- of each
sheet in its 'a&;
22;1;2;11 Calculate the chan&e in moisture content +in per cent- of each sheet usin& the formula:
where
m
1
is the mass of the pol/eth/lene 'a&# in &ramsJ
ni8 is the mass of a sheet in its 'a& 'efore sterili$ation# in &ramsJ
mA is the mass of the same sheet in its 'a& after sterili$ation# in &rams;
22.1.2.12 2eport the mean of the three results and chec7 that it complies with 8;9;1;
22.2 oa' 'r/ness5 %.ll loa'5 te7tiles
NBTE; The load dr/ness test# full load te0tiles# is used to demonstrate that the sterili$ation c/cle will not cause an unaccepta'le le%el of
moisture to 'e a'sor'ed '/ a standard test pac7 located in a full load of te0tiles#
22.2.1 pparatus
22;2;1;1!ull load# te0tiles as descri'ed in 26;6;
22;2;1;2 .ol/eth/lene 'a&s# three# "5< mm I 25< mm or lar&er# manufactured from pol/eth/lene sheet with a
thic7ness not less than 25< pm
22;2;1;"Balance# capa'le of wei&hin& a load of at least 1 7& and with an accurac/ of at least
B
<#1 &;
22;2;1;9 *ndeli'le mar7er;
22;2;1;5 Stopwatch;
22;2;1;6 Connected ser%ices compl/in& with clause 1";
22.2.2 Procedure
22;2;2;1 (llow the sheets of the standard test pac7 to e>uili'rate as descri'ed in 26;1;
22;2;2;2 1ar7 three of the sheets from the standard test pac7 and similarl/ mar7 each of the pol/eth/lene 'a&s so
that all are indi%iduall/ identified
22;2;2;" Gei&h each of the pol/eth/lene 'a&s (mi)
22;2;2;9 .lace one of the mar7ed sheets in each of the 'a&s# wei&h each 'a& and record its mass (m>)
22;2;2;5 2emo%e the sheets from the 'a&s and replace them in the standard test pac7J place one in the centre and
one in the second sheet from either end of the standard test pac7; Secure the standard test pac7 as descri'ed in
26;1;
22;2;2;8 .lace the test load in the sterili$er cham'er as descri'ed in 26;6 and carr/ out a sterili$ation c/cle;Start the
sterili$ation c/cle within 6< s of placin& the test load in the sterili$er cham'er;
22;2;2;9 (t the completion of the sterili$ation c/cle# and after not more than 6< s# remo%e the standard test pac7
from the sterili$er cham'er; 2emo%e the three mar7ed sheets from the standard test pac7 and immediatel/ transfer
them to their appropriate 'a&s; eal each 'a& '/ turnin& its open end o%er se%eral times; Ensure that the total time
ta7en from the end of the sterili$ation c/cle to the enclosure of the sheets does not e0ceed 18< s;
NBTE; The transfer of the sheets to the pol/eth/lene 'a&s should 'e accomplished with the &reatest possi'le econom/ of mo%ement in order
to minimi$e loss of retained moisture;
22.2.2.11 Calculate the chan&e in moisture content +in per cent- of each sheet usin& the formula:
where
m1 is the mass of the pol/eth/lene 'a&# in &ramsJ
m2 is the mass of a sheet in its 'a& 'efore sterili$ation# in &ramsJ
m3 is the mass of the same sheet in its 'a& after sterili$ation# in &rams;
22.2.2.12 2eport the mean of the three results and chec7 that it complies with 8;9;2;
22.* oa' 'r/ness5 metal loa'
NBTE 1; The load dr/ness test# metal# is performed with a reference sterili$er load and is used to demonstrate that the sterili$ation
c/cle is unli7el/ to cause moisture pro'lems in routine production loads;
NBTE 2; *f moisture pro'lems are identified after the test has 'een successfull/ completed the cause can 'e the t/pe of load and its location
in the sterili$er cham'er;
22.*.1 pparatus
22;";1;1 Test pac7# metal as descri'ed in 26;8;
22;";1;2 Balance# capa'le of wei&hin& a load of at least 15 7& and with an accurac/ of at least L 1 &;
22;";1;"Stopwatch;
22;";1;9 Connected ser%ices compl/in& with clause 1";
22.*.2 Procedure
22;";2;1 Ensure that all items used to form the test pac7 shall 'e e>uili'rated to am'ient conditions;
22;";2;2 Gei&h the test pac7# metal# and record its mass (mi)
22;";2;" Select the sterili$ation c/cle to 'e tested;
22;";2;5 .lace the test pac7# metal# in the usa'le space# on the lower shelf;
22;";2;6 !ill the remainin& usa'le space with steel o'=ects to &i%e an appro0imate mass of 29 7& in each sterili$ation
module;
(ll items shall 'e e>uili'rated to am'ient conditions;
22;";2;5 Carr/ out a sterili$ation c/cle;
22;";2;8 (t the completion of the sterili$ation c/cle remo%e the test pac7# metal# from the sterili$er cham'er and
wei&h# within a total period of 5 min;
2ecord its mass (wiCD)
22.*.2.9 Calculate the chan&e in moisture content +in per cent- usin& the formula:
where
m1 is the mass of the pol/eth/lene 'a&# in &ramsJ
m2 is the mass of a sheet in its 'a& 'efore sterili$ation# in &ramsJ
m> is the mass of the same sheet in its 'a& after sterili$ation# in &rams;
22.*.2.1( Chec7 that the result complies with 8;9;";
2* So.n' #o,er test
NBTE; National le&islation controls the percei%ed noise +sound pressure- in the wor7in& en%ironment; Sound pressure le%els sensed in a room
are a function of the sound power &enerated '/ the source# e;&; the sterili$er# and the acoustic desi&n of the room in which the source is
installed; The purpose of this test is to ensure compliance with the re>uirement for pea7 sound power &enerated '/ a sterili$er and to
ensure that the le%el of the wei&hted sound power is 7nown and a%aila'le for the desi&n of the installation;
2*.1 A##arat.s
2";1;1 ( sound le%el meter# compl/in& with T/pe 1 of EN 6<651: 1999 or an inte&ratin& a%era&in& sound le%el meter#
compl/in& with T/pe 1 of EN 6<8<9 :1999;
2";1;2 Test room# with a sound reflectin& floor +e;&; tiles# concrete-;
2";1;" !ull load# te0tiles# as descri'ed in 26;6;
2*.2 1ro-e'.re
2*.2.1 ocate the microphones in the position descri'ed in 7.*.1 of EN *SB "596:1995;
NBTE 1; The reference surface is the smallest rectan&ular parallelepiped +'o0- that =ust encloses the sterili$er; *t is a 'o0 formed '/ the
structure and co%erin&s or# where these are not fitted# it is a 'o0 ha%in& a width and depth measured from the outside of the %essel la&&in&
