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1、BRITISH STANDARD BS EN 556:1995 Sterilization of medical devices Requirements for terminally-sterilized devices to be labelled “Sterile” The European Standard EN 556:1994 has the status of a British Standard Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled
2、 Copy, (c) BSI BS EN 556:1995 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 March 1995 BSI 12-1998 The following BSI references relate to the work on
3、this standard: Committee reference HCC/67 Draft for comment 91/57782 DC ISBN 0 580 23204 2 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of the following countrie
4、s: AustriaOesterreichisches Normungsinstitut BelgiumInstitut belge de normalisation DenmarkDansk Standard FinlandSuomen Standardisoimisliito, r.y. FranceAssociation franaise de normalisation GermanyDeutsches Institut fr Normung e.V. GreeceHellenic Organization for Standardization IcelandTechnologica
5、l Institute of Iceland IrelandNational Standards Authority of Ireland ItalyEnte Nazionale Italiano di Unificazione LuxembourgInspection du Travail et des Mines NetherlandsNederlands Normalisatie-instituut NorwayNorges Standardiseringsforbund PortugalInstituto Portugus da Qualidade SpainAsociacin Esp
6、aola de Normalizacin y Certificacin SwedenStandardiseringskommissionen i Sverige SwitzerlandAssociation suisse de normalisation United KingdomBritish Standards Institution Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:
7、00 2006, Uncontrolled Copy, (c) BSI BS EN 556:1995 BSI 12-1998i Contents Page Cooperating organizationsInside front cover National forewordii Foreword2 Text of EN 5563 National annex NA (informative) Committees responsibleInside back cover National annex NB (informative) Cross-referencesInside back
8、cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 556:1995 ii BSI 12-1998 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is the English language versi
9、on of EN 556:1994 Sterilization of medical devices Requirements for medical devices to be labelled “Sterile”, published by the European Committee for Standardization (CEN). EN 556 was produced as a result of international discussions in which the United Kingdom took an active part. A British Standar
10、d does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an
11、 inside front cover, pages i and ii, the EN title page, pages 2 to 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffield
12、un sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 556 December 1994 ICS 11.080 Descriptors: Medical equipment, sterilization, sterility, quality assurance, labelling, specifications English version Sterilization of
13、 medical devices Requirements for medical devices to be labelled “Sterile” Strilisation des dispositifs mdicaux Exigences pour les dispositifs mdicaux tiquettes “Strile” Sterilisation von Medizinprodukten Anforderungen an Medizinprodukte, die als “Steril” gekennzeichnet werden This European Standard
14、 was approved by CEN on 1994-12-05. 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 nat
15、ional standards may be obtained on application to the Central Secretariat 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 n
16、otified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kin
17、gdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN members Ref. No. EN 556:1994 E Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00
18、:00 2006, Uncontrolled Copy, (c) BSI EN 556:1994 2 BSI 12-1998 Foreword This European Standard has been prepared by the Technical Committee CEN/TC 204, Sterilization of medical devices, the secretariat of which is held by BSI. This European Standard has been prepared under a mandate given to CEN by
19、the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). 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 June 1995, and conflicting
20、national standards shall be withdrawn at the latest by June 1995. This standard has been considered by CEN/TC 204 as one of a sequence of European Standards concerned with three common sterilization processes and their control. These standards, which are currently in preparation, are: EN 550, Steril
21、ization 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, Sterilization of medical devices Validation and routine control of sterilization by moist heat.
22、EN 556, Sterilization of medical devices Requirements for medical devices to be labelled “Sterile”. Annexes designated “informative” are given only for information. In this standard annex A is informative. In accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to
23、implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents list Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions4 4Requ
24、irements4 Annex A (informative) Bibliography5 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 556:1994 BSI 12-19983 Introduction A sterile product item is one which is free of viable micro-organisms. The European Standards for medical dev
25、ices 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 all practical means. Even so, product items produced under standard manufacturing conditions in accordance with the requirements f
26、or quality systems for medical devices (see EN 46001 or EN 46002) 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
27、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 there is always a finite probability that a micro-organism may
28、 survive regardless of the extent of treatment applied. 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 any one item in a population
29、 of items subjected to sterilization processing cannot be guaranteed and the sterility of the processed population of items has to be defined in terms of the probability of the existence of a non-sterile item in that population. The European Pharmacopoeia Commission considers that a product may be r
30、egarded as sterile when the theoretical level of not more than one living micro-organism is present in 1 106 sterilized units of the final product. The principles of the standards EN 550, EN 552 and EN 554 are applicable irrespective of the stated probability. Requirements for the quality system for
31、 the design/development, production, installation and servicing of medical devices are given in EN 46001 and EN 46002 which supplement the EN 29000 series of European Standards. The EN 29000 series of standards designates certain processes used in manufacture as “special” if the results cannot be fu
32、lly verified by subsequent inspection and testing of the product. Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. For this reason, sterilization processes have to be validated before use, the performance of the pr
33、ocess 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 is sterile and, in this respect, suitable for i
34、ts 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. 1 Scope 1.
35、1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled “STERILE”. NOTEFor the purposes of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device “STERILE” is only permissible wh
36、en a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices. 2 Normative r
37、eferences 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
38、 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. EN 46001:1993, Quality systems Medical devices Particular requirements for the application of EN 29001. EN 4600
39、2:1993, Quality systems Medical devices Particular requirements for the application of EN 29002. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 556:1994 4 BSI 12-1998 3 Definitions For the purposes of this standard, the following definit
40、ions apply. 3.1 bioburden population of viable micro-organisms on a product and/or a package 3.2 medical device (the definition given in EN 46001 applies) 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
41、NOTEBecause of the nature of microbial inactivation kinetics, it is not possible to verify if any one device, selected at random from a sterilized population of devices, conforms to the condition defined in 3.3. It is not practicable, therefore, to apply this definition to the condition of all devic
42、es comprising a sterilized population. 4 Requirements 4.1 For a terminally-sterilized medical device to be labelled “STERILE”, the theoretical probability of there being a viable micro-organism present on the device shall be equal to or less than one in 1 106. NOTEIn certain instances, the use of a
43、probability greater than that specified in this standard may be acceptable to regulatory authorities. Such instances require individual consideration of the compatibility of the medical device with recognized sterilization methods and of evidence of benefit for patient care. It is not possible to en
44、compass these instances within a standard, but mechanisms exist within a regulatory system to permit their acceptance. 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 st
45、erilization process achieving the requirement (4.1). The documentation and records shall be retained as specified in 4.5.1 and 4.16 of EN 46001:1993 or 4.4.1 and 4.15 of EN 46002:1993. NOTE 1The achievement of sterility is predicted from the bioburden level on products, the resistance of the micro-o
46、rganisms comprising that bioburden and the extent of treatment imposed during sterilization. NOTE 2It is necessary to maintain sterility during handling, storage and delivery until use of the sterile device. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled
47、 Copy, (c) BSI EN 556:1994 BSI 12-19985 Annex A (informative) Bibliography EN 29001, Quality systems Model for quality assurance in design/development, production, installation and servicing. EN 29002, Quality systems Model for quality assurance in production and installation. EN 550, Sterilization
48、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, Sterilization of medical devices Validation and routine control of sterilization by moist heat. 90/385/E
49、EC, Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. 93/42/EEC, Council Directive of 14 June 1993 concerning medical devices (O.J.L 169, pp 1-43 (12 July 1993). Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 6 blank Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 556:1995 BSI 12-1998 National annex NA (informa