1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 25424:2011Sterilization of medical devices Low temperature steam andformaldehyde Requirementsfor development, validationand routine control of asterilization process fo
2、r medicaldevices (ISO 25424:2009)BS EN ISO 25424:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO25424:2011. It is identical to ISO 25424:2009. It supersedes BS EN15424:2007 which is withdrawn.The UK participation in its preparation was entrusted to Tech
3、nicalCommittee CH/198, Sterilization of medical devices.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 2011I
4、SBN 978 0 580 72806 8ICS 11.080.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedEUROPEAN STAN
5、DARD NORME EUROPENNE EUROPISCHE NORM EN ISO 25424 June 2011 ICS 11.080.01 Supersedes EN 15424:2007English Version Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (I
6、SO 25424:2009) Strilisation des dispositifs mdicaux - Formaldhyde et vapeur faible temprature - Exigences pour le dveloppement, la validation et le contrle de routine dun procd de strilisation pour dispositifs mdicaux (ISO 25424:2009) Sterilisation von Medizinprodukten - Niedertemperatur-Dampf- Form
7、aldehyd - Anforderungen an die Entwicklung, Validierung und Routineberwachung von Sterilisationsverfahren fr Medizinprodukte (ISO 25424:2009) This European Standard was approved by CEN on 3 June 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condi
8、tions 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 exists
9、 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 stand
10、ards 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 and U
11、nited 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 25424
12、:2011: EBS EN ISO 25424:2011EN ISO 25424:2011 (E) 3 Foreword The text of ISO 25424:2009 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 25424:2011 by Technical Co
13、mmittee 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 text or by endorsement, at the latest by December 2011, and conflicting national standards sha
14、ll be withdrawn at the latest by December 2011. Attention is drawn to the possibility 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 15424:2007
15、. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts of this document
16、. According to the CEN/CENELEC Internal Regulations, the national standards organizations 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, Irela
17、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 25424:2009 has been approved by CEN as a EN ISO 25424:2011 without any modification. BS EN ISO 25
18、424:2011EN ISO 25424:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the
19、European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a nati
20、onal standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, 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
21、.1 Correspondence between this European Standard and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement is only partly addressed in this European Standard WARNING Other requi
22、rements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 25424:2011EN ISO 25424:2011 (E) 5 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices Th
23、is European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Jo
24、urnal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding
25、 Essential Requirements of that Directive and associated EFTA regulations. Table ZB.1 Correspondence between this European Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 8.3 This relevant Essential
26、 Requirement is only partly addressed in this European Standard 4,5,6,7,8,9,10,11,12 8.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 25424:2011EN ISO 25424:2011 (E) 6 Annex ZC (informative) Relationship b
27、etween this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic 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 a means of conforming to Es
28、sential Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic 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 clauses
29、 of this standard given in Table ZC.1 confers, 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 ZC.1 Correspondence between this European Standard and Directive 98/79/EC
30、 Clauses of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 B.2.3 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8,9,10,11,12 B.2.4 WARNING Other requirements and other EU Directives may be appli
31、cable to the product(s) falling within the scope of this Standard. BS EN ISO 25424:2011ISO 25424:2009(E) ISO 2009 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing
32、 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. International organizations, governmental and non-governmental, in liais
33、on 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 the rules given in the ISO/IEC Directives, Part 2. The main task of te
34、chnical 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 approval by at least 75 % of the member bodies casting a vote. Attention is dr
35、awn 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 25424 was prepared by CEN (as EN 15424:2007) and is submitted for approval under a special “fast-track procedure
36、”, by Technical Committee ISO/TC 198, Sterilization of health care products, in parallel with its approval by the ISO member bodies. For the purposes of this International Standard, the CEN annex regarding the fulfilment of European Council Directives has been removed. BS EN ISO 25424:2011ISO 25424:
37、2009(E) iv ISO 2009 All rights reservedContents Page Foreword vi Introduction vii 1 Scope 1 1.1 Inclusions .1 1.2 Exclusions 1 2 Normative references 2 3 Terms and definitions .2 4 Quality management system elements .8 4.1 Documentation.8 4.2 Management responsibility 8 4.3 Product realization.9 4.4
38、 Control of non-conforming product.9 5 Sterilizing agent characterization 9 5.1 General9 5.2 Sterilizing agent .9 5.3 Microbicidal effectiveness 9 5.4 Material effects.9 5.5 Environmental considerations .10 6 Process and equipment characterization .10 6.1 General10 6.2 Process .10 6.3 Equipment 11 7
39、 Product definition 11 8 Process definition12 9 Validation13 9.1 General13 9.2 Installation qualification13 9.3 Operational qualification.14 9.4 Performance qualification.15 9.5 Review and approval of validation.16 10 Routine monitoring and control.17 10.1 General17 10.2 Biological indicators .17 10
40、.3 Chemical indicators.18 10.4 Records.18 11 Product release from sterilization18 12 Maintaining process effectiveness 18 12.1 General18 12.2 Maintenance of equipment .18 12.3 Requalification .19 12.4 Assessment of change19 Annex A (normative) Process definition based on inactivation of reference mi
41、croorganisms and knowledge of bioburden on product items to be sterilized 20 Annex B (normative) Process definition based on inactivation of reference microorganisms21 BS EN ISO 25424:2011ISO 25424:2009(E) ISO 2009 All rights reserved vAnnex C (informative) Guidance on application of this European S
42、tandard23 Annex D (informative) Environmental aspects regarding development, validation and routine control of Low Temperature Steam and Formaldehyde processes.33 Bibliography37 BS EN ISO 25424:2011ISO 25424:2009(E) vi ISO 2009 All rights reservedForeword This document (EN 15424:2007) has been prepa
43、red 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 text or by endorsement, at the latest by October 2007, and conflicting nat
44、ional standards shall be withdrawn at the latest by October 2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations
45、, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands
46、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN ISO 25424:2011ISO 25424:2009(E) ISO 2009 All rights reserved viiIntroduction A sterile medical device is one which is free of viable microorganisms. European Standards, which specify require
47、ments for validation and routine control of a sterilization process require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturin
48、g conditions in accordance with the requirements for quality management systems (see EN ISO 13485) or which have been subjected to a cleaning process as part of their reprocessing in a health care establishment may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such pro
49、ducts are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products 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 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