and a hei&ht measured from the floor to the top of the %essel la&&in&;
NBTE 2; The reference surface does not include pipes and %al%es used to connect the sterili$er to its ser%ices;
2*.2.2 ,etermine the en%ironment correction factor E
as descri'ed in (;" of EN *SB "596: 1995; This %alue
shall not e0ceed the %alue &i%en in 8;2 of
EN *SB "596:1995;
2*.2.* Gith the sterili$er containin& the test load carr/
out the test# ensurin& that the pressure and flow from
the steam and water ser%ices are set to le%els which
cause the ma0imum noise and are within the ran&es
specified for the sterili$er;
NBTE; Ghen the sterili$er is desi&ned for a num'er of sterili$ation c/cles# the te0tile c/cle emplo/in& the hi&hest temperature should 'e
selected;

2*52.9 @sin& the procedure for measurements on a rectan&ular measurement surface descri'ed in 7.* of EN *SB
"596:1995# determine the (Cwei&hted sound power le%el +WG(-
anO
i Qh
e
ma0imum sound power le%el +G( ma0-X of
the sterili$er for one complete sterili$ation c/cle;
NBTE; The sound power le%el is determined from a num'er of sensor positions; *f the sound meter has insufficient input channels# additional
instruments and8or repeated sterili$ation c/cles are performed;
2*.* Test res.lt
2ecord the calculated mean and ma0imum (Cwei&hted sound power le%els in deci'els to the nearest inte&er and
chec7 that the ma0imum (Cwei&hted sound power complies with clause 9;
NBTE; Bther information should 'e recorded as re>uired '/ EN *SB "596:1995;
29 Steam :.alit/ tests
29.1 Non0-on'ensa$le !ases
NBTE 1; The steam >ualit/ test# nonCcondensa'le &ases# is used to demonstrate that the le%el of nonCcondensa'le &ases contained in the steam
will not pre%ent the attainment of sterili$ation conditions in an/ part of the sterili$er load; The test method descri'ed should 'e re&arded
not as measurin& the e0act le%el of nonCcondensa'le &ases 'ut as a method '/ which the pro%ision of accepta'le steam >ualit/ can 'e
demonstrated;
NBTE 2; (n alternati%e procedure to the one descri'ed in 29;1 can 'e used pro%idin& it has 'een cali'rated a&ainst this standard;
29.1.1 pparatus
29;1;1;1 Burette# of 5< ml +nominal- capacit/# ha%in& a
minimum scale mar7 of 1 ml;
29;1;1;2 !unnel# with parallel sides and a ma=or
diameter of appro0imatel/ 5< mm;
29;1;1;" Container of 2<<< ml +nominal- capacit/ and
with an o%erflow pipe to limit the contained capacit/
to appro0imatel/ 15<< ml;
29;1;1;9 Samplin& pipe# T! shaped# made from 6 mm
+nominal- outside diameter &lass tu'in& and with
a 55 mm +nominal- deli%er/ lim';
29;1;1;5 Small needle %al%e# ha%in& a 1 mm +nominal- orifice and with suita'le fittin&s for connection to the steam
pipe and ru''er samplin& tu'e;
29;1;1;6 3raduated c/linder of 25< ml +nominal- capacit/ and ha%in& minimum scale mar7 of 1< ml;
29;1;1;5 Burette stand
29;1;1;8 2u''er tu'in& +95< L 5<- mm lon&# selfCdrainin& and ha%in& a 'ore suita'le for connection to the samplin&
pipe and needle %al%e;
29;1;1;9 Temperature measurement s/stem with an accurac/ of at least 1 A at 8< KC;
29;1;1;1< Bne temperature sensor as descri'ed
in 2).*.
29.1.2 Procedure
29;1;2;1 Connect the needle %al%e to the steam pipe
as shown in fi&ure 5;
29;1;2;2 (ssem'le the apparatus as shown in fi&ure 5 and then locate it in a position which will allow the free
draina&e of condensate throu&h the ru''er tu'in&;
29;1;2;" !ill the container with cold deCaerated water +water which has 'een 'oiled for 5 min and then cooled-# until
it flows throu&h the o%erflow pipe;
29;1;2;9 !ill the 'urette with cold deCaerated water# in%ert it and place it in the container ensurin& that no air is
introduced into the 'urette;
29;1;2;5 Gith the steam samplin& pipe out of the container# open the needle %al%e and pur&e all air from the pipe;
.lace the samplin& pipe in the container and add more cold deCaerated water until it flows throu&h
the o%erflow pipe;
29;1;2;6 .osition the &raduated c/linder under the container o%erflow and locate the steam samplin& pipe within the
funnel; (d=ust the needle %al%e to allow a
continuous sample of steam into the funnel sufficient to cause a small amount of Dsteam hammerD to 'e heard;
Ensure that the steam enterin& the funnel is dischar&ed so that the nonCcondensa'le &ases are
collected in the 'urette;
29;1;2;5 Close the needle %al%e# after first notin& the DopenD position;
29;1;2;8 .lace the standard test pac7 a'o%e the nominal &eometric centre of the hori$ontal plane of the usa'le space
29.1.2.9 Start a sterili$ation c/cle and ensure that the &raduated c/linder is empt/ and the container is filled with
water; Ghen the steam suppl/ to the sterili$er cham'er commences# reCopen the needle %al%e to
allow a continuous sample of steam into the funnel sufficient to cause a small amount of Dsteam hammer to 'e
heard;
29.1.2.1( (llow the steam sample to condense in the funnel and the nonCcondensa'le &ases to rise to the top of
the 'urette; Collect the o%erspill formed '/ the condensate and the water displaced '/ the &ases in the &raduated
c/linder; Close the needle %al%e when the temperature of the water in the container is 'etween 5< KC and 55 KC;
2ecord the %olume +5
'
- of water displaced from the 'urette and the %olume +!
c
- of water collected in the &raduated
c/linder;
NBTE; ( se>uence of tests should 'e underta7en to determine whether the le%el of nonCcondensa'le &ases in the steam is %aria'le;
NBTE; *f the connection to the steam pipe is less than "<< mm from the pitot connection# +see fi&ure 9- reproduci'ilit/ of the test can 'e
affected;
6i!.re 7. Dia!rammati- re#resentation o% t&e a##arat.s %or t&e meas.rement o% non0-on'ensa$le
!ases
where
0F) is the %olume of water displaced from the 'urette# in millilitresJ
0
c
is the %olume of water collected in the &raduated c/linder# in millilitres;
