1、BRITISH STANDARD - _ BS EN Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization The European Standard EN 550 : 1994 has the status of a British Standard UDC 615.478.73 550: 1994 Copyright European Committee for Standardization Provided by IHS under licens
2、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 660 : 1994 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
3、on 15 October 1994 O BSI 1994 The following BI references relate to the work on this standard: Committee reference HCC/67 Draft for comment 91/57776 DC: ISBN O 580 23201 8 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was p
4、repared, comprises the national standards organizations of the following countries: Austria Belgium Denmark Finland France Germany Greece Iceland Ireland Italy Luxembourg Net herlands Norway Portugal Spain Sweden Switzerland United Kingdom Oesterreichisches Normungsinstitut Institut belge de normali
5、sation Dansk Standard Suomen Standardisoimisliito, r. y. Association franaise de normalisation Deutsches Institut fr Normung e.V. Hellenic Organization for Standardization Technological Institute of Iceland National Standards Authority of Ireland Ente Nazionale Italiano di Unificazione Inspection du
6、 Travail et des Mines Nederlands Normalisatie-instituut Norges Standardiseringsforbund Instituto Portugus da Qualidade Asociacin Espaola de Normalizacin y Certificacin Standardiseringskommissionen i Sverige Association suisse de normalisation British Standards Institution Amendments issued since pub
7、lication Amd. No. Date kxt affected Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CEN EN*550 94 = 3404589 0073bL2 355 BS EN 550 : 1994 Contents Cooperating organizations Inside
8、 front cover National foreword i Foreword 2 %xt of EN 550 3 National annex NA (informative) Committees responsible inside back cover National annex NB (informative) Cross-references Inside back cover National foreword This British Standard has been prepared under the direction of the Health Care Sta
9、ndards Policy Committee and is the English language version of EN 550 : i994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization, published by the European Committee for Standardization (CEN) . EN 550 was produced as a result of international discussions
10、 in which the United Kingdon took an active part. Compliance with a British Standard does not of itself confer immunity from legal obligations. i Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without licen
11、se from IHS-,-,-NORME EUROPENNE EUROPISCHE NORM June 1994 UDC: 615.478.73 Descriptors: Medical equipment, sterilization, ethylene oxide, definitions, qualification, inspection, specifications English version Sterilization of medical devices - Validation and routine control of ethylene oxide steriliz
12、ation Strilisation de dispositifs mdicaux - Validation et contrle de routine pour la strilisation loxyde dthylne Sterilisation von Medizinprodukten - Validierung und Routineberwachung fr die Sterilisation mit Ethylenoxid This European Standard was approved by CEN on 1994-06-27. CEN members are bound
13、 to comply with the CENCENELEC 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 Cent
14、ral Secretariat or to any CEN member. The 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 Central Secretariat has the same status as t
15、he 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 Kingdom. CEN European Committee for Standardization Comit Euro
16、pen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1OM) Brussels O 1994 Copyright reserved to CEN members Ref. No. EN 550 : 1994 E Previous page is blank Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleN
17、o reproduction or networking permitted without license from IHS-,-,-CEN EN*550 94 = 3404589 0073634 328 = Page 2 EN 550 : 1994 Foreword This European Standard has been prepared by the Technical Committee CENiTC 204 Sterilization of Medical Devices, the secretariat of which is held by BSI. This Europ
18、ean Standard has been prepared under a Mandate given to CEN by the European Communities and the European Free Trade Association, and supports essential requirements of EC Directive( s) . This standard has been considered by CENrTC 204 as one of a sequence of European standards concerned with three c
19、ommon sterilization processes and their control. These standards are: EN 550 EN 552 EN 554 EN 556 Sterilization of medical deuices - Validation and routine control of ethylene oxide sterilization Sterilization of medica dev.ices - Validation and routine control of sterilization by irmdiatwn Steriliz
20、ation of medical Mes - Validation and routine control of sterilization by moist heat Sterilization of medical devices - Requirements for medical deuices to be labelled STERLLE In this European Standard the terms defined in clauses 3 are in italic type. This European Standard shall be given the statu
21、s of a national standard, either by publication of an identical text or by endorsement, at the latest by December 1994, and conflicting national standards shall be withdrawn at the latest by December 1994. According to the CENXENELEC Internal Regulations, the following countries are bound to impleme
22、nt this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents Foreword Introduction 1 Scope 2 Normative references 3 Definitions 4 General 5 Validation 6
23、 Process control and monitoring 7 Product release from sterilization Annexes A (normative) Method for calculating D-values using microbiological performance qualification method B B (informative) Guidance on the application of EN 550 C (informative) Bibliography b3e 2 3 4 4 6 7 8 8 11 11 23 Copyrigh
24、t European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CEN EN*550 94 = 3404589 0073635 Ob4 M Introduction A sterile product item is one which is free of viable micro-organisms. The European Sta
