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I.S. EN 556-1 (2002) (English): Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices [Authority: The European Union Per Directive 90/385/EEC]

National Standards Authority of Ireland

IRISH STANDARD

I.s. EN 556-1 :2002

res

11 .080.01

STERILISATION OF MEDICAL DEVICES REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY
STERILISED MEDICAL DEVICES
National Standards Authority of Ireland Dub lin 9 Ireland Tel (01) 807 3800 Tel ' (01) 807 3838

ThIS Irtsh Standard was publIshed under the authority of the National Standards Authority of Ireland and comes mto effect on January 18 2002

NO COPYING WITHOUT NSAI PERMISSION EXCEPT AS PERMITIED BY COPYRIGHT LAW

NSAI 2002
Udaras urn Chaighdeain Naisiunta na hEireann

Price Code

EUROPEAN STANDARD
NORME EUROPEENNE EUROpAISCHE NORM
les 11.080.01

EN 556-1 :2001 lAC

September 2006 Septembre 2006 September 2006

English version Version Frangaise Deutsche Fassung

Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices Sterilisation des dispositifs medicaux Exigences relatives aux dispositifs medicaux en vue d'obtenir I'etiquetage STERILE - Partie 1: Exigences relatives aux dispositifs medicaux sterilises au stade terminal Sterilisation von Medizinprodukten Anforderungen an Medizinprodukte, die als 'STERIL' gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden

This corrigendum becomes effective on 20 September 2006 for incorporation in the three official language versions of the EN. Ce corrigendum prendra effet Ie 20 septembre 2006 pour incorporation dans les trois versions linguistiques officielles de la EN. Die Berichtigung tritt am 20.September 2006 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft.

EUROPEAN COMMITTEE FOR ST ANDARDIZA TION COMITE EUROP EE N DE NORMALISA n ON EUROpAISCHES KOMITEE FUR NORMUNG

Management Centre: rue de Stassart, 36

B1050 Brussels

2006 CEN

All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Tous droits d'exploitation sous quelque forme et de quelque maniere que ce soit reserves dans Ie monde en tier aux membres nationaux du CEN . Aile Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren , sind weltweit den nationalen Mitgliedern von CEN vorbehalten. Ref. NO.: EN 556-1 :2001/AC:2006 D/E/F

EN 556-1 :2001/AC:2006 (E/D)

English version
Note to 4.1 Delete the second sentence (beginning 'Such permission requires .. .') and replace it by "Such permission depends on the individual situation, including consideration of the risk management activities (see, for example, EN ISO 14971) undertaken by the manufacturer of the medical device." Bibliography Delete reference 7 to EN 1441 and replace it with EN ISO 14971 :2000 Medical devices - Application of risk management to medical devices (ISO 14971:2000)

Deutsche Fassung
Anmerkung zu 4.1
Der zweite Satz (beginnend mit "Eine derartige Genehmigung ... ") ist zu streichen und durch den folgenden Satz zu ersetzen: "Eine derartige Genehmigung hangt von der individuellen Situation ab, einschlier1lich der Berucksichtigung der vom Hersteller des Medizinproduktes durchgefuhrten Aktivitaten zum Risikomanagement (siehe z. B. EN ISO 14971)."

Literaturhinweise
Der Literaturhinweis 7 auf EN 1441 ist zu streichen und durch eine Referenz auf EN ISO 14971 :2000, Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2000) zu ersetzen.