29.1.2.12 Chec7 that the result complies with the re>uirements specified in 1*.*.2.
29.2 Dr/ness
NBTE 1; ( continuous suppl/ of dr/ saturated steam is re>uired for steam sterili$ation; E0cess moisture carried in suspension can cause
damp loads# while too little cannot pre%ent the steam from 'ecomin& superheated durin& e0pansion into the sterili$er cham'er; The
accurate measurement of the percenta&e of moisture content in the steam is difficult and the traditional methods where constant steam flow
is re>uired are not suita'le for sterili$ers; The test method descri'ed should 'e re&arded not as measurin& the true content of moisture in
the steam# 'ut as a method '/ which the pro%ision of accepta'le steam >ualit/ can 'e demonstrated;
NBTE 2; (n alternati%e procedure to the one descri'ed in 29;2 can 'e used pro%idin& it has 'een cali'rated a&ainst this standard;
29.2.1 pparatus
29.2.1.1 .itot tu'e constructed as shown in fi&ure 8 and fitted with a sensin& tu'e ha%in& a nominal 'ore to suit the
pressure in the steam pipe from which the sample is to 'e ta7en;
29.1.2.11 Calculate the concentration of nonC
condensa'le &ases as a percenta&e as follows:
29;2;1;2 ,ewar flas7 of 11 nominal capacit/;
29;2;1;" 3land for insertin& a temperature sensor into the steam pipe;
29;2;1;9 Thermometric recordin& instrument as descri'ed in 26;9 'ut ha%in& a scale ran&e which includes < KC
to 2<< KC;
29;2;1;5 Two temperature sensors as descri'ed in 26;";
29;2;1;6 2u''er stopper# fitted with two 6 mm +nominal- outside diameter pipes for insertion into the ,ewar flas7;
Nominal len&ths of insertion of the pipes 25 mm and 15< mm respecti%el/; 2u''er tu'in&# selfCdrainin&# ha%in& a
len&th of +95< L 5<- mm and a 'ore suita'le for connection to the pitot tu'e and the lon&er of the tu'es in the ru''er
stopper;
29;2;1;5 Balance# capa'le of wei&hin& a load of at least 2 7& and with an accurac/ of at least L <#1 &;
29.2.2 Procedure
29;2;2;1 Carr/ out a steam >ualit/ test for nonCcondensa'le &ases in accordance with 29;1; *f the %alues are not
within the limits specified in 1*.*.2 the
fault shall 'e corrected 'efore carr/in& out this test;
29;2;2;2 @it the pitot tu'e concentricall/ within the steam ser%ice pipe as shown in fi&ure 9;
29;2;2;" !it the temperature sensor entr/ &land to the steam ser%ice pipe and locate one of the temperature sensors
at the nominal a0ial centre of the pipe;
29;2;2;9 Connect the ru''er tu'e to the lon&er of the pipes in the stopper and then place the stopper in the nec7 of
the ,ewar flas7# wei&h the whole assem'l/ and record the mass +ra
e
-;
29;2;2;5 Ghere the sterili$er has a num'er of sterili$ation c/cles# select the te0tile c/cle with a sterili$ation
temperature of 1"9 KC;
29;2;2;6 Can/ out a sterili$ation c/cle with the sterili$er cham'er empt/;

29;2;2;5 2emo%e the stopper and tu'e assem'l/ and place +65<
B
5<- ml of water at a temperature not e0ceedin& 25
KC into the ,ewar flas7; 2eplace the stopper and tu'e assem'l/# wei&h the whole assem'l/
and record the mass +m
s
-;
29;2;2;8 Support the ,ewar flas7 close to the pitot tu'e connection point and in a position which is protected from
e0cess heat and drau&hts;
29.2.2.9 .lace the standard test pac7 as descri'ed in 2).1 in the sterili$er cham'er;
29;2;2;1< *ntroduce the second temperature sensor throu&h the shorter of the pipes in the stopper and into the
,ewar flas7;
29;2;2;11 Note the temperature of the fluid in the ,ewar flas7 +Ti-;
29;2;2;12 Carr/ out a sterili$ation c/cle; Ghen the steam %al%e connected to the sterili$er cham'er first opens#
attach the ru''er tu'e to the pitot tu'e connection point# ensurin& free draina&e of condensate
into the ,ewar flas7;
29;2;2;1" Note the temperature of the steam YT
"
-;
29;2;2;19 Ghen the temperature of the water in the ,ewar flas7 is appro0imatel/ 8<
C
C# disconnect the ru''er tu'e
from the pitot tu'e connectionJ a&itate the flas7 so that the contents are thorou&hl/ mi0ed and
then note )ie temperature of the fluid +TR-;
29;2;2;15 Gei&h the ,ewar flas7 complete with water# condensate# stopper and tu'e +mS-;
29;2;2;16 Calculate the dr/ness %alue of the steam from the e>uation:
where
L is the latent heat of dr/ saturated steam at
temperature (/ in 7ilo=oules per 7ilo&ramJ m
e
is the mass of the ,ewar flas7 and stopper#
pipes and tu'e# in 7ilo&ramsJ m
s
is the mass of the ,ewar flas7# water char&e#
stopper# pipes and tu'e# in 7ilo&ramsJ mf is the mass of the flas7# water char&e#
condensate# stopper# pipes and tu'e in
7ilo&ramsJ
,imensions in millimetres
1 pitot tu'e
2 temperature sensor fittin&
" e0pansion tu'e
6i!.re 11. Dia!rammati- re#resentation o% t&e a##arat.s %or t&e meas.rement
o% s.#er&eat
1 Suita'le fittin& for locatin& a temperature sensor into the tu'e
2 N/lon soc7et# fit into the tu'e
6i!.re 1(. E7#ansion t.$e
9 to temperature measurin& instrument
5 to sterili$er
6 from steam ser%ice
(- is the initial temperature of the water in the
,ewar flas7# in de&rees CelsiusJ (C8 is the final temperature of the water and
condensate in the ,ewar flas7# in de&rees
CelsiusJ 5Q" is the temperature of dr/ saturated steam
deli%ered to the sterili$er# in de&rees CelsiusJ Cp
G
is the specific heat capacit/ of water
+9#187Z87&QA-J
! is the dr/ness %alue of the steamJ A is the effecti%e heat capacit/ of the apparatus
+<#29 7Z8A-;
29.2.2.17 Chec7 that the result complies with 1*.*.*.
29.* S.#er&eat
NBTE 1# The steam >ualit/ test# superheat is used to demonstratO that the amount of moisture in suspension with steam supplied from the
ser%ice suppl/ is sufficient to pre%ent the steam from 'ecomin& superheated durin& e0pansion into the sterili$er cham'er;
NBTE 2; The test method descri'ed in 29;" uses a low %olume sample# continuousl/ ta7en from the centre of the steam ser%ice pipe; The
le%el of superheat determined '/ this method cannot ' re&arded as the true dr/ness of the steam in the pipe since condensate flowin&
alon& the inside surface is not collected; )owe%er# de%ices desi&ned to separate free condensate are incorporated into the steam deli%er/
s/stem to the sterili$er cham'er and therefore the le%el determined '/ this method is representati%e of steam conditions li7el/ to pre%ail
within the sterili$er cham'er durin& the plateau period;
NBTE "; (n alternati%e procedure to the one descri'ed in 29;" can 'e used# pro%idin& it has 'een correlated to this method;
29.*.1 pparatus
29;";1;1 .itot constructed as shown in fi&ure 8 and
ha%in& a nominal 'ore of 1 mm;
29;";1;2 E0pansion tu'e as shown in fi&ure 1<;
1 pitot tu'e
2 temperature sensor fittin&
" e0pansion tu'e
9 to temperature measurin& instrument
5 to sterili$er
6i!.re 11. Dia!rammati- re#resentation o% t&e a##arat.s %or t&e meas.rement o% s.#er&eat
29;";1;" 15< mm +nominal- len&th of 15 mm pipe la&&in&;
29;";1;9 Thermometric recordin& instrument as descri'ed in 26;9;
29;";1;5 Two temperature sensors as descri'ed in 26;";
29;";1;6 3land for insertin& a temperature sensor into the steam pipe;
NBTE; To minimi$e heat transfer 'etween the fittin& and temperature sensor# insulation can 'e re>uired;
29.*.1.7 !ull load# te0tiles as descri'ed in 2).).
