1、October 2011 Translation by DIN-Sprachendienst.English price group 18No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 11.080.20!$u;“1822488www.din.deDDIN EN ISO 14160Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devicesutilizing animal tissues and their derivatives Requirements for characterization, development, validation and routinecontrol of a sterilization pro
3、cess for medical devices (ISO 14160:2011)English translation of DIN EN ISO 14160:2011-10Sterilisation von Produkten fr die Gesundheitsfrsorge Flssige chemische Sterilisiermittel fr Medizinprodukte fr den einmaligen Gebrauch, beidenen tierische Gewebe und deren Derivate verwendet werden Anforderungen
4、 an die Charakterisierung, Entwicklung, Validierung und Lenkung derAnwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 14160:2011)Englische bersetzung von DIN EN ISO 14160:2011-10Strilisation des produits de sant Agents strilisants chimiques liquides pour dispositifs mdicaux non rutilis
5、ables utilisantdes tissus animaux et leurs drivs Exigences pour la caractrisation, le dveloppement, la validation et le contrle de routinedun procd de strilisation de dispositifs mdicaux (ISO 14160:2011)Traduction anglaise de DIN EN ISO 14160:2011-10SupersedesDIN EN ISO 14160:1998-06www.beuth.deDocu
6、ment comprises pagesIn case of doubt, the German-language original shall be considered authoritative.4410.11 DIN EN ISO 14160:2011-10 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” (
7、Secretariat: ANSI, United States), in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 0
8、63-01-07 AA Sterilisation von Medizinprodukten. The DIN Standards corresponding to the International Standards referred to in this standard are as follows: ISO 9004 DIN EN ISO 9004 ISO 10012 DIN EN ISO 10012 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-17 DIN EN ISO 10993-17 ISO 11135-1 DIN EN ISO 11135
9、-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11138-1 DIN EN ISO 11138-1 ISO 11737-1 DIN EN ISO 11737-1 ISO 11737-2 DIN EN ISO 11737-2 ISO 13485 DIN EN ISO 13485 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 17665-1 DIN EN ISO 17665-1 ISO 22442 (all parts) DIN EN ISO 22442 (all parts) Amendments
10、 This standard differs from DIN EN ISO 14160:1998-06 as follows: a) the requirements for quality management system elements have been revised; b) requirements for the characterization of the sterilizing agent, of the process and equipment and requirements for the product and process definition have
11、been included/supplemented; c) requirements for validation have been revised and subdivided into installation qualification, operational qualification, performance qualification, review and approval of validation; d) requirements for physical performance qualification (PPQ) have been included; e) re
12、quirements for review and approval of validation and for routine monitoring and control have been revised/included; f) requirements for product release have been revised and the parametric release has been added; g) requirements for maintaining process effectiveness have been supplemented; h) Annex
13、B (normative) “Determination of lethal rate of the sterilization process” has been supplemented; i) the standard has been editorially revised. DIN EN ISO 14160:2011-10 3 Previous editions DIN EN ISO 14160: 1998-06 National Annex NA (informative) Bibliography DIN EN ISO 9004, anag DIN EN ISO 10012, M
14、easurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing DIN EN ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leacha
15、ble substances DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for
16、 development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination
17、of a population of microorganisms on products DIN EN ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process DIN EN ISO 13485, Medical devices Quality management systems Requir
18、ements for regulatory purposes DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and rou
19、tine control of a sterilization process for medical devices DIN EN ISO 22442-1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management DIN EN ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, colle
20、ction and handling DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy M ing for the sustained success of an organization A quality management approach DIN
21、EN ISO 14160:2011-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14160 July 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 utilizi
22、ng animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) Strilisation des produits de sant - Agents strilisants chimiques liquides pour dispositifs mdicaux non rutilisables
23、 utilisant des tissus animaux et leurs drivs - Exigences pour la caractrisation, le dveloppement, la validation et le contrle de routine dun procd de strilisation de dispositifs mdicaux (ISO 14160:2011) Sterilisation von Produkten fr die Gesundheitsfrsorge - Flssige chemische Sterilisiermittel fr Me
24、dizinprodukte fr den einmaligen Gebrauch, bei denen tierische Gewebe und deren Derivate verwendet werden - Anforderungen an die Charakterisierung, Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 14160:2011) This European Standard was approved
25、 by CEN on 30 June 2011. 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 stand
26、ards may be obtained on application to the CEN-CENELEC 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 no
27、tified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithua
28、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CE
29、N All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14160:2011: EDIN EN ISO 14160:2011-10 EN ISO 14160:2011 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 6 2 Normative references 7 3 Terms and definitions .7 4 Quality managem
30、ent system elements .10 4.1 Documentation.10 4.2 Management responsibility 11 4.3 Product realization.11 4.4 Measurement, analysis and improvement Control of non-conforming products 11 5 Sterilizing agent characterization 11 5.1 General11 5.2 Sterilizing agent .11 5.3 Microbicidal effectiveness 12 5
31、.4 Effects on materials.12 5.5 Safety and the environment12 6 Process and equipment characterization .12 6.1 General12 6.2 Process characterization 13 6.3 Equipment characterization13 7 Product definition 13 8 Process definition14 8.1 Purpose.14 8.2 Determination of the inactivation kinetics 14 8.3
32、Method for neutralization15 8.4 Safety quality and performance .15 9 Validation15 9.1 General15 9.2 Installation qualification16 9.3 Operational qualification.16 9.4 Performance qualification.16 9.5 Review and approval of validation.18 10 Routine monitoring and control.19 11 Product release from ste
33、rilization21 12 Maintaining process effectiveness 21 12.1 General21 12.2 Maintenance of equipment .21 12.3 Requalification .21 12.4 Assessment of change22 Annex A (informative) Guidance for the application of this International Standard 23 Annex B (normative) Determination of lethal rate of the ster
34、ilization process 34 Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2).38 Bibliography 39 Annex ZA (informative) Relationship between this European Standard and the Essential Requirem
35、ents of EU Directive 93/42 EEC on Medical Devices .40 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 which
36、 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 possib
37、ility 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 Europe
38、an 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 organization
39、s 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,
40、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. “ DIN EN ISO 14160:2011-10 EN ISO 14160:2011 (E) 3 Introduction A sterile medical device is one that
41、 is free of viable 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 sterili
42、zation be minimized. 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 sterilizatio
43、n is to inactivate 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 exp
44、onential relationship 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 pro
45、bability of survival 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
46、sterility of a processed 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
47、subsequent storage, 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,
48、for certain processes 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 sterilizat
49、ion process is monitored 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 materials 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
