1、BS EN ISO 14160:2011Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (IS
2、O 14160:2011)BS EN ISO 14160:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO14160:2011. It supersedes BS EN ISO 14160:1998 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical de
3、vices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 57851 9ICS 11.080.01Compliance with
4、a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14160 Ju
5、ly 2011 ICS 11.080.01 Supersedes EN ISO 14160:1998English Version Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control
6、of a sterilization process for medical devices (ISO 14160:2011) Strilisation des produits de sant - Agents strilisants chimiques liquides pour dispositifs mdicaux non rutilisables utilisant des tissus animaux et leurs drivs - Exigences pour la caractrisation, le dveloppement, la validation et le con
7、trle de routine dun procd de strilisation de dispositifs mdicaux (ISO 14160:2011) Sterilisation von Produkten fr die Gesundheitsfrsorge - Flssige chemische Sterilisiermittel fr Medizinprodukte fr den einmaligen Gebrauch, bei denen tierische Gewebe und deren Derivate verwendet werden - Anforderungen
8、an die Charakterisierung, Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 14160:2011) This European Standard was approved by CEN on 30 June 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the co
9、nditions 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exi
10、sts 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national st
11、andards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland an
12、d United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14
13、160:2011: EBS EN ISO 14160:2011EN ISO 14160:2011 (E) 3 Foreword This document (EN ISO 14160:2011) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of whi
14、ch 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 January 2012, and conflicting national standards shall be withdrawn at the latest by January 2012. Attention is drawn to the poss
15、ibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14160:1998. This document has been prepared under a mandate given to CEN by the Euro
16、pean Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizati
17、ons of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal
18、 Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14160:2011 has been approved by CEN as a EN ISO 14160:2011 without any modification. BS EN ISO 14160:2011EN ISO 14160:2011 (E) 4 Annex ZA (informative) Relationship between this Europ
19、ean Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Ap
20、proach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confe
21、rs, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this european
22、Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8,9,10,11,12 8.4WARNING Other requirements and other EU Directives may be applicable to the
23、 product(s) falling within the scope of this Standard. BS EN ISO 14160:2011ISO 14160:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references2 3 Terms and definitions .2 4 Quality management system elements.5 4.1 Documentation 5 4.2 Management
24、responsibility 6 4.3 Product realization 6 4.4 Measurement, analysis and improvement Control of non-conforming products6 5 Sterilizing agent characterization 6 5.1 General .6 5.2 Sterilizing agent.6 5.3 Microbicidal effectiveness7 5.4 Effects on materials 7 5.5 Safety and the environment .7 6 Proces
25、s and equipment characterization .7 6.1 General .7 6.2 Process characterization8 6.3 Equipment characterization .8 7 Product definition8 8 Process definition .9 8.1 Purpose 9 8.2 Determination of the inactivation kinetics9 8.3 Method for neutralization10 8.4 Safety quality and performance.10 9 Valid
26、ation10 9.1 General .10 9.2 Installation qualification .11 9.3 Operational qualification 11 9.4 Performance qualification 11 9.5 Review and approval of validation 13 10 Routine monitoring and control.14 11 Product release from sterilization .16 12 Maintaining process effectiveness16 12.1 General .16
27、 12.2 Maintenance of equipment .16 12.3 Requalification.16 12.4 Assessment of change .17 Annex A (informative) Guidance for the application of this International Standard18 Annex B (normative) Determination of lethal rate of the sterilization process 29 Annex C (informative) Flowchart for microbicid
28、al effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2).33 Bibliography34 BS EN ISO 14160:2011ISO 14160:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation
29、of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. I
30、nternational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with
31、 the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approva
32、l by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14160 was prepared by Technical Committee
33、 ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 14160:1998), which has been technically revised. BS EN ISO 14160:2011ISO 14160:2011(E) ISO 2011 All rights reserved vIntroduction A sterile medical device is one that is free of viable
34、 microorganisms. International standards, which specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimize
35、d. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. The purpose of sterilization is to inactivate
36、 the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relations
37、hip between the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of surviv
38、al is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one medical device in a population of items subjected to sterilization processing cannot be guaranteed and the sterility of a pro
39、cessed population is defined in terms of the probability of there being a viable microorganism present on a medical device. Attention also has to be given to a number of factors, including the microbiological status (bioburden) of incoming raw materials and/or components and their subsequent storage
40、 and to the control of the environment in which the product is manufactured, assembled and packaged (see also ISO 13485). Requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain proces
41、ses used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process is mon
42、itored routinely and the equipment is maintained. Animal tissues and their derivatives are used as constituents of certain medical devices to provide performance characteristics that present advantages over the characteristics provided by non-animal-based materials. The range and quantities of mater
43、ials of animal origin in medical devices vary; such materials can comprise a major part of the device, can be a product coating or impregnation, or can be used in the manufacturing process for the medical device. This International Standard describes requirements that, if met, will provide a liquid
44、chemical sterilization process that has appropriate microbicidal activity for single-use medical devices containing materials of animal origin or their derivatives. The sterilizing agents used most frequently for medical devices are moist heat, dry heat, irradiation and ethylene oxide. While some de
45、vices containing animal tissues may be compatible with these commonly applied methods of sterilization (historically, for example, catgut sutures have been sterilized by irradiation), other devices, such as biological heart valves or tissue patches, are not compatible with conventional sterilization
46、 processes. It has been recognized that other sterilizing agents might have to be used in these exceptional circumstances. Liquid chemical sterilization is normally chosen over other sterilization processes in order that the medical devices present the desired physical properties of the tissue after
47、 sterilization. Sterilization by liquid chemicals of medical devices made in whole or in part from tissues of animal origin represents a special case in terms of establishing an effective sterilization process. In common with the other sterilization methods, the efficacy of a liquid chemical sterili
48、zation process needs to be demonstrated and recorded before it is adopted for routine use. Liquid chemical sterilization requires determination of types of microorganisms comprising the bioburden and their resistance to the sterilization process in order to establish the appropriate reference microo
49、rganism, whether that be a recognized biological indicator or an isolate from the bioburden. Compliance with the requirements of this International Standard ensures that the microbicidal activity of the liquid chemical BS EN ISO 14160:2011ISO 14160:2011(E) vi ISO 2011 All rights reservedsterilization process is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on a product after sterilization. Specification of