EUROPEAN STANDARD

EN 556-1

NORME EUROPEENNE EUROpAISCHE NORM

ICS 11.080.01

October 2001
Supersedes EN 556:1994

English version

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Sterilisation des dispositifs medicaux - Exigences relatives aux dispositifs mooicaux en vue d'obtenir I'etiquetage STERILE - Partie 1: Exigences relatives aux dispositifs mecticaux sterilises au stade terminal Sterilisation von Medizinproduk1en - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden

This European Standard was approved by CEN on 1B August 2001. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITIEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG

Management Centre: rue de Stassart, 36

B-1050 Brussels

2001 CEN

All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

Ref. No. EN 556-1:2001 E

EN 5561.:2001 (E)

Contents
Foreword ......................................................................................................................................................................3 Introduction .................................................................................................................................................................4

1 Scope ......................................................................................................................................................................4

2 Normative references ............................................................................................................................................4

3

Terms and definitions ...........................................................................................................................................4 Requirements .........................................................................................................................................................6

Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives .........................................................................................................................7 Bibliography ................................................................................................................................................................ B

EN 556-1 :2001 (E)

Foreword
This European Standard has been prepared by Technical Committee CENrrC 204, Sterilization of medical devices, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2002, and conflicting national standards shall be withdrawn at the latest by April 2002. This European Standard supersedes EN 556: 1994. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. This standard has been considered by CENfTC 204 as one of a sequence of European Standards concerned with sterilization processes and their control. The other standards in this series are:
EN 550 EN 552

Sterilization of medical devices -Validation and routine control of ethylene oxide sterilization. Sterilization of medical devices -Validation and routine control of sterilization by irradiation Sterilization of medical devices -Validation and routine control of moist heat sterilization Sterilization of medical devices - Requirements for medical devices to be deSignated "Sterile"Part 2: Requirements for aseptically processed medical devices (in preparation) Sterilization of medical devices - Estimation of the population of micro-organisms on product Sterilization of single-use medical devices incorporating materials of animal Origin - Validation and routine control of sterilization by liquid chemical sleri/ants (ISO 14160: 1998) Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (/SO 14937:2000)

EN 554 prEN 556-2

EN 1174 EN ISO 14160

EN ISO 14937

Annexes deSignated 'informative' are given only for information. In this standard annex ZA is informative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic. Denmark, Finland, France, Germany. Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

EN 556-1 :2001 (E)

Introduction
A sterile product item is one, which is free of viable micro-organisms. European Standards for medical devices
require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources is minimized by a/l practical means. Even so, product items produced undfr standard manufacturing conditions in accordance with their requirements for quality systems for medical devices (see EN ISO 13485:2000 or EN ISO 13488:2000) may, prior to sterilization, have micro-organisms on them. albeit in low numbers. Such product items are non-sterile. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones. The inactivation of a pure culture of micro-organisms by physical and/or chemical agents used to sterilize medical devices often approximates to an exponential relationship; inevitably this means that, regardless of the extent of treatment applied, there is always a finite probability that a micro-organism will survive. For a given treatment, the probability of survival is determined by the number and resistance of micro-organisms and by the environment in which the organisms exist during treatment It follows that the sterility of anyone item subjected to sterillzation processing cannot be guaranteed and the sterility of the processed items has to be defined in terms of the probability of the existence of a surviving micro-organism onlin an item. The standards for quality management systems recognize that there are processes used which cannot be fully verified by subsequent inspection and testing of product. Sterilization is an example of such a process. Sterilization processes have to be validated before use. the performance of the process monitored routinely and the equipment maintained. It is important to be aware that exposure to a properly validated and accurately controlled sterilization process is not the only factor associated with the provision of assurance that the product item is sterile and. in this respect, suitable for its intended use. Attention has also to be given to a number of factors including the microbiological status (bioburden) of incoming raw materials and/or components, their subsequent storage and to the control of the environment in which the product is manufactured, assembled and packaged.

Scope

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILe'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography). deSignation of a medical device as 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for valIdation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552. EN 554, EN ISO 14160 and EN ISO 14937.

Normative references

This European Standard incorporates by dated or undated reference, prOVisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN ISO 13485:2000, Quality systems - Medical devices - Particular requirements for the application of EN/ISO 9001
(revision of EN 46001:1996) (identical to ISO 13485:1996)

EN ISO 13488:2000, Quality systems - Medical devices - Particular requirements for the application of EN/ISO 9002
(revision of EN 46002:1996) (identical to ISO 13488:1996)

Terms and definitions

For the purposes of this standard. the following terms and definitions apply.
NOTE Terms defined in this clause are set in Italic type throughout the text of this standard.