29.*.2 Procedure
29;";2;1 !it the pitot tu'e concentricall/ within the steam ser%ice pipe as shown in fi&ure 11;
29;";2;2 !it the temperature sensor entr/ &land to the steam pipe and locate one of the temperature sensors
at the nominal a0ial centre# as shown in fi&ure 9;
29;";2;" Throu&h the &land pro%ided# locate the second temperature sensor at the appro0imate hori$ontal a0is of
the e0pansion tu'e;
29;";2;9 (ttach the pipe la&&in& around the e0pansion tu'e and push the e0pansion tu'e on to the pitot;
29;";2;5 Connect the temperature sensors to the thermometric recordin& instrument;
29;";2;5 .lace the full load# te0tiles in the usa'le space as descri'ed in 26;6 and within 5 min carr/ out a further
29;";2;8 (t the end of the sterili$ation c/cle# chec7
the temperature recordin&s:
C for compliance with the re>uirement specified
in 1*.*.9B
C to confirm that the temperature measured in the
steam pipe did not differ '/ more than " A from that
measured in the steam pipe durin& the steam >ualit/#
dr/ness test
NBTE; This temperature is a parameter from which the %aria'ilit/ of the steam pressure 'etween se>uential c/cles can 'e assessed; ( hi&her
temperature difference can cause operational pro'lems resultin& from the moisture content in the steam;
29.9 1ro-e'.re %or sam#lin! steam -on'ensate 29.9.1 pparatus
29;9;1;1 .itot tu'e constructed as shown in fi&ure 8 and fitted with an orifice ha%in& a nominal 'ore to suit the
pressure in the steam ser%ice pipe from which the sample is to 'e ta7en;
29;9;1;2 .ol/prop/lene tu'e +5<<< L 5<- mm lon& and ha%in& a 'ore +6 - 1- mm;
1 pitot tu'e
2 pol/prop/lene tu'e# coiled as shown
" to sterili$er
9 8<<< ml container
5 'urette stand
6 25< ml pol/prop/lene 'ottle
5 to trap set
6i!.re 12. A##arat.s %or sam#lin! steam -on'ensate
29;9;1;" Two &raduated pol/prop/lene 'ottles# each ha%in& a nominal capacit/ of 25< ml;
29;9;1;9 Container with a minimum capacit/ of 81;
29;9;1;5 (ppro0imatel/ 1 7& of ice;
29;9;1;6 ( clip or connector which can 'e used to secure the pol/prop/lene tu'e to the pitot;
29;9;1;5 ( piece of metal of a mass and si$e suita'le for retainin& a num'er of coils of the pol/prop/lene
tu'e in the container;
29;9;1;8 Small %olume of concentrated h/drochloric acid;
29.9.2 Procedure
29;9;2;1 !it the pitot tu'e into the steam ser%ice pipe as shown in fi&ures 9 and 12;
29;9;2;2 @sin& the clip# secure the pol/prop/lene tu'e to the pitot connection;
29;9;2;" Bpen the %al%e on the steam ser%ice pipe and dischar&e steam condensate throu&h the pol/prop/lene tu'e
for a minimum period of 5 rain;
Ensure the condensate drains freel/;
29;9;2;9 Clean and rinse 'oth the inside of the pol/prop/lene tu'e and the two 'ottles with distilled water and then
dr/ them; Close the steam %al%e;
29;9;2;5 (rran&e the 'urette and one of the 'ottles as shown in fi&ure 12;
29;9;2;6 Coil part of the pol/prop/lene tu'in& into a sufficient num'er of coils to ensure condensation of steam#
place in the container and retain '/ the metal wei&ht;
29;9;2;5 !ill the container with the ice and a sufficient >uantit/ of cold water to immerse the tu'in&;
29;9;2;8 Bpen the steam ser%ice %al%e;
29.9.2.9 (llow at least 5< ml of steam condensate to
dischar&e to waste and then collect 25< ml +nominal- in
the first &raduated 'ottle;
29;9;2;1< Seal this pol/prop/lene 'ottle;
29;9;2;11 (dd sufficient concentrated h/drochloric
acid to the second pol/prop/lene 'ottle to &i%e a final
concentration of C+)C*- T<#1 mol81 and then
collect 25< ml of condensate and seal the 'ottle; 1ar7 the 'ottle Tor trace metal anal/sisD;
29.9.2.12 (nal/se the samples and compare the
results with the su&&ested ma0imum le%els &i%en in
ta'le B;*;
25 D/nami- sterilizer -&am$er #ress.re test
NBTE; The d/namic sterili$er cham'er pressure test is used to demonstrate that the rate of pressure chan&e occurrin& in the sterili$er
cham'er durin& a sterili$ation c/cle does not e0ceed a le%el which can cause dama&e to the pac7a&e; This le%el is used as a performance
re>uirement for pac7a&in& materials compl/in& with prEN 868 and has 'een chosen on the 'asis of a compromise 'etween the need to pro%ide
cost effecti%e pac7a&in& and short# efficacious sterili$ation c/cles;
25.1 A##arat.s
25.1.1 .ressure recordin& instrument as descri'ed in 2).5.
25.2 1ro-e'.re
25;2;1 (ttach the pressure recordin& instrument to the
test connection +see 9.*.*.1< usin& the prescri'ed
connectin& tu'e;
25;2;2 Carr/ out an air lea7a&e test as descri'ed in
clause 2<; ,o not proceed if the air lea7a&e flow rate
e0ceeds that specified in 8.*.2.2.
25;2;" Select the sterili$ation c/cle to 'e tested;
25;2;9 Carr/ out a sterili$ation c/cle with the sterili$er
cham'er empt/ and o'ser%e and record the times#
temperatures and pressures at all si&nificant parts of
the sterili$ation c/cle;
25;2;5 (t the completion of the test# proceed as
follows:
C e0amine the records specified a'o%e for
compliance with the c/cle specificationJ
C chec7 that the pressure difference 'etween
consecuti%e measurements complies with clause 1<;
2) Test a##arat.s5 e:.i#ment an' material
2).1 Stan'ar' test #a-;
NBTE 1; This test# pac7 is used to chec7 that# at the le%els at which the process %aria'les are set# rapid and e%en penetration of steam into the
pac7 is attained;
NBTE 2; *t is used for the Bowie and ,ic7 test# the small load test# air detector tests# load dr/ness test# te0tiles and can 'e used with other
materials to form a full load;
26;1;1 The test pac7 shall 'e composed of plain cotton sheets# each 'leached to a &ood white and ha%in& an
appro0imate si$e of 9<< mm I 12<< mm; The num'er of threads per centimetre in the warp shall 'e +"< L 6- and the
num'er of threads per centimetre in the weft shall 'e +25 L 5-;
26;1;2 The sheets shall 'e washed when new and when soiled and shall not 'e su'=ected to an/ fa'ric conditionin&
a&ent;
NBTE; !a'ric conditionin& a&ents can affect the characteristics of the fa'ric and can contain %olatiles which will contri'ute to the nonC
condensa'le &ases in the sterili$er cham'er;
26;1;" The sheets shall 'e dried and then aired for at least 1 h at a temperature of 'etween 15 KC and 25 KC# with a
relati%e humidit/ of "< M to 5< M;
26;1;9 (fter airin&# the sheets shall 'e folded to appro0imatel/ 22< mm I "<< mm and stac7ed to a hei&ht of
appro0imatel/ 25< mm; (fter compressin& '/ hand# the pac7 shall 'e wrapped in similar fa'ric and then secured with
tape not e0ceedin& 25 mm in width; The total wei&ht of the pac7 shall 'e 5 7& L 1< M;
NBTE 1; .ac7s which are not used within 1 h of preparation can 'e stored in the wor7Croom# pro%ided the en%ironmental conditions are
maintained within the limits specified a'o%e; NBTE 2; (fter use# the sheets will 'ecome compressed; Ghen the wei&ht of sheets used to form a
stac7 25< mm hi&h e0ceeds 5#5 7&# the sheets should 'e discarded;
2).1.5 Test pac7s comprisin& different materials and of different si$es and wei&hts can 'e used# pro%ided
e>ui%alence with the re>uirements for the test in which the standard test pac7 is used is demonstrated
