BRNTSII STANDARD BS EN

1174-2.1997

Sterilization of medical
devices -
Estimation of the population
of micro-organisms on product
Part 2. Guidance

a
mNHem^s 4illms d@Ruc,n uw
 i

ll7+2.1997
\,

Committees responsible for this 'a

British Staldard
TtcpeFdjonoithGBdE;hSddad
crr57, SEildion oi mdc?r devic€, uron *tuch thc forbwn€ bodje wae

\
rs$cidion of Bntnh se.recac riddiG

Agcilrtjonof!\eDritishPh3ntsu€]IndNuf,
BriGheaB-ihedc!'dRclPiEbryEqui

FoyrPh3macuii.dsdelyo.c.edBdfu
 l
BS EN 1t742 I 1997

Contents IRU
SIRII.'
rililililrr|llilllillll.|Ilflr

.r*/
ir
EN 117+2. t997

National forerMord

lnsH bsu,s" vsid or EN I l?42. t0e6sdu ti.n ot ned&,t M _

4nw@ aJtu Dop^tia qltw@
pubGhd by de Emp€d c.Imk for sbdddion (cEM

EN n?+r: $96 BSEN rI74 Sbititutieqllzljhldnik

Esttm|imol L\. prptntio\ of ni.rurean^ms on ptadrcr
Pan|:M6nqar|fuls
compriance ,ith a 3drist sbndsrd

t
 ET]ROPEAN
STANDARD EN 1174L2
NORMEEIIRO?fuNNE
ET]BOPAISCI]E
NORM

Stedlizationof medica.lclevices- F6fination of the population

of
micro{rganisrs on prcduct part 2: Guidance

;,-:)
Stedllsationds di?osidE n4iiou\ _ Fsrimdion
de la FDuldion de ni.tutlmm6 su u
podui -Pdie2: rim6 dialrics
$enLs:tion rcn Medizinpmdutren
_ S.ldrzrr
de Populdionvon lt o@rsrdtur aur ebe;
Itcluld - Ten2: Leidada

I.l1f.- .*.+g ,1 rp.dled oy.r N on resoj0re..L^ rmbe6 {e

* '-'* shdd d" qb of 3 djonJ tu d.rd
ffi"":::".i.lHi
UDlro-LSL 40 b'br oShp\
e Csml L Furir or b sy cE! n "mb".

til::#**,,::""':fllffi.Jdlodfild@L"knfalse'Lfuh6U.
:El\ n.: b"h {" ,}" udonrr tu&d_ omiL of Ausq Bars!n . emr\
r, q L** bo;s \e,r.... d,
ffoM,yPodsd'sFn's\Fdeilsq

Euop€& comiec ror sb.Lrdj?:rion

coftc Empden de Nomdjs$on
Euopi]i*h6 Komire fif Nomug

cenrar se.red.inL ruc de sbs

19t9O.6Copraighrqned b cEN mcmbeF

 2
117+2 : lSS6
\
a

khdc,r Coftnitue cENdc 20.1,

sbdUaion or
medior dsic6 6e scrcld of vNch is I'cld by

mdrlrb sivcn b CEN/CENIrLICby de Euopa

or EU Dletiv<s) {'loFdionofthe|ahoFlory
ror rebiioGhip wi$ EU Diftdves{s), seeinromativc 4'2Equipmentmdm&rials
tu--r 7!\ rNch is u in48ri pM oi thG shdad

Gi r by endoEcmer! t d'e bbsr bv M4 ls€7, md

connicbg narioml tu'deds shal bt dfidm d

c \bridrion ofbiobuden e.niiqu*

nncrrlsrGG (bioburdcn)on prcdud b be
scdncdol.ner'!@[.,io[EN1174hAbes 6-2 v,li.ldion ol bnnique for Emolzr or
p.eFedindreePaiq4fonoE:

EN 1174 sttit;jdiaa alnzttnt dtuir6

Estitutibn d! 0E e.padb E
fuim.a|w^ifudpfun@|
Pe|:fu4iM
PeL Ardme ?3 ftnd an {sG ror pMs monib.iis
Pd:t tjttu b uE n bds Jor tutitntin ?'4San'IjngireqPqlbrpmcs
a:lnim bi. Iasid t td-\ai!tt6.

dd ring 6 tle cEN,tENELm Inbnd R!e'n ios, Annex A Culrondve) Bib[osiphY ;;

ftY'jomr tutuds orgmt:tioE or the touotus annex zA (infondive) claug offiis
comtie@bosdtoinplcmedL\isEWpg Euopea stu&rd addehg send
shd{d Asdi4 trelsim, Dcmdk Finrm4 FYarc, requnsenb or o6\d prcvisioN or EU
Cen4 CreG, leldd, LeLnd,Idy Ldenboug,
Nedrdeds, Nos4 Pohgal, spain,s{dcn,
Sq,ikdhd dd iha Uiicd lJnSdom.