EN 556-1 :2001 (E)

3.1
bioburden

population of viable micro-organisms on a product and/or package

3.2
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application. intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

3.3
sterility

state of being free from viable micro-organisms

3.4
sterile

condition of a medical device that is free from viable micro-organisms

3.5
terminally-sterilized
condition of a medical device which has been exposed to a sterilization process in a packaged or assembled form that maintains the sterility of the medical device or a defined portion thereof

EN 556-1 :2001 (E)

4
4.1

Requirements

For a terminally-sterilized medical device to be designated "STERILE", the theoretical probability of there 6 being a viable micro-organism present on/in the device shall be equal to or less than 1x10
NOTE Permission for acceptance of a probability greater than that specified in 4.1 may be sought through the appropriate regulatory bodies. Such permission requires consideration of the individual situation, including consideration of the risk analYSIS (see, for example, EN 1441) undertaken by the manufacturer of the medical device.

4.2

Compliance shall be shown by the manufacturer or supplier through provision of documentation and records which demonstrate that the devices have been subjected to a validated sterilization process fulfilling 4.1.

The documentation and records shall be retained as specified in EN ISO 13485:2000, 4.5 and 4.16 or EN ISO 13488:2000,4.5 and 4.16.
I'JOTE 1 Evidence that a medical device is sterile comes from: i} the initial validation of the sterilization process and subsequent revalidations that demonstrate the acceptability of the process; and ii) information gathered during routine control and monitoring which demonstrates that the validated process has been delivered in practice. NOTE 2 The achievement of sterility is predicted from the bioburden level on products, the resistance of the micro-organisms comprising that bioburden and the extent of treatment imposed during sterilization.

EN 556-1 :2001 (E)

Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or other provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive 93/421EEC. WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. The following clauses of this standard, as detailed in table ZA.1, are likely to support requirements of Directives 90/385/EEC, 93/421EEC and 98f79/EC. Compliance with the clauses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulations.

Table ZA.1 - Correspondence between this European Standard and EU Directives

Clauses/su bclauses of this European Standard Essential requirements (ER:s) of Di rective 93/42/EEC, Annex I 1, 8.1, 13.3 (c) 8.4 Essential requirements (ER:s) of Directive 90/385/EEC, Annex I 1, 7, 14.1 7 dash
m

Essential requirements (ER:s) of Directive 98/79/EC Annex I 1,2.1,8.4 (c) 2.4

4.1 4.2

EN 5561 :2001 (E)

Bibliography

[1 J EN ISO 9001:1994

Quality systems - Model for quality assurance in design/development, production, installation and servicing (ISO 9001 :1994) Quality systems - Model for quality assurance in production, installation and servicing (ISO 9002:1994) Sterilization of medical devices sterilization Validation and routine control of ethylene oxide

[2]

EN ISO 9002:1994

[3J

EN 550

[4]

EN 552

Sterilization of medical devices Validation and routine control of sterilization by irradiation Sterilization of medical devices - Validation and routine control sterilization by moist heat Graphical symbols for use in the labelling of medical devices Medical devices - Risk analysis Sterilization of single-use medical devices incorporating materials of animal ongln Validation and rolJtine control of sterilization by liquid chemical sterilants (ISO 14160:1998) Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
14 Council Directive of (O.J.L 169 pp 1.43 (12 July 1993)

[5J
[6]

EN 554

EN 980 EN 1441 EN ISO 14160:1998

[7]
[8]

[9]

EN ISO 14937:2000

[10) 90/385/EEC

[11] 93/42JEEC

June

1993

concerning

medical

devicHs

[12J 98n9/EC

Council Directive of 27 October 1998 on in vitro diagnostic medical devices