+see 17.15 18.15 -la.se 195 21.15 21.* and 22;1-;
2).2 1ress.re !a.!es
2).2.1 Test pressure &au&es shall 'e used to chec7 pressure indicatin& and recordin& instruments;
NBTE; Bther test instruments# e;&; instruments incorporatin& transducers# can 'e used pro%ided the/ are suita'le for the purpose and
pro%ided the/ are certified and are no less accurate than the test &au&es specified;
26;2;2 The minimum scale len&th shall 'e 29< mm;
26;2;" Two test &au&es shall 'e used# one with a scale ran&e < m'ar to 16< m'ar a'solute +< 7.a to 16 7.a- and the
other < 'ar to 9 'ar a'solute +< 7.a to 9<< 7.a-; Both test &au&es shall compl/ with an accurac/ class of at least <#25;
26;2;9 Each test &au&e shall ha%e a %alid test certificate;
26;2;5 Cali'ration of each &au&e shall 'e carried out usin& a wor7in& or reference standard which is tracea'le to the
national standard or a primar/ standard;
26;2;6 Each test &au&e shall 'e cali'rated in accordance with the manufacturerDs instructions;
2).* Tem#erat.re sensors
26;";1 Temperature sensors shall 'e used to sense the temperature in locations specified in the tests descri'ed in
this standard;
26;";2 Temperature sensors shall 'e either platinum resistance and compl/ with Class ( of EN 6<551 or
thermocouple and compl/ with one of the ta'les of tolerance class 1 of EN 6<589C2;
26;";" The ma=or diameter of the temperature sensors used within the sterili$er cham'er shall not
e0ceed 2 mm when measured o%er the secondar/ insulation of the connectin& wires;
26;";9 The performance characteristic for the temperature sensor shall not 'e affected '/ the en%ironment in
which it is placed# e;&; pressure# steam or %acuum;
26;";5 The temperature measured '/ all temperature sensors when immersed in a temperature source at a
temperature 7nown to within - <#1 A# and within the sterili$ation temperature 'and# shall not differ '/ more than <#5
A after cali'ration;
2).9 T&ermometrie re-or'in! instr.ment
26;9;1 ( thermometric recordin& instrument+s- shall 'e used in con=unction with temperature sensors to record the
temperatures measured in the locations specified in the tests descri'ed in this standard; *t can also 'e used to chec7
thermometric instruments fitted to the sterili$er;
26;9;2 The recordin& instrument shall record the temperature from a minimum of three temperature sensors; The
channels can 'e multiple0ed or independent of each other; The samplin& rate for each channel shall 'e 2#5 s or less;
(ll data sampled shall 'e used for the interpretation of the results;
26;9;" The scale ran&e for analo&ue instruments shall include < KC to 15< KC; The minor mar7 inter%al shall not
e0ceed 1 A and the chart speed shall 'e not less than 15 mm8min; The resolution shall not 'e less than <#5 A;
26;9;9 ,i&ital instruments shall re&ister and record in increments of not more than <#1 A and the scale ran&e shall
include < KC to 15< KC;
26;9;5 (he limit of error 'etween < KC and 15< KC +e0cludin& temperature sensors- shall not e0ceed L <#25 M when
tested in an am'ient temperature of +2<L"-KC;
26;9;6 The additional error due to the chan&e in the en%ironmental temperature shall not e0ceed <#<9 A8A;
26;9;5 Cali'ration shall 'e carried out usin& a wor7in& or reference standard which is tracea'le to the national
standard or a primar/ standard;
26;9;8 The instrument shall ha%e a %alid test certificate;
2).9.9 The instrument shall 'e cali'rated in accordance with the manufacturerDs instructions and cali'ration shall
include a temperature within the sterili$ation temperature 'and; Ghen installed in the place of use# the temperature
s/stem shall 'e %erified with an independent temperature reference source at a temperature within the sterili$ation
temperature 'and;
26;9;1< The temperature reference source shall ha%e the followin& features;
C *t shall incorporate a reference standard thermometer which is tracea'le to the national standard or a primar/
standard and shall include the ran&e 11< KC to 19< KC; The minor mar7 inter%al shall not e0ceed <#2 A
C *t shall incorporate a poc7et# si$ed to accommodate a minimum of three temperature sensors as descri'ed in
2).*. The temperature &radient within the poc7et shall not e0ceed <#2 A and the control accurac/ shall 'e within L
<#1 A o%er the ran&e of 1<< KC to 19< KC;
2).5 1ress.re re-or'in! instr.ment
26;5;1 ( pressure recordin& instrument shall 'e used in con=unction with a pressure sensiti%e measurin& element to
record the pressure within the sterili$er cham'er durin& a test sterili$ation c/cle; *t can also 'e used to chec7 the
pressure instruments- fitted to the sterili$er;
26;5;2 The instrument ma/ 'e inte&rated into the temperature recordin& instrument as an additional channel
cali'rated for pressure; The samplin& rate for each channel shall 'e 1 s or less; (ll data sampled shall 'e used for the
interpretation of the results;
26;5;" The scale ran&e for analo&ue instruments shall include < 'ar to 9 'ar a'solute +< 7.a to 9<< 7.a-; The minor
mar7 inter%al shall not e0ceed <#<9 'ar +9 7.a- and the chart speed shall 'e not less than 15 mm8min; The resolution
shall 'e not less than <#<2 'ar +2 7.a-;
26;5;9 ,i&ital instruments shall re&ister and record in increments of not more than <#<1 'ar +1 7.a- and the scale
ran&e shall include < 'ar to 9 'ar a'solute +< 7.a to 9<< 7.a-;
26;5;5 The limit of error 'etween < 'ar and 9 'ar a'solute +< 7.a to 9<< 7.a-# the indicator and measurin& s/stem
shall not e0ceed - <#5 M when measured in an am'ient temperature of +2< L "- KC;
26;5;6 The temperature coefficient of the measurin& s/stem shall not e0ceed <#<1 GE at the temperature at which
the pressure sensor is to 'e used;
26;5;5 The error due to the chan&e in the en%ironmental temperature shall not e0ceed <#<2 M8A
26;5;8 The natural fre>uenc/ of the sensor and connected tu'in& shall 'e not less than 1< )$ and the time constant
+< M to 6" M- for risin& pressure not &reater than <#<9 s;
2).5.9 The instrument shall ha%e a %alid test certificate;
26;5;1< Cali'ration shall 'e carried out usin& a wor7in& or reference standard which is tracea'le to the national
standard or a primar/ standard;
26;5;11 The instrument# when connected to a pressure sensiti%e element# shall 'e cali'rated in accordance with the
manufacturerDs instructions and cali'ration shall include a pressure within the sterili$ation pressure 'and;
2).) 6.ll loa'5 te7tiles
NBTE; This test load is desi&ned to represent the ma0imum mass of te0tiles which can 'e processed in the sterili$er and is used to
demonstrate that# at the le%els at which c/cle %aria'les are set# rapid and e%en penetration of steam into the centre of a load occurs and the
sterili$in& condition is achie%ed;
26;6;1 The full load shall comprise folded sheets and a standard test pac7 as descri'ed in 26;1;
26;6;2 Each sheet shall contain at least 5< M m)m of cotton fi're and ha%e a mass per unit area of appro0imatel/
2<< &8m
2
; The sheets shall 'e laundered when new or soiled and not su'=ected to an/ fi're conditionin& a&ent +see
2).1<.