micru.saift on pFdu.t (dE pbpdfon 6
efrtudy rnoq e tne b@burden)d6g hs
DNllT.ll.InisPstofENLrT{conbiEluidaceon
iheinplemenbiieofENllT4lMethodsod'ertlre
s@8ireni'thesui&nce@beEedb[66e
etrdic n' d'ievn'e snpliae uiL\ thc
1r'is Pd of dris E@ps sh.brd povidc suituc
ENrrTatI!caineddFovidiJ'gabeh..
ali- sdeshdi'\g ar EN rl74r 6 e[ 6 si:iins u
inpl.mcndngi6rcqun.mcnbThcgui&nccgivcni5 .ne Bbllishme of ur Irlo@ry qldry q<em nd
not ur{ded b b€ ee\,stiv€, but b lig}'liqlr lrp sdncicn. aufionry b sre Llut the $em is
r cheklH lor ssn'e omplme MLt EN tlruI.
2 Nometive refe!{ce
11r!' Emtl€a shdad incoDoe, by d&d o!
zlprcplie pl,c€ in lhe @ dd d'e public4o6 de
lis€d here.ne aor d.ed ret@ce, $bsequdt
publidioBapplytoihj.l}epenshd'do''ry
EN r\?4r) r$6 Sbitiaatxn af msJtat.taka -
Est tuin a! tlE parJutalka aJ
P.d]:R.qu,mb
defniiicrc giFn in EN 11741: Bs6 ,rpty
InorderdE|dEddobbjned6'0[oerlontring
bioburdenr,6dtuio6 {i[ bc rcliabremd
,.
EN 11742 : 1996
a ftmb lE6oq sl'odd dEeroE be ma2eed md
tllenedicdd.vicqlneopedionollnoLlnomry
shouldb€frbjnd'emauffusqu,]iBqsemIi
yc.ofid?gad{
.$yh|odorysl'olrdbemm]udtop|o9idinga
qualirys.Mce rd dB omitnmr sholrd be
docmcnbd E a qu:'lig poli.y lhe ljos or aud,onLy
fte or)Mion or ihe l,botury sho'Id be subjct b
reg:nd inhf,ur udi6 tlle 6ul6 of d'c '!di should
!e d(mmbd ad Evie*ed by lne |rbo@ry
finine. inromdion on quii4 nm€e'netu 6 2ELble
in EN 29001.tN 4500IoudinB rt@nfrlnb rdr a
labo@ry q'r:nry$bn ad pdjcDrar rquilmmb
fo. qu,lig r*tu aornedror dsc
spsiEed in EN 4600rdd lN 46'102.
C.frputd maybe Ed in lzbonbn6 ror both died
$dindidcolle.tion'lroctrusdor$od€eof
appLdios shodldbe conhned
TtecompubrskmheslEdd
in ls ot Mrdw€ md etoie, md my chmg6 in
eiL\s of ih6e asls sho'ndbe d(ll]mened md
subjd b 4p6pri& alpld
a) ne appuedoE $ftsffe M oi $e .ofrpucr
1]l sllle shodd be acephc€ r
pur hb sMce Gc. ror e@de ISO9000J)
\lllencoimedd$fumpack.gsnpuclE!
d,* paclcge srould h,ve beenprpffed mdft .
qu.riq sy*m 6 dcnibed ii IS0 9000J
 It742 : 1996
$dbploeduEshoddbedcwl@edbGn
r) dtuerdion on dflelopms! hctudhc rrE
!) Hords or aaephce Bins ae Ebiied;
E modm.dioN b p6F,ru m dmhcnhd;
4) cnmgs b eqdpn.nr ae docmcnhd rd
'n*.onhh sho'ndabo br appled b 'y
s +rvd pmctuB Llhichorydc, rdln:te, subjec!
\'.bsdddorotner'narnmdj
er!.@da{v sbrcd ,l{4 sh'utd pand rcdie!,] ot
oncinaldakcnb6stccialNcedlElola.hih{
1.2.2laboru.a4 eq!4 nent
'fhe should
be 3 sts.m ior idmtjfyine ae
Eqnipnmt d'a! d6 not nqirc sribarlon sho,jd be
Any equpmmt, or pd irasr, $.d com6 inrt
cooh qh p6drd, ctumqnenj4
4.3 Microbiorogid nedia
Anmimbjo|ogiGln€di4edefuen
n. u dE ca@ !\en srili+
'rL),r'r
of n.mbroroc'cn mcdrm b $pFo(
er(r$ or me@rgffi shoutdb
ts omollv d4ed by pe.romins 2 elydl
doc,i4 of rc nuobe6aeMQn L0&d r00
corory.foming h6r of serrftd m&@@jsre
uD@ $pf.d 6 e dqnLen n Phlm&op@d
5 Seletion of technique
freg€qucnceofkcysb!6ofthebchniaueforthe
di@iiono.nidobfulcbnhidi
SA]UPLESEI.ECT]ON
corrtcTloN oF n EtilsFoR,trsr
,I'I{{NSFERTO TEST
LA3ORATORY
TFEA?{INI (tr q,,jred)
TP"ANSFER'ID
CUTI,TE MEDILIiII
cE4nacrERtL,.lloN (ir 4prop.iab)
NTERPNSIA1]ONOF DA?A
Theindividuzr4$oEibre for dE conducioatucn
6dJudo6sho'nd@howledgeoffuaw
m?lrfu, onponenb, ruuractuhs mnlmenq
*tdalprcpriaiefreL\odsforgchof$esbg6
as indica&din dE heodudron boEN u741,
d4elopnent ad !"1idadon Do@endig dr*
dGideBtioN, md ae ntion t6 for d€isioB hren,
I|d'ebiobudcn(fu&isbbebedbsbllilh
dn?qy dre ere or @m b qenr4 .ondrho6
rcBdc€don shodd be eq b hd!d4 prbgDs
Idelrly biobuden sho,id be BrimaEd ro! ach
pmdrr on 3 Re'rh b66 Ho4e4 thn rlrc wde
delyo'Fr6d!GlwU'IMcdofunusn:]l
b?&h6, d'is G nor alws p@.jc.Ite md, ir strch
.imhg.nceq plodud my b€ so
oi pbdlct O!€ ed qui!€lenc ol maufatuins
Thedionare for n,rgding pmdu.6 hb such
Mchods ot b}jng rd ledring ffp16 sho'nd be
 EN 11742 : 1996

