1、BRITISH STANDARD BS EN 556-1:2001 Incorporating Corrigendum No. 1 Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devices The European Standard EN 556-1:2001 has the status of a British Standard ICS 1
2、1.080.01 BS EN 556-1:2001 This British Standard, having been prepared under the direction of the Health and Environmental Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 11 December 2001 BSI 2006 ISBN 0 580 38311 3 National fo
3、reword This British Standard was published by BSI. It is the UK implementation of EN 556-1:2001, including Corrigendum September 2006. It supersedes BS EN 556:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/67, Sterilization of medical devices
4、. A list of organizations represented on CH/67 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal
5、 obligations. Amendments issued since publication Amd. No. Date Comments 16728 Corrigendum No. 1 31 October 2006 Correction to the note in 4.1 and correction to reference 7 to EN 1441EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 556-1 October 2001 ICS 11.080.01 Supersedes EN 556:1994 English
6、version Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devices Strilisation des dispositifs mdicaux Exigences relatives aux dispositifs mdicaux en vue dobtenir ltiquetage STERILE Partie 1: Exigences
7、relatives aux dispositifs mdicaux striliss 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 European Standard was approved by CEN on 1
8、8 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 b
9、e 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 Manageme
10、nt 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. EUR
11、OPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 Incorporatin
12、g Corrigendum September 2006EN 556-1:2001 (E) 2 Contents Page Foreword 3 Introduction 4 1 Scope 4 2 Normative references 4 3 Terms and definitions 4 4 Requirements 6 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 7 Bibl
13、iography 8EN 556-1:2001 (E) 3 Foreword This European Standard has been prepared by Technical Committee CEN/TC 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
14、 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 Fr
15、ee 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 CEN/TC 204 as one of a sequence of European Standards concerned with sterili
16、zation processes and their control. The other standards in this series are: EN 550, Sterilization of medical devices Validation and routine control of ethylene oxide sterilization. EN 552, Sterilization of medical devices Validation and routine control of sterilization by irradiation. EN 554, Steril
17、ization of medical devices Validation and routine control of moist heat sterilization. prEN 556-2, Sterilization of medical devices Requirements for medical devices to be designated “Sterile” Part 2: Requirements for aseptically processed medical devices (in preparation). EN 1174, Sterilization of m
18、edical devices Estimation of the population of micro-organisms on product. EN ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998). EN ISO 14937, Sterilization of
19、 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). Annexes designated informative are given only for information. In this standard annex ZA is info
20、rmative. 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, No
21、rway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.EN 556-1:2001 (E) 4 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 microbiol
22、ogical contamination of a medical device from all sources is minimized by all practical means. Even so, product items produced under 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
23、 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 m
24、icro-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 treat
25、ment, 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 any one item subjected to sterilization processing cannot be guaranteed and the sterility of the proc
26、essed items has to be defined in terms of the probability of the existence of a surviving micro-organism on/in 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 i
27、s 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
28、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
29、 storage and to the control of the environment in which the product is manufactured, assembled and packaged. 1 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 fo
30、r 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 validat
31、ion 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. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative referen
32、ces 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 la
33、test 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 Part
34、icular requirements for the application of EN/ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996). 3 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
35、 standard.EN 556-1:2001 (E) 5 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
36、 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 p
37、hysiological 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
38、.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 thereofE
39、N 556-1:2001 (E) 6 4 Requirements 4.1 For a terminally-sterilized medical device to be designated “STERILE”, the theoretical probability of there being a viable micro-organism present on/in the device shall be equal to or less than 1 10 -6 . NOTE Permission for acceptance of a probability greater th
40、an that specified in 4.1 may be sought through the appropriate regulatory bodies. Such permission depends on the individual situation, including consideration of the risk management activites (see, for example, EN ISO 14971) undertaken by the manufacturer of the medical device. 4.2 Compliance shall
41、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 IS
42、O 13488:2000, 4.5 and 4.16. NOTE 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 dem
43、onstrates 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) 7 Ann
44、ex 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 require
45、ments of EU Directive 93/42/EEC. 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, 93/42/EE
46、C and 98/79/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/sub-clauses of this Eu
47、ropean Standard Essential requirements (ER:s) of Directive 93/42/EEC, Annex I Essential requirements (ER:s) of Directive 90/385/EEC, Annex I Essential requirements (ER:s) of Directive 98/79/EC, Annex I 4.1 1, 8.1, 13.3 (c) 1, 7, 14.1 7 thdash 1, 2.1, 8.4 (c) 4.2 8.4 2.4EN 556-1:2001 (E) 8 Bibliograp
48、hy 1 EN ISO 9001:1994, Quality systems Model for quality assurance in design/development, production, installation and servicing (ISO 9001:1994). 2 EN ISO 9002:1994, Quality systems Model for quality assurance in production, installation and servicing (ISO 9002:1994). 3 EN 550, Sterilization of medi
49、cal devices Validation and routine control of ethylene oxide sterilization. 4 EN 552, Sterilization of medical devices Validation and routine control of sterilization by irradiation. 5 EN 554, Sterilization of medical devices Validation and routine control sterilization by moist heat. 6 EN 980, Graphical symbols for use in the labelling of medical devices. 7 EN ISO 14971:2000, Medical devices Application o