26;6;" The sheets shall 'e dried and then aired for at least 1 h at a temperature of 'etween 15 KC and 25 KC and at a
relati%e humidit/ "< M to 5< M;
26;6;9 (fter airin&# the sheets shall 'e folded and laid one on top of the other to form a stac7 with a 'ase area of
appro0imatel/ 25< mm I 5<< mm and a mass of +5#5 L<#5- 7&;
NBTE; Stac7s which are not used within 1 h of preparation can 'e stored in the wor7 room pro%ided the en%ironmental conditions are
maintained within the limits specified a'o%e;
26;6;5 The standard test pac7 shall 'e located within the sterili$er cham'er# and in a position identified '/ the
manufacturer as the most difficult to sterili$e; The remainder of the usa'le space shall 'e loaded with stac7s of
sheets each with the la/ers of fa'ric in the 'as7ets dimensiona@/ similar to one sterili$ation module# or the/ can 'e
loose within the sterili$er cham'er;
26;6;6 The mass of fa'ric in the test load shall 'e e>ui%alent to +5#5 L <#5- 7& per load module;
2).7 Test #a-;5 r.$$er
NBTE; This test pac7 is used to represent a unit of ru''er o'=ects# e;&; tu'in&# in which specified sterili$in& conditions are difficult to achie%e;
2).7.1 The test pac7# ru''er shall comprise a stac7 of pac7a&es 1<< mm hi&h and occup/in& a %olume e>ui%alent to
half of a sterili$ation module; Githin this stac7 of pac7a&es three pac7a&es shall contain test pieces as descri'ed
'elow and the remainin& pac7a&es shall contain a piece of natural ru''er tu'in& ha%in& a nominal si$e of 15<< mm
len&th# 5 mm outside diameter and " mm inside diameter; The ru''er tu'in& shall 'e coiled in the same plane into a
spiral; (ll pac7a&es shall 'e dou'leCwrapped in si$e 9< plastic paper 'a&s compl/in& with prEN 868C5# with the paper
of each 'a& on the same side;
26;5;2 Each test piece shall comprise three inoculated carriers compl/in& with prEN 866C"# +consistin& of a carrier of
&lass tu'in& of nominal dimensions# e0ternal diameter 9#< mm# internal diameter 2#5 mm and len&th 95 mm- inserted
as spi&ots to re=oin a piece of natural ru''er tu'in& of nominal si$e 15<< mm len&th# 5 mm outside diameter# " mm
inside diameter; Bne inoculated carrier shall 'e located in the middle of the tu'in& and one appro0imatel/ 2<< mm
from each end of the tu'in&;
26;5;" The stac7 of pac7a&es shall 'e assem'led with the paper side of each pac7a&e facin& downwards and the
three pac7a&es containin& the test pieces shall 'e located within the stac7 at nominal hei&hts of 25 mm# 5< mm and
55 mm;
NBTE; The stac7 should 'e supported# for e0ample# '/ a wire mesh 'as7et;
26;5;9 (llow the stac7 to e>uili'rate for at least 1 h at a temperature of 'etween 15 KC and 25 KC at a relati%e
humidit/ "< M to 5< M;
26;5;5 Store the test pac7 until re>uired in an en%ironment maintained within the limits specified a'o%e;
2).8 Test #a-;5 metal
NBTE; This test pac7 is used to represent a unit of metal o'=ects# e;&; instruments# which is difficult to dr/;
26;8;1 Sterili$er load shall comprise a test 'o0 containin& a wire mesh 'as7et and a >uantit/ of metal screws
wrapped in te0tile material
26;8;2 The test 'o0 shall:
C ha%e a sealed lid and compl/ with the detail &i%en in fi&ure 1"J
C not ha%e additional holes to those shown in fi&ure 1"J
C 'e constructed from 1 mm +nominal- thic7 austenitic stainless steel accordin& to EN 1<<88C2J
C ha%e a mass of 9#2 7& L <#2 7&;
2).85* The wire mesh 'as7et shall:
C 'e constructed from austenitic stainless steel accordin& to EN 1<<88C"J
C ha%e a nominal &rid si$e on the 'ase of 5mm I 5mmJ
C ha%e a nominal &rid si$e on the sides of
5 mm I 5 mmJ
C ha%e a load surface separated from the support surface '/ appro0imatel/ 6 mmJ
C 'e capa'le of supportin& an e%enl/ distri'uted load of 1< 7&J
C ha%e e0ternal dimensions of len&th +98< L 5- mm# width +259 4K
9
- mm and hei&ht +5<
F
R- mmJ
C ha%e a mass of +1#" - <#1- 7&;
2).8.9 The metal screws used in the test load shall:
C 'e austenitic stainless steel accordin& to EN 1<<889J
C 'e he0a&on head screws *SB 9<15C112 I 1<<J
C ha%e a total mass of +8#6
B
<#1- 7&J
C 'e cleaned# de&reased and dried;
2).8.5 The te0tile material used in the test shall:
C 'e a plain cotton sheet# 'leached to a &ood white and ha%in& an appro0imate si$e of 9<< mm I 12<< mmJ the
num'er of threads per centimetre in the warp shall 'e +"< L 6- and the num'er of threads per centimetre in the
weft +25 L 5-J
C 'e washed when new and when soiled and not su'=ected to an/ fa'ric conditionin& a&ent# dried and aired;
26;8;6 (ll items used to form the test pac7 shall 'e stored for at least 1 h at a temperature of 'etween 15 KC and 25
KC at a relati%e humidit/ "< M to 5<M;
NBTE; This re>uirement assumes that 'efore pac7a&in&# components ha%e not 'een allowed to e>uili'rate to the local en%ironment;
The test pac7 shall 'e assem'led as follows: QC place the wire mesh 'as7et onto the sheetJ
C distri'ute the screws e%enl/ in the wire mesh 'as7etJ
C fold the sheet o%er the wire mesh 'as7et containin& the screwsJ
[ place the wrapped wire mesh 'as7et into the tra/;
2).8.7 Store the test pac7 until re>uired in an en%ironment maintained within the limits specified for the items used
to form the test pac7;
2).9 4eterin! 'e8i-e
NBTE; ( meterin& de%ice is used to admit air to the sterili$er cham'er to test that a process monitorin& de%ice will indicate when the mass
of air present in the sterili$er cham'er is sufficient for the sterili$ation c/cle to 'e of uncertain efficac/;
26;9;1 The de%ice shall 'e capa'le of controllin& the flow of air into an e%acuated sterili$er cham'er;
26;9;2 The de%ice shall 'e ad=usta'le and ha%e a ran&e which includes a flow e>ui%alent to < ml8minC1 to 5 ml8minC1
of the sterili$er cham'er;
26;9;" The error in repeata'ilit/ 'etween 1< M and 9< M of the settin& ran&e shall not e0ceed L 5 M;
27 Do-.mentation
25;1 2ecords of tests and chec7s sufficient to assure the purchaser that the sterili$er has 'een manufactured in
accordance with the specification shall 'e pro%ided +see also 28;"-;
27.2 T&e 'o-.mentation s&all in-l.'e:
C e%idence of %erification of the cali'ration of all instrumentationJ
C test certificates and details of mar7in&s for all pressure %esselsJ
C certification that the function of each safet/ de%ice and its settin& complies with the specificationJ
C details of the settin&s of the automatic controller to&ether with pressures# temperatures and times ta7en for each
si&nificant part of the sterili$ation c/cle# e;&; chan&e from each sta&e or su'Csta&eJ
C when specified in the contract +see 15.*< the supplier shall pro%ide e%idence of compliance with the installation
testJ
C the settin& of the air detector if one is fittedJ
C declaration of compliance with the t/pe test and wor7s test +see clause 16 and ta'le 9-;
NBTE; This documentation is normall/ retained '/ the user in a %alidation file and is re>uired 'efore the commencement of commissionin&
and performance >ualification studies as re>uired '/ EN 559;
28 In%ormation
28.1 The o'=ecti%e of clause 28 is to ena'le the purchaser to prepare for installation# to install and operate the
sterili$er and to perform routine maintenance;
The information specified in 28.25 28.* and 28.9 shall 'e pro%ided either in one part# prior to deli%er/ of the sterili$er
or in two parts# prior to deli%er/ and at deli%er/;
28.2 Before deli%er/ of the sterili$er and with a %iew to its installation# the sterili$er manufacturer shall pro%ide the
purchaser with the followin& information:
a- installation instructions# includin& the o%erall dimensions and o%erall mass of the sterili$er# the floor loadin& at
each support when the sterili$er pressure %essel is filled with water# the clearance re>uired for access and the
masses of the principal hea%/ componentsJ
'- t/pe of electricit/ suppl/# e;&; ,C or (C# sin&le or three phase# %olta&e and fre>uenc/ includin& minimum and
ma0imum %alues and ma0imum continuous power in 7ilowatts or 1lo%olt amperesJ
c- the ma0imum flow and usa&e rate and the ma0imum and minimum suppl/ pressure for steamJ
d- the minimum and ma0imum pressure and flow at minimum pressure# %olume used per c/cle for water and feed
waterJ
e- the minimum and ma0imum pressure and flow at minimum pressure for compressed airJ
f- the total heat in watts transmitted to the surroundin& air when the sterili$er is operated in an am'ient
temperature of +2" L 2- KC in still airJ
NBTE; Ghen desi&nin& the %entilation s/stem the user should ta7e into account the heat transmitted '/ the sterili$ed load;
&- the heat in watts transmitted from the facia when the sterili$er is operated in an am'ient temperature of +2" L 2-
KC in the wor7in& area and 5< KC +nominal- in the casin& and the door+s- are closedJ
h- the mean and pea7 sound power le%els &enerated '/ the sterili$er# e0pressed as an (Cwei&hted sound power
le%elJ
=- the t/pe of doors and information on the necessar/ space re>uired for the mo%ement of the
door+s-J
7- the accepta'le ran&e of steam suppl/ pressuresJ
1- the appro0imate location of the reference
measurement point of the sterili$er cham'erJ
NBTE; *f re>uested# documentar/ e%idence to show the relationship 'etween the coolest part of the sterili$er cham'er and the reference
measurement point;
m- the ma0imum flow of water and condensed
steam to the drainJ
n- the ma0imum hardness %alue# the ran&e of p)
and the conducti%it/ of the feed water +see
ta'le 2;*-J
o- declaration as to whether the sterili$er complies
with .art 1 or .art 2 of EN 5<<81 and .art 1 or
.art 2 of EN 5<<82 +see 1*.)<.