cencd& njdeemisG e tufaEd aom dE 6_2.:ts ohP ri.s /r.q uenq

ibm bcing ed, or a ep@r€nre podon de€oi Thc trquacl of biobud{ (sMon shodd be

huchamenb@filkrwhfhEibdlp|rcedona
curtue mcdm or direcriyptded onb cdtue a) eb rDm psio6 biobudendimaloNl
b) drc € b b€ fradc of tlr dimc;
m.bdcedforsulf4esmo|rruisN6'2-{'7 c) hc mmGctuing prccs6 E4

R{ovcry of ni.I€rgmjsm ftom prrttrcc sudacG e) prcductionfqumry ior ftc pmdtrcq

.€mts b uei e^trd bysubjetu gJ6dio6 in biobdcn 6ril]e

lh$'JfumlqlJrntrthelqu smplhgroyb€pcdomEddre4ocybase]rdl

biobudsshJofuJlhul'i4fK\duuig6e
]
,) *e prcdrcr ar mdon pdor b sbrirztion:
b) de !rcdud dd is nor dbnb for s,re whjch bioburdendcveroF Gee*o 7.4)
n'ay be a scD! or orhNi* Rjecd poduc. fte requmry or bioburdend@ioN drdd anos
s@nar Eidioc, mad4ruine .rDi€s d chbc6
+o,id En 5 !r@rr a !.s,bh de prcd!.i a rs
prsscd rbr sF,{idjor rf 'ne de6,on 6 oro r.
utue 4jdd Foduct, n sno'jd b€ bran so dELrhe
prcdud h6 udellone ar @tial sbse or
prcdlcddi'includi4posib|eclainchdpak:€ins ]]re dege ol .dn6ion of nitur8Misro b sMr6
mic@€alm inhlred ad orhd;.&i* o€s.
Ppenb he mored6i6bre srle e.g.lubri6B Tne onain or $e conhtu; nl
Dirr{mt slGbei6 tuy bc empror€din rhe setdion :rso intuen e &e degne otadhGioh 1b Emde
micreiS&itu, tlrdents emptot
purpcej srd 6 v,li&thg d@jng or &ins tuinc bsefid wiln sme fom or DhFi.t foo or
dner suda.e sdjnc A sodatui mv be @d b
6.2.2.2 vnenaer ln(iobrq dra bjoburden cnr]IceEorerybutirshou]dbeBo€n'eddE
dnxjon sholddubre lne vhole prcdud annouqlr sdrh'6 d hjSl' orcenbtioN m
fr'celgmi$ (&c ale 6.2_61.
a.omocd i^ aqiblle hbo@ry srau4 rrfthcefuin.d:ls,$ftmi.h€aisfunav
ln m.u $3 biofln. A biofiln is a unqre hcm
ue ds ftbe x |lrgea lotuon dbe rodud 5 h
psLb|.$oddbeEedJdt,Le@donshould]xow
qr ich adhe€ sonstv b rd&6 M.rErllmcs r
dcompleiiono.tltdimdion.ihebobudenoi6e
whorepoduct b be dina!€d Tre.eforc, {4fut
wcdd not be erT@d comonlv in Lre l@u&cft
of n edicrt daic6, stdFuSnin cednn i6bnc6, for
etude 6d m@jJrs of min,r odu. b,ofitns mr
622'l'nmshpLiuform,i.zthcbrcb&ddL be rom€d b sch ufucq oEidetuon shodd r;
c{es]ouldbeb}sdaL\epDdUGmo'fucd e'en b re pobdal for bbfdn fofr3lon ad ir
shou]dnoibesmgd,\4ftetehen!mgthod