25、ndards 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 all practical means. Even so, product items produced under standard manufacturing conditions in accordance w
26、ith the requirements for 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
27、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 dezuices often approximates to an exponential relationship; inevitably this means that there is always a finite probability th
28、at a micro-organism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and types of micro-organisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one it
29、em in a population 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 value taken by this probability is specified else
30、where (see EN 556). However, the principles specified in this standard are applicable irrespective of the stated probability. Requirements for the quality system for the designdevelopment , production, installation and servicing of medical devices are given in EN 46001 and EN 46002 which supplement
31、the EN 29000 series of European Standards. Page 3 EN 550 : 1994 The EN 29000 series of standards designates certain processes used in manufacture as special if the results cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of a special process b
32、ecause 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 process monitored routinely and the equipment maintained. It is important to be aware that exposure to a properly vali
33、dated and accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is stmile and, in this respect, suitable for its intended use. Attention has also to be given to a number of factors including the microbiological status
34、(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. The object of this European Standard is standardization in the field of validation and routine monitoring of ethylene
35、oxide sterilization processes and procedures that are carried out by those who sterilize medical devices. The validation of sterilization procedures presupposes that the sterilization equipment complies with appropriate specifications. This standard contains requirements for the validation and routi
36、ne monitoring of sterilization by gaseous ethylene oxide; guidance on the application of this standard is offered in informative annex B. NOTE. The requirements are the obligatory parts of this standard in that these are to be observed if compliance is to be achieved. The guidance given in annex B i
37、s not obligatory and it is not provided as a check list for auditors. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- CEN ENS550 94 - 3404589 0073bLb TTO = page 4 EN 560 : 1994
38、1 Scope 1.1 This European Standard specifies requirements for the development, validation, process control and monitoring of the sterilization of medical devices using ethylene oxide. NOTE. Specifications for sterilizers are being prepared by CENm 102. 1.2 This European Standard does not describe a
39、quality assurance system for the control of all stages of manufacture. NOTE. Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete qua
40、lity system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text. 1.3 This European Standard does not cover operator safety (see note). NOTE. Ethylene oxide is toxic, flammable and explosive. Attention is drawn t
41、o the existence in some countries of national regulations laying down safety requirements for handiing ethylene oxide and for premises in which it is used. 1.4 This European Standard does not cover the level of residual ethylene oxide within medical devices. NOTE. Attention is drawn to the existence
42、 in some countries of standards stipulating the level of ethylene oxide residue within mecEicaz cfmices. 2 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 th
43、e 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 a
44、pplies. EN 556) Sterilhtion of medical dezuices - Requirements for medical devices to be labelled STERLI.8 Biological systems for testing steril* rt 2. Systems for use in ethylene oxide st mil Wces -. Estimatwn of ULe population of micro-organisms on product Part 1 . Requirements EN 866-2) EN 1174-1
45、1) Sterilization of medical EN 29001 : 1987 EN 29002 : 1987 EN 46001 : 1993 EN 46002 : 1993 3 Definitions Quality systems - Model for quality assurance in designlckvelqnmnt, production, installation and semvicing Quality systems - Model for quality assurance in production and installation particular
46、 requirements for th application of EN 29001 for medical devices particular requirements for the application of EN 29002 for medical devices For the purposes of this standard, the following definitions apply. 3.1 aeration Part of the sterilization process during which ethylene oxide and/or its react
47、ion products desorb from the medical We until predetermined levels are reached. NOTE. This may be performed within the sterilizer and/or in a separate chamber or roinn. 3.2 bioburden Population of viable micro-organisms on a product and/or a package. 3.3 biological indicator Inoculated carrier conta
48、ined within its primary pack. 3.4 chamber Enclosed area which only accommodates sufficient product to fill the sterilizer. 3.5 commissionhg Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications and that it functions within predetermin
49、ed limits when operated in accordance with operational instructions. 3.6 conditioning Treatment of product within the sterilization cycle, but prior to sterilant admission, to attain a predetermined temperature and relative humidity throughout the sterilization load. NOTE. This part of the stwiZ.izattvn cgck may be camed out either at atmospheric pressure or under vacuum. (See also preconditioning. ) 3.7 cycle completion That time after