Ta'le (;* Com'inations of materials
Hessel components for sterili$ers
and for steam &enerators
Su&&ested com'inations of materials
3roup ( 3roup B 3roup C 3roup ,
Cham'er
*
in
*H H
Zac7et
*
n
*H H
,oor in
1n
*H8H* H
*nternal cham'er e>uipment *
i
H* H
E0ternal frame for %essel 1*
n r%
H
Claddin& *,
i
1
- i
1
- w
!rame 1*
n n n8%
Steam &enerator inte&ral to the
cham'er
1E
m r%
H
Steam &enerator inside the
frame or free standin&
1)
1)
*H
1n
W-
Coated or other corrosionCresistant claddin& can 'e used where stainless steel is not appropriate;
28.* (t deli%er/ of the sterili$er# the manufacturer shall pro%ide the purchaser with at least the followin&
information +see clause 25-:
a- operatin& instructions# short form of manualJ
'- user instructions with at least:
C ran&e of applicationJ
C t/pe of load +e;&; porous load# metal load# ru''er load-J 7ind of pac7in&J
C total %olumeJ
C desi&n pressure# allowa'le wor7in& pressure and allowa'le temperatureJ
C description of the a%aila'le sterili$ation c/clesJ
C description of controls and indicatin& de%icesJ
C description and settin& of safet/ de%icesJ
C instructions for malfunctionsJ
C instructions for cleanin& the panellin&J
c- dimensions of the usa'le space of the pressure %esselJ
d- loadin& capacit/ e0pressed in sterili$ation modules in inte&er num'ersJ
e- a description of the sterili$ation c/cle to&ether with:
C the ma0imum operatin& temperatureJ
C a dia&ram of the pressure %ersus time relationship for the sterili$ation c/cle+s-J
C a temperature %ersus time record of the sterili$ation c/cle for each standard test load from the wor7s tests or
t/pe test as appropriateJ
f- the c/cle time for each of the performance tests specified in clause 1)5 ta'le 9J
&- information on safet/ details +e;&; doorloc7in& mechanism-J
h- maintenance manual includin&:
C maintenance tests and the fre>uenc/ with which the/ should 'e carried outJ
C electrical dia&rams and circuitsJ
C h/draulic plans and circuitsJ
C a complete spare parts listJ
C a list of the tools necessar/ for maintainin& and testin& the apparatus +onl/ special tools-J
C t/pe of &uarantee offeredJ
C list of ser%ice stationsJ
C &uidance on tracin& and rectif/in& causes of
malfunction;
28.9 The mformation re>uired '/ 28.2 and 28.* shall 'e pro%ided for a dedicated steam &enerator if applica'le;
Anne7 A @in%ormati8e< Re-ommen'e' materials A.I ?eneral
(; 1#1 This anne0 contains a sur%e/ and a selection of materials as a &uide for use in the manufacture of a steam
sterili$er *n the selection of materials# national re&ulations are ta7en into account; !or this reason# it is not
intended# nor is it possi'le# that the information &i%en in this anne0 should remo%e the decisionCma7in&
responsi'ilit/ from the manufacturer for the selection of an appropriate material with suita'le propertiesJ nor is it
intended to preclude the use of other t/pes of materials demonstratin& at least e>ui%alent >ualities;
(;1;2 Ghen selectin& materials# the followin& factors should 'e considered:
C the possi'le corrosi%e influence of the &oods to 'e
sterili$ed within the sterili$er cham'er#
C the e0istence of corrosionCpromotin& su'stances in
the sterili$in& steam or coolin& a&ents +e;&; free
o0/&en or car'on dio0ide-J
C the possi'ilit/ of formin& corrosionCresistant la/ers
at surfaces;
(;" Ta'les (;1# (2 and (" illustrate the com'inations of the followin& materials num'ered as * to H); E0amples
for the materials *# n# ffl# *H# H and H* are &i%en in ta'le (9;
* Stainless steel
n Car'on steel
El Car'on steel# clad
*HCopper
H (luminium# aluminium allo/s
H* Copper allo/s
H** Bther
A.2 1i#es an' #i#e,or;
(;2;1 1edia comin& into contact with loads:
a- steam for sterili$ationJ
'- deminerali$ed waterJ
c- sterile airJ
d- condensate;
Ta'le (;2 Com'inations of materials
.ipewor7 for
circulation media
comin& into contact
with loads
Su&&ested com'inations of
materials
3roup E 3roup ! 3roup 3
.ipes
* *
*H
!ittin&s
* *
H*
oose flan&es
n n n
!lan&es for weldin& i i C
Collars +weldin&s-
i i
*H
Hal%e housin&s
i
H* H*
Hal%e cones and
&as7ets i i H*
Sensors
i i
*H
.ipes for pressure
&au&es i *H *H
.ressure &au&es
i
H* *H8H*
NBTE; To pre%ent transmission of noise and %i'ration#
elastomeric or fle0i'le metal connectors should 'e considered for
part of the sterili$er pipewor7; Such connectors should 'e
su'=ect to the same consideration of suita'ilit/ as the pipe into
which the/ are connected;
(;2;2 1edia not comin& into contact with &oods:
a- steam for industrial useJ
'- coolin& waterJ
c- drain waterJ
d-compressed air for control purposesJ
e- steam and8or air under %acuum;
Ta'le (;" Com'inations of materials
.ipewor7 for circulation
media not comin& into
contact with &oods
Su&&ested com'inations of
materials
3roup ) 3roup Z 3roup A
.ipes *H
i%8n iwn
!ittin&s *H8H*
n8%i )1
oose flan&es
** n n
!lan&es for weldin&
C
n n
Collars +weldin&s- *H *H *H
Hal%e housin&s H* H* H*
Hal%e cones and
&as7ets !H* H* H*
Sensors *
i
*H
.ipes for pressure
&au&es * *H *H
.ressure &au&es * *H8H* *H8H*
Compressed air pipes
for %al%e control
%n %n %n
NBTE; To pre%ent transmission of noise and %i'ration#
elastomeric or fle0i'le metal connectors should 'e considered for
part of the sterili$er pipewor7; Such connectors should 'e
su'=ect to the same consideration of suita'ilit/ as the pipe into
which the/ are connected;
Ta'le (;9 E0amples for the materials *# **# ***#
*H# H and H*
3roup of
material
Standard 3rade of material
*
EN 1<<88C1# C2# C"
I6CrNi1o*115C12C2
I6CrNmi89<
I5Cr118C1<
I2CrNi1ol5C12C2
) and )*
EN 1<<25
E@2BNB21 95
prEN 1562
!e "6<CB!N I 1<
CrNiTl 18 1<
ENC3Z1GC95<C5
*H and H*
prEN 1652J
Gor7 item
<<1""<<8
1
-
prEN 1982
CuC,). 3C
CuSn 1< ?n
Cu?n"9.'B#5
H EN 55"C"J EN 55"9 EN(G(l1&"
1P
*n preparation +CEN8TC 1""-;
Anne7 B @in%ormati8e<
S.!!este' ma7im.m 8al.es o% steam -ontaminants
Ta'le B;* Contaminants in condensate and
feed water
Condensate !eed water
E%aporation residue O 1#< m&87& O lBm&fl
Silicon dio0ide# SiB
2
O <#1 m&87& O 1 m&81
*ron O <#1 m&87& O <#2 m&8l
Cadmium
O <#<<5
m&87&
O <#<<5 m&81
ead O <#<5 m&87& O <#<5 m&81
2est of hea%/ metals
e0cept iron# cadmium#
lead
O <#1 m&87& O <#1 m&8l
Chloride +C1C- O <#1 m&87& O 2 m&8l
.hosphate +.