Ids, (m shoL'tdlle blen duine llmouLroE or

obbjn.d duinc ..:rjd.dionof &e ftmov?r khniqu.
G.s.i6ido I rhinl flow obind) in ode b doid qcatedl'chmic.obialcou6agRoRledduiu
iep.ddv. rdcnt Gca6.2.2)

dweLkeLybaffEtdl.isnirjtvormicelcMisre
s!!|ia\m6NeO\Dmn{i6io,G.!!!@
 '/$N t74.2 : rS96 \

rctF9ed6baedisnptid&ddgdlo|
*le6,1€ameuodJL]devtwBs
6.2'4As]e4viktuiuml916'bn6
n n.,hod rhe dme
n|rus6nc|gcbedmo,darmrft@isfu
#cr (Kiptus o r', or@, &to^r r ordq
pDoo( u@r cr G.s disinrcFoo
rcesJ'l} ftc FMrc! d Js€ln&aed mrnn m\ depcnrjnsoi fte opcnb. cras beds or a acnn;d
!s|byrlolerycrTilienrl}!5u!oiJddedd.!s
6gtF3 d 'rdid rmn i]]e c rcnq ma b. Lrd5''oledHqllr'}!ln.JiJfulEndor'

T0orpos|'FdnilFbdlmneJfuG
h sho'rrdbe noteddui dr additionof rtas bads \edl
! Erig 6 bc dodo4 d qr. mcrea? uc sun&e mr b which nidiHllmjrns

'&m&U6.dO!{b"i}eo'seds€nr,otr
osl@ m nhbc6 oi mi.@/:M ud shor,td
Tr'e .ontu4 b ue G.4 dre rimeor nie ed de
speedd whjcn dE mixe € s{ sho,,rdbr d;nnd fte

appld ']uu,rlv Ftuh q.rR rabrlj& tne

m€hodbai.kmdsp|ebFrlombuiBo'v
Fdd€ ople tr 'l]e br€ forcfg d e crmd uuulh su6|e.orsnDxil*wdrcgubr5uJr46
This derDd E pn.uttuty subbh for ea_ fibm6 ,rne?|umta,as.dL\bnghd]aI
Jool3e&nth&j:]sbdiloulLlL€rcUd|c
|d.4roki]15}h]chqddpm(@Lleb&'IoI rrcoua uquo bw my e bdred br 8mery d
effpb deuc6 rcntua
pumpng.affi€y'nt pddldn4 b€dkd Md
re€d6 f pmcu&d\
hcdr4(bfrp€dh']4@d
ih. rine of rdent nPdtrofonb(b€srcn|]redt
shoLddba dctued
- :c nedrod m4 yrerdr -u!eN6n hrhr a row
\:ricscaron f mj.e4il65 b€6e d 'ne
rur,ft0 brB€ rcr@F de lsr em 6_2.s Dniabsn.@ (b1,tu|inr)
$cn a membHe ithiion Ge6 2.6.2ro.Dou
pb6u rk 5.r.6 ?r nll be qUH.o;sb*emr
droppedlor a @itd rime tr sBified rire

n]edien6inneFdn:kroqrc|meo|el[rt mopo$bFon,€ebUemj(hq]fufu]rb
qtm:tu6ret*r E dier be v69trd conbnB

srbonc) in qlxch ktu e ptr.{r n r

sw}loBinof rherbdr . .n,tEu:Iynoued
uttuonj.
h+oddbedefiredcoN]dedd$o!ldb€E\m
. mrMg se nrnbeof LkL!
b be lrftsd

l}'jstiemodispdict'ra|ys'ndbfol$|id
d.d^aJft"
$:b is dcn hnsfened b a tunor &ru;
Ftuora4v sce emtus etehnj. @mmronE [duh tud aeibt.d b cmde ,ir€fs
 EN t1?t2 : i996

