1、DD CEN ISO/TS17665-2:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWDRAFT FOR DEVELOPMENTSterilization of healthcare products MoistheatPart 2: Guidance on the application ofISO 17665-1 (ISO 17665-2:2009)Copyright European Committee for Standardization Provided
2、 by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This Draft for Developmentwas published under theauthority of the StandardsPolicy and StrategyCommittee on 28 February2009 BSI 2009ISBN 978 0 580 55837 5Amendments/corrigenda issued since
3、 publicationDate CommentsDD CEN ISO/TS 17665-2:2009National forewordThis Draft for Development is the UK implementation of CEN ISO/TS17665-2:2009.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications andis of a provisional
4、 nature. It should be applied on this provisional basis,so that information and experience of its practical application can beobtained.Comments arising from the use of this Draft for Development arerequested so that UK experience can be reported to the internationalorganization responsible for its c
5、onversion to an international standard.A review of this publication will be initiated not later than 3 years afterits publication by the international organization so that a decision can betaken on its status. Notification of the start of the review period will bemade in an announcement in the appro
6、priate issue of Update Standards.According to the replies received by the end of the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sent to
7、the Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be
8、obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Copyright European Committee for Standardizati
9、on Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-TECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONCEN ISO/TS 17665-2January 2009ICS 11.080.01English VersionSterilization of health care products - Moist hea
10、t - Part 2:Guidance on the application of ISO 17665-1 (ISO 17665-2:2009)Strilisation des produits de sant - Chaleur humide -Partie 2: Directives relatives lapplication de lISO 17665-1 (ISO 17665-2:2009)Sterilisation von Produkten fr die Gesundheitsfrsorge -Feuchte Hitze - Teil 2: Leitfaden fr die An
11、wendung vonISO 17665-1 (ISO 17665-2:2009)This Technical Specification (CEN/TS) was approved by CEN on 23 November 2008 for provisional application.The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit theircomments,
12、particularly on the question whether the CEN/TS can be converted into a European Standard.CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS availablepromptly at national level in an appropriate form. It is permissible to keep confli
13、cting national standards in force (in parallel to the CEN/TS)until the final decision about the possible conversion of the CEN/TS into an EN is reached.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Gree
14、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Ce
15、ntre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN ISO/TS 17665-2:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction
16、or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009CEN ISO/TS 17665-2:2009 (E) 3 Foreword This document (CEN ISO/TS 17665-2:2009) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ of the International Organization for Standardizat
17、ion (ISO) and has been taken over as CEN/TS ISO 17665-2:2009 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or
18、CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Cyprus, Czech Republ
19、ic, 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 the United Kingdom. Endorsement notice The text of ISO 17665-2:2009 has b
20、een approved by CEN as a CEN/TS ISO 17665-2:2009 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009ISO/TS 17665-2:2009(E) ISO 20
21、09 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Quality management system elements 2 5 Sterilizing agent characterization . 2 5.1 Sterilizing agent 2 5.2 Microbicidal effectiveness . 2 5.3 Material effects 3 5.4 E
22、nvironmental considerations 3 6 Process and equipment characterization 3 6.1 Process 3 6.2 Equipment . 6 7 Product definition . 7 8 Process definition. 8 9 Validation. 10 9.1 General. 10 9.2 Installation qualification (IQ) . 11 9.3 Operational qualification (OQ). 11 9.4 Performance qualification (PQ
23、) . 13 9.5 Review and approval of the validation . 14 10 Routine monitoring and control 15 11 Product release from sterilization. 16 12 Maintaining process effectiveness . 17 12.1 Demonstration of continued effectiveness 17 12.2 Recalibration . 17 12.3 Maintenance of equipment 17 12.4 Requalificatio
24、n 17 12.5 Assessment of change. 18 Annex A (informative) Evaluation of a sterilization process primarily based on the measurement of physical parameters. 19 Annex B (informative) Evaluation of a sterilization process primarily based on biological inactivation and an accompanying mechanical air remov
25、al procedure . 27 Annex C (informative) Temperature and pressure of saturated steam for use in moist heat sterilization 30 Annex D (informative) Special considerations for health care settings . 32 Annex E (informative) Index of normative clauses/subclauses of ISO 17665-1 and cited references or rel
26、ated guidance given in ISO 17665-1 and ISO/TS 17665-2 41 Bibliography . 44 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009ISO/TS 17665-2:2009(E) iv ISO
27、 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation 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 i
28、n 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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commis
29、sion (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 technical committees is to prepare International Standards. Draft International Standards adopted by the technical
30、 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. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may d
31、ecide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Tech
32、nical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirme
33、d for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possi
34、bility 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/TS 17665-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 17665 consists of the foll
35、owing parts, under the general title Sterilization of health care products Moist heat: Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Part 2: Guidance on the application of ISO 17665-1 Technical Specification Copyright European
36、 Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved vIntroduction The guidance given in this Technical Specification is no
37、t intended as a checklist for assessing compliance with ISO 17665-1. This guidance is intended to assist in obtaining a uniform understanding and implementation of ISO 17665-1 by providing explanations and acceptable methods for achieving compliance with specified requirements. It highlights importa
38、nt aspects and provides examples. Methods other than those given in this guidance may be used. However, the use of alternative methods has to be demonstrated to be effective in achieving compliance with ISO 17665-1. The main body of this document is applicable to all settings where moist heat steril
39、ization is carried out. The annexes to this guidance document also specify detailed means of implementing the requirements of ISO 17665-1 and represent current best practices. The numbering of the clauses in the main body of this Technical Specification corresponds to that in ISO 17665-1. Medical de
40、vices reprocessed in health care facilities include a wide variety of product with varying levels of bioburden. Appropriate and thorough cleaning and, where necessary for safe handling, decontamination processes are essential prior to presenting product for sterilization. Mixed product loads are com
41、mon in healthcare facilities with throughput volumes dictated by historical and predicted demand for sterile product. Health care facilities do not normally specify sterilization processes for any individual medical device. Also, it is impractical for health care facilities to determine bioburden on
42、 a medical device. It is important that specified instruments be disassembled before decontamination and thoroughly inspected after completion of the sterilization process. Reassembly and assessment of functionality are also needed. Therefore, the medical device manufacturers instructions (see ISO 1
43、766423) should be followed for all aspects of cleaning, disinfection, packaging and sterilization. Many devices can be fully immersed and can be washed and disinfected in automated equipment (see ISO 1588319-22). For devices that cannot be fully immersed and that cannot tolerate thermal decontaminat
44、ion, alternative methods of disinfection should be used to ensure safe handling. Such procedures and policies should be in place to ensure that medical devices undergo appropriate reprocessing. Particular attention needs to be paid to the drying and storage of sterile medical devices. Requirements f
45、or packaging of medical devices are covered in ISO 11607-18and ISO 11607-29. If multiple sterilization cycles can lead to degradation and limit the useful life of a medical device, the manufacturer will specify the number of reprocessing cycles that can normally be tolerated. When selecting a medica
46、l device, priority should be given to properties such as ease of cleaning and disassembly. Additional guidance specific to health care is offered in Annex D of this Technical Specification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reprod
47、uction or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-DD CEN ISO/TS 17665-2:2009TECHNICAL SPECIFIC
48、ATION ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved 1Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 1 Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization
49、 processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to