2
B
5
- O <#1 m&87& O <#5 m&8l
Conducti%it/ +at 2< KC- R " =0s8cm R 15 =0s8cm
p) %alue +de&ree of
acidit/-
5t o5 5 to 5
(ppearance
colourless
clean without
colourless
clean without
sediment sediment
)ardness +2 ions of
al7aline earth-
O<#<2
mmol81
O<#<2
mmol8l
NBTE; The use of feedwater or steam with contaminants at
le%els e0ceedin& those &i%en in ta'le B;* can &reatl/ shorten the
wor7in& life of a sterili$er and can in%alidate the manufacturerDs
warrant/ or &uarantee;
Anne7 " @in%ormati8e<
Bi$lio!ra#&/
EN 559 Sterilization of medical de"ices : 0alidation and routine control of sterilization b# moist
heat
EN 556 Sterilization of medical de"ices : ,e.uirements for medical de"ices to be labelled 'Sterile'
EN 55"C" Aluminium and aluminium allo#s : <hemical composition andfoi/m of wrought
products : &art 32 <hemical composition
EN 55"C9 Aluminium and aluminium allo#s : Hiemical composition and form of wrought
products : &art ;2 @orms of products
EN 569 &ressure e.uipment : (erminolog# and s#mbols : &ressure, temperature, "olume
prEN 868C1 &ac5aging materials and s#stems for medical de"ices which are to be st#lized : &art 12
+eneral re.uirements and test methods
prEN 868C2 &ac5aging materials for sterilization of wrapped goods : &art 82 Sterilization wrap :
,e.uirements and tests
prEN 868C" &ac5aging materials for sterilization ofi"rapped goods : &art 32 &apetIfor use in the
manufacture of paper bags (specified in &an ; of this standard) and in the manufacture of
pouches and reels (specified in &art 6 of this standard) : ,e.uirements and tests
prEN 868C9 &ac5aging ma,teri,als for sterilization of wrapped goods : &art ;2 &aper bags :
prEN 868C6 &ac5aging materials for sterilization of wrapped goods : &an J2 &aper for the
manufacture of pac5s for medical use for sterilization b# eth#lene o%ide or irradiation :
prEN 868C5 &ac5aging materials for sterilization of wrapped goods : &art K2 Adhesi"e coa,ted paper
8or the manufacture of pac5s for medical use for stetilizatioi% b# eth#lene o%ide or
irradiation : ,e.uirements and tests
prEN 868C8 &ac5aging mateii,als for sterilization ofi"rapped goods : &art L2 ,e-usable sterilization
containers : ,e.uirements and tests
prEN 1562 @ounding : =alleable cast irons
prEN 1652 <opper and copper allo#s : &late, sheet, strip and circles for general purposes
prEN 1982 <opper and copper allo#s : -ngots and castings
EN 1<<25 : 199" $ot-rolled products of non-allo# structural steels : (echnical deli"er# conditions (includes
amendment Al 2 1MM3)
EN *SB 9<<1 : 1999 Nualit# s#stems : =odel for .ualit# assurance in design)de"elopment, production,
installation and ser"icing +*SB 9<<1 : 1999-
EN *SB 9<<2 Nualit# s#stems : =odel for .ualit# assurance in production, installation and set?"icing
+*SB 9<<2 : 1999-
EN *SB 9<<9C1 Nualit# management and .ualit# s#stem elements : &art 12 +uidelines
+*SB 9<<9C1 : 1999-
EN 96<<1 Nualit# s#stems : =edical de"ices : &articular re.uirements for the application of
EN 29<<1
EN 96<<2 Nualit# s#stems : =edical, de"ices : &articular re.uirements for the application of
EN 29<<2
E@2BNB21 95 $eat-resistance steels : (echnical terms of deli"er#
Gor7 item in preparation b# <*4)(< 133
<<1""<<8
Compliance should 'e tested in accordance with ac7nowled&ed anal/tical methods; ( method '/ which a sample of
condensate can 'e ta7en is &i%en in 29;9;
ist o% re%eren-es
Anne7 CA @in%ormati8e<
"la.ses o% t&is E.ro#ean Stan'ar' a''ressin! essential re:.irements or ot&er
#ro8isions o% E2 Dire-ti8es
This European Standard has 'een prepared under a mandate &i%en to CEN8CENEEC '/ the European
Commission and the European !ree Trade (ssociation and supports essential re>uirements of E@ ,irecti%e
9"8928EEC;
G(2N*N3: Bther re>uirements and other E@ ,irecti%es ma/ '/ applica'le to the product+s- fallin& within the
scope of this standard;
The followin& clauses of this standard as detailed in ta'le ?(;1 are li7el/ to support re>uirements of the
,irecti%e 9"8928EEC;
Compliance with the clauses of this standard pro%ides one means of conformin& with the specific essential
re>uirements of the ,irecti%es concerned and associated E!T( re&ulations;
See national foreword;
Ta$le CA.l "orres#on'en-e $et,een t&is E.ro#ean Stan'ar' an' E2 Dire-ti8es
"la.sesDs.$-la.ses o% t&is E.ro#ean
Stan'ar'
"orres#on'in! ERs o% Dire-ti8e
9*D92DEE"
Remar;s
95 55 )5 75 85 95 1(5 11
1
95 55 )5 75 85 95 11 2
)5 75 85 1( *
95 55 )5 75 85 1(5 11 9
5 Not -o8ere'
95 11 )
95 55 )5 75 85 11 7
95557 8
6eat.res o% sterilizers s#e-i%ie'
,&i-& #ermit 8ali'ation to $e
#er%orme'
95 55 )5 75 85 95 115 1*5 275 28 9
)57 1(
115 1* 11
55 )5 75 115 1* 12
125 275 28 1*
19 Not a##li-a$le
BSI Britis& Stan'ar's Instit.tion
BS* is the independent national 'od/ responsi'le for preparin& British Standards; *t presents the @A %iew on standards
in Europe and at the international le%el; *t is incorporated '/ 2o/al Charter;
Re8isions
British Standards are updated '/ amendment or re%ision; @sers of British Standards should ma7e sure that the/
possess the latest amendments or editions;
*t is the constant aim of BS* to impro%e the >ualit/ of our products and ser%ices; Ge would 'e &rateful if an/one
findin& an inaccurac/ or am'i&uit/ while usin& this British Standard would inform the Secretar/ of the technical
committee responsi'le# the identit/ of which can 'e found on the inside front co%er; Tel: <2< 8996 9<<<; !a0: <2< 8996
59<<;
BS* offers mem'ers an indi%idual updatin& ser%ice called .@S which ensures that su'scri'ers automaticall/ recei%e
the latest editions of standards;
B./in! stan'ar's
Brders for all BS*# international and forei&n standards pu'lications should 'e addressed to Customer Ser%ices; Tel:
<2< 8996 9<<1; !a0: <2< 8996 5<<1;
*n response to orders for international standards# it is BS* polic/ to suppl/ the BS* implementation of those that ha%e
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In%ormation on stan'ar's
BS* pro%ides a wide ran&e of information on national# European and international standards throu&h its i'rar/ and its
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This does not preclude the free use# in the course of implementin& the standard# of necessar/ details such as s/m'ols#
and si$e# t/pe or &rade desi&nations; *f these details are to 'e used for an/ other purpose than implementation then the
prior written permission of BS* must 'e o'tained;
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