Arbtuvev n' &e ce orsorubre

sw,rs, dE s*€b is
dMldhlbufieglldonolli@idmedim'me frlmglidsulfe6,drehm4o€dmo.,sudIdl
idtuc su$*ion js dFcd br frrdion, pbc
tlu* ad {uuenb comonly 6ed include!\ce
subseaEcfinmed'odorsD[ngireg]j?ny
sh4ied or .ehrivelyi@csibre 34 rrry ft arso
€Fn whena lrse .m ha @ be smpled_

rh emorc.,tt dhr, d3x marH,s,lrrsfum

mtlwrgm^cwhichrecol|ectldm4b{one

.dturc n'edm (d a nfuq kmpmrEe or45.c)

4plable whenL\. biobtrrdenis roe ad Lre Drodud

Trr" Dd .iopin! d klrs on surr:c, ,rcri^g of

rcbflB,bea€dbbd}5drv''soltofln.:gs
md he rcibitity of ddobic lodioN m !@nrjrl

conbd phb o. std6 n ntu by whjcn $[dmed

cdfuendMeb€@liedbaseewiirl!\e
hhrion thd vi:bre ture@isG lilt adneEb lnd
sunae or r]le medim TheptrE or sridem lnen be

a suda(h suchs lolj4orbe s0 iEy b€ dded b

s!.hsF6|d€dreadsl4eof
xa<uG ae &ectlv relikd b L\e 3o r codi r d[i rdqi4b gcn Erry @d detsndjneuDon$e
aa1. sletrc 4plidion. Tte appDpri@ oncmdon b
beRdwjlns'@dcu]z!dientshaurdbe
ser{Fd cetuxy bmR flhh€ ror *cu
5.2,6 Traqle. to cukuft ^.druh

Duing broburdenedndion, eluenbnay be wd b

rcmor nl]@rcds n m &e p&duc! lrrElod
nicIHlgeisfo.mmediona
enpbyed b obbin suslisiore conbinins
'Ite
mbft ol ine erumb ad dilumb a b.E a
me od used ln ele.ring I diluenror eluen!
coEidadion shouldbe givene ib compGi.ion
(e.g .oEtibena Td iheir .onccndjom, osmoteiw
d pH) rl'E comoosid.nd'ould be su.r s*
ds@'€djsc in &e eluentwrncna be *nnred
lor Ine plrrgce or viablemicl€rlejsft by one oi
ftemdno&ddbedin''2.6'2b5.2'e.7below
aggregd€ o.nic@I€aitu md lneftby mdu.,
demieergmisNftomL\eilemmdei'6rMr.o
'MpLsu.[:ggEge'butin$m.ilfucca
sepzdehedm4b0nc.ess,ry

)
 a
1774.2:19gti

r ni@bicid.l or mi@bicdc sbsh.6 m

pGm!hdreellent'lllenrybeEdfedbo
in€fetve @ncenbdon by dnudon,Emorcd by
bmpel@ nor medi'g 45'c wh
micobicid.r or friqobiGdc ibtu.6, ihec.o€, b elidtry o. a pbe, eg. PEti dish T.e pou plab I'
hcubd.d md tne coloni6 cohbd
In dop6ng u enmedion mc$od Pod pldinS d6 not eptu micffilsfistu rdn
.omb, cosid{alon sho'id be g€n b lne upper
m pEen! the co6ide€1jo6 oldined in this rc8ard

ea.n vjlblc nic'F.ga'ism c ableb @r5 iEe|f a

a vliibk .olony wjL\our beingallRted adveEdy by i6
js on tlt su'{&e o., sold medm 6he a
ln a.uition, dr pr66ce or a,b6 nay prevot d'e $F:d

- ,:n.2 Men Jmre nbdion

Lr g.ned, neibtue rJtuo\ rono\
of dre mter on a!.olnab g!ow& medim io gn?
.onbnidion'Membm.fir6haviJ'g4!Io!n& Lhecoreiddio6 oudhen r dis resrd
poc st4 &o s$nla or remNinr mio€remism F6{!
in6,2'6.rwr:rs.,pply
nDmdrccludt*hi.r'6lj8sdfun8hddAfltel
oiporesia0'45!risgenedryu*db|eie 62.6.5 M6t Pn|oue ttufi{ (ttPN) tut\td.!6

ruy b€ plr€d on eir]'d m rga sudaceo. r when z suficieii rclMe or elueniis aEibble, , EIee

$ch fid a lrdion or L\e inocul&d m€diadoe nor

F[duevnibbgbdon$bsqumtij'NbadolA
Mdbde tudion h pdicuL.ly @tut for sbtsic,l asssmmt of the nmb€ ol drludoG
ffri<r@Igann6 sho{ing gDwn pmvids a din& ol L\e odsiiil
FndanonjsU*fulvhmiheli{'ndsuisftbc nmbeto|dcleIFJGro'1h51q'oreffiplc
@etd ol conbjniis miftbi.idrl or nicobidhic DeM'nz).hac bfrn Dmducedlsine 2pp@n@
suhtuG, be6c dre fricdllmism @ remoed shilsic,lNmplioN9dEtdEl{odPsbable
Nmb$ O1PI9 ormtlmquisG a b. dnedy
I-;pnor b inobeon Howeq somee!6 or
r*lnbae mv absod tr EL6e $btu.E wtri.h IPN nedrds e sirple b pedom, bui Lhe'age or
co!'dinnibiidEs6*dormicl€4fi]ssd$i
is im@tu! tht only frdbtue filbc $ihble ror lidibd rd d'e sbtisicr b6b for the ierhod n.r€
ir moa 4pop.iaie ror SeneElsmcnt Etncr $m

6ua{yrequi.edcdeshoL]rdbc*ed*dbarcid pEeqL\eco6ideatjoNouirinedind'jsrcgad
d @E dGbtid
or daM€e b the membme fird
Membtud fildion of elmn6 conbjningnl'fu of
udnc m tubdic dcviq d &uot or, sEpmion
or fric@4anif, is spP:d on lne M4e d $ud

h a spinl ftck fion $c cd@ ol tne cultue plateto

 t!{ r!]{i:fi;

Ali.r di.brc inoh.doq Lle oIBoim {rut in dE

ortsiur s6FGion is sblGhed Nin4 a Ddicular bb{.:]jbded:€;dco|onycou|boiem4o!
courinc eid md coudns iRMqu rinju]doiofd]*E.hI@6Bdellr:tive|yh€h
n@bc6ofdrtHIHijroihJn(dbba

Tn. spinr pradnehhnjque h6 ben sroq b gi€ 6.3 Sclection 0f nedif, and incub

sp@ng cdriqus Dueb dre d6ign or dr

4pfuddtnceofc4ix4hbiMhdsm?rl !) No single .o(bidion of nedim ad hdtl3don

uocddg s6pe6ioG a. ve[ homasenjssd nicrMlg&ifr:How4eqsom.conbidiocwix

"iich
hdfteflon,€gregbo|n:rerial
5.2.6.7Me Pm\ouz Nmbn IM?N) mnbd.af b) varidaion crerc66 nay lqire dre Go of a
,Y)
c) Dircd piari't on seledjre medn mav nor .emir
5 mctrndrros rd L\ef b.4 <u.hadjdblron oi gowinofphFblocicaxysd*dddmaged

inrodu.ed dnecilyin@dE cLntuemediun do nor d) rre sre.ioi of c'itue condirjomsrourdbe

For som. poduc6, it @4 []ely tu@bd cm;tuudon su.6 ;
n,ay bc apptuprtle b i"doduce morc L\fl dnc it m mcfuoid'emido.Igal!;rolikelybbe

Ir micobicidzr or ni@biMdc subshcB m Exdpl6 of nedj! ad indb2tion cond iore e

[*d h bnle 2 (se also.1.3]
in52'6rw&,ty Y'4 dd noulds nay b€ c'ntued by cincubdion or
62r oth.r n thok o! dete.ttns ,e6bic b*dal pr.e of $ibnb medi2r the twu
rnpetu cid in bbte 2 lor d 3b 7
daF but rhG eo\nique F$i6 €etul "ddjtiod
erzlutjon
m€do|rrbd|yeg'imFdrondyor It shouldbe noEd d\d all non&retire @obic
b@6e b rr@ n6inc retdrveb the nmbe6 or facurdjteeDbicor@j3c
llble z EHnller or hed ia Md itrrubrtion ordribi.|

ltrpbna soyaaga tsorbm

'Iblbe
s}? lcr (soyba

I turrsPd ddsdi,€,.. I Pm"tun..mtsd,d

s.h:ed]g'gJ
PGreJU.edb|oodJsa]jIrUd|nDs]J'ou,ebld6
FTddjos furcbe:g,r ]

o :,r:!!
I ciud
hauer eddoE!*d hdqc @didoN
^&, i^Rrcft tuir bE
 r\tuLz.1996 \

I
6 V.lidation of bioburden tectuiq@s
jneuldion.Af.el,\€inocu]mis5nowedbd4tr
,ppepri& fof d'e pioduct, lne me6od eletrd ror
nedodoloe/ 'llrifr&tr shodd rad b a iNjlh! inb cdous dctH4ais ftom d'e @nicdd produd
&e micrcflon e6hs on I plodud ri dd6lo mrc E ud&:cd A dio or ihe rccoveftd dh b inid
tuue bioburden6rdio6 rc[abrq EN 7+l pdicur,r nethod ad Dmduc!
nquiE in{ ax bchniqus 6ed @ !"lid:bd ed dr
Mmbir Lrdl]dion h6 riniaicB suchs
wi'joi in d e Levetof rhe meutm md de5e

'nn€Iga'istu eom nedicrr dsic6 thse mi o.d'cer micl€4mnN ftis prccedue m

t re!4riw reh{! of a sarile prcdrr; ribdre a ean &6budon or d&€rgaisus D
'
b) podud inoai.don eirl' tdom tcvlls oi
.fl'cli':toil]leapp6&hshAihe,d/eh!sol

.ona 6rion Ldqu6, de\cb tuariud Epliation d ddetealnc Emov€dtun rnc

95im ior 6ing purpe. Tlie s

ffiqu6uoNsioib4lliobililyb$emiEa]
dMdor Howe4 dris 4p6&h a be nsedro.
The pmcipre udstvmc u zplro:rn E dEr il€
L\encno'€ntr@tmfie#hlrlerlmdjd
nmbq or mi.@Igajs ltoreEd ard ach
repe'tion,ir'eelumtis.oblyRoveltdnomthe
prcduct or pFduct Fodon ad 4mded ReLdb
rcmula@d fton rhe collserive l1oven6 c
compred rr shoutdbc nore4 hqevq rld ,\s
nerhod is nor eceswtu rKise rhe ed
* TrrjoENp l,a$een r]l€ nmb€r of mcr€tfums
Need {d lne &ir:] nmbnm lne oodnd
Y)'.-.mol
alwaF be ddoEn*ed
6.2.3P|oductinocultlknne|hod
ine ii:d onb produd ad re&in tne eruentior n
biobunlenArifrdton medrodshodd thei be udliz.d h
oder tor Fsible innibitingor pDmotug erd b bc
PhFier lors nay be u*d b rcmove
tu@rcdiffi frDn dreF.duci (se 6.2.4) rhe
(appbtubly 100colonr .ofrins ui6) sho,jd be
4d b lne Dhsical forc6 b be M
EnmEdon ol dre 'ni@4a'iFs gjv6 a m.:ff
of the eERc or rhe prFicd forc
efiec oi d'e eluenron the siv?r
rcmovdfumpfunuctshor'db!b]cninb

boq imbeE or s ec6d mi@'sruro o h

e nof comon ap@!.n dJia @hic brcdd a) he mi@{qdsm iovotved

sroG Tne 6e or resedjve mc@4:lrlft
d ncdt h !d.e
be:6e ol de tN ot uj,!d
a hrh eeque,(v (ffi
on deR
r'e ni.@4ajstu N€n ror dds sljdjron sdv mv
rg sg|eckd mi.IH4fujsro my ihddd;
bJ mspNlic regednr mjclH.seBro (slm
posh€ mdor slm nesatiw):
c) spo.6 of s'oefomine sEn Dcidw batena
E
b) ae nmbq or conhimiinc nicnts|srisro
er"€.bd (dd rqui€ oFiddjoc
sucx 6 the
ned b conccne or dnu6 fte erdeno;
c) rhe pNibirj9 of cing nebnorc &rii6r ro
6J,2 The qalidiryd d€ bioburdd 6{in& rdcery
d die 3ni[o' d uc shded me b sppor
b) d. diny of d'e eteden hnpedu

/
 EN 11742 : 1996

TteobJ:ed€o|@insoutitcnddEisisb
sek Biderce dd a pcs duge h6 ;cre4
snen &e bioburdcn 6dl1re @ bei4 6ed b {enhougldedimer,n{in\in*!|ishedlhjc
Ti.m]]Fss.meddtbyeleiJxnc$cdufo.3
plrr']a'nj5im@futL\4IIc'@6lim*is
obdcd ltroieover in rcurjnety onbning rhe
me tutud pdcipt6 or sddcar Drcc6 conrop).
ror e:npre d,ecusu,'d{)5)6)7)Gmelire sm)
mehdoraM]Fis'qbe4p[od

\ha.agenei']loo{|cdgeo.d[biobudenis
innrrcs \r,on apopdnc *miijig;uine
'Ihe very ofrft nticrobiorosi.aldab or d a sari{rcbry
biobdan 6ntu g.rded duin* dd
dd'ion'rc'id.abg|ineio!NsingctEA6l

mdEentch,ng6o.fdrderem'hhg!\cefrdo.
s€ if !\n f.qu.n.y rB ch,nSedu
Tnesddqgoip4scontallinib
dese'rni€met'rodsro|JekdimddE6n
Duing dr initi, muurtu ot a new prcdud o. on
'lhechoiceofunib'orbiobudmesri@bbc
Ed n plocs nonibring is b3ed on hitunet sfuJoBda.e|div€lyl[ghd€qtr*ryinorderto
dare
T'e de +odd b€ an4\d b sR ir they ir : 8.in conf'den.ein dre co6l of uheproe. once .
rwer of coddhe h6 bu dnncd dr ft@ew
Posrn. brod uider dre rudrca oi d @ be leducedso L\d rcuEnesweilae ot fie'
ple6isaNmdTneftquen.yshoddb€elEed
(e4 by brhg losaidm, nob or h ode. b dekr d@u6 in biobudcn ovd unq fd
FRes) rd fided .
b r Hosntad madpmii.:n &dbrtion rsrn
@p6&esasfu'connden.!|rnibabouia
tu& H be.rcubbd goqevq r iDppopnde
m|om,donbaregnnedma,'em]n4j]

dr'
h'c6beffinetheh&nc]@ndfudhe
reverbelow wrlch 91 96oi L\e coub r,l (or 90 %
or 9€ 96vhicheu G ch6.n). Tne oedodic r*iee of
adopEd rriri6, wbch is reqded by EN r?1-1, 6 be

/
e|&*${lcMG.dou,vdndvd3Dqe94,ld
 t2
: 1996

a
Amex A (info@tive) DewhE! E 11Ra{e4 D,Mdd sblq Gc (r$6) Tde
@olamodel*embsnp@lne€nicisryo|
ultleudada€dminrneEoveryofa?.ill6
I s&tts @e frlm po\ms surfacs I -42r
EN2$Ja q'alita a@tuatu mt &ilil!
c6rko, M.t (t93a)The Ne or Tm
EN4sa0r cmt qith:a Jt ue oPntba ol medim tor enme6drg lw levelsor bdaia ton
iMhbre ndriurs P,raD ?1r,m, 3 Gl), 5€n0.
EN4ilJr Qnlit4 swtu - Madi,t daia H:Is, N A ,, d {rt$) rte o{tr:lnmce ol atylic.ny
Padicuttr fltuimb J6 tu hcn prdedn non midbi:r oub (sik6) on
apdxaLb 4 EN2eaoI hy?odmic EoducG iadt"rPr,ls c,m 22 (3),
EN4$az QLditu$s@t-Mdtul 8
Padicutar wiw6 Jn ut Pdrm,tR, Flv@, M.s ed Pe@Ga\t Os67)usc or
ardi@.rta o! EN2e@2 rn@r'jc cnergyh sstrrc nicobial conhii4oi
d t @alit! on surr,c6 ,aal,'It r{tt, rt (6),l3{+5r
tlsosw]i aualiqmmsaM
' '{. Mon (1990)Tcdmiel R@d Bioburdenr€.ovev
Pafl3 ctutd.tiB !6 L\r Lpdi.aLiaa ol r^d^jo^ r Paffit s.L lbdmt 44 (6J,374.et.
Isae@l10 e dadanaq sut?q1dnn Hobon, r rd NFtom, B C935)BacEdalcomb on

Hds6on, H.o md ZiegletiN.R.(1933)Appldjon or
5bli9i6bpobleGinba.bnolo6llAmeso.
dehmda brei,r popnltioE by l]le dnudon
mL\od 1 rk biol s5, 10u21.
obweq r.L ad robuaea Jl| (r95) UndeEhdras
ad@.!rin'ghedpmb:slenmb{teclmisd
J MiLhF@d,Itxhrcl 34, E40445
slDrle, r"N. ad ra1l6d, aK (le?t) seffiei a
new con epi in b2&nobgiczr smpb pa@dion
(e.I, a (re7a A frelhod ror sNins fte led or
micobi,r onbnidion !n slisical tutuis. L44t
Gbrbe4: B.O (r9@ Mi@siologicarsrrudon or
su@ itu bdo€ Edlrion stuilidior ,4rpl
renc,D( Lin, LL ad H@, Lv (1S90)Inpotuc€ of
ul@ni€don condido6 ln @ftry ol midbial
conhidion tum tudal sde t .{"r{ Ad.@rtrl

BoDlslc J.R Osso)a modelsscn ror te$ry nw

ruaii,js.orniobia]conhnLPlamft'ftno,
 EN llzl-2 : t99i

Amex zA (infomstiv.)
addressins
ess€ntiar
requirenenrs
o' other
;i;"l?S S'"BH:.til,:y"darir
T n s E @ @ t u d : r d h a b e " rp F r,c.\clc.o,,l"c,uoPd
ff113"#"3f;.H"#lF.: Jrzd'
"*
rtr rd irtu"*
::#sfi""Hffi*-**,.Leb6epduc(s)firLingh&intha
l,l".'h:T'#E""FffSr,,A"*-* inbbre
alr rc rikerv
'iosppodqun'*n6 o,&e

:trrHi::f,$?xh":ff""ffiT."stsrAiT$.yJ*-"*
t-)
C9

g
€s

./