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)This Draft for Developmentwas published under theauthorit
2、y of the StandardsPolicy and StrategyCommittee on 28 February2009 BSI 2009ISBN 978 0 580 55837 5Amendments/corrigenda issued since 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
3、to be regarded as a British Standard.It is being issued in the Draft for Development series of publications andis of a provisional 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 th
4、is Draft for Development arerequested so that UK experience can be reported to the internationalorganization responsible for its conversion to an international standard.A review of this publication will be initiated not later than 3 years afterits publication by the international organization so tha
5、t a decision can betaken on its status. Notification of the start of the review period will bemade in an announcement in the appropriate 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 theconvers
6、ion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sent tothe Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entr
7、usted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct applicat
8、ion.Compliance with a British Standard cannot confer immunityfrom legal obligations.TECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONCEN ISO/TS 17665-2January 2009ICS 11.080.01English VersionSterilization of health care products - Moist heat - Part 2:Guidance on the application o
9、f 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 Anwendung vonISO 17665-1 (ISO 17665-2:2009
10、)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, particularly on the question whether the
11、 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 conflicting national standards in force (in pa
12、rallel 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, Greece, Hungary, Iceland, Ireland, Italy, La
13、tvia, 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 Centre: Avenue Marnix 17, B-1000 Brussels
14、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: EDD 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
15、“Sterilization of health care products“ of the International Organization for Standardization (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 t
16、hat 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound
17、to announce this Technical Specification: Austria, Belgium, Bulgaria, 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,
18、 Switzerland and the United Kingdom. Endorsement notice The text of ISO 17665-2:2009 has been approved by CEN as a CEN/TS ISO 17665-2:2009 without any modification. DD CEN ISO/TS 17665-2:2009ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2
19、 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 Environmental considerations 3 6 Process and equipment characterization 3 6.1 Pro
20、cess 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) . 13 9.5 Review and approval of the validation . 14 10 Routine monitoring and
21、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 Requalification 17 12.5 Assessment of change. 18 Annex A (informative) Evaluation of a sterili
22、zation 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 removal procedure . 27 Annex C (informative) Temperature and pressure of saturated st
23、eam 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 related guidance given in ISO 17665-1 and ISO/TS 17665-2 41 Bibliography . 44 DD CE
24、N ISO/TS 17665-2:2009ISO/TS 17665-2:2009(E) iv ISO 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 t
25、echnical 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 liaison with ISO, also take part in the work. ISO collaborates clos
26、ely 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 technical committees is to prepare International Standards. Draf
27、t 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. In other circumstances, particularly when there is an urgent market requireme
28、nt for such documents, a technical committee may decide 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 o
29、f the parent committee casting a vote; an ISO Technical 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 ye
30、ars in order to decide whether it will be confirmed 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 Standar
31、d or be withdrawn. 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/TS 17665-2 was prepared by Technical Committee ISO/TC 198, Sterilization of he
32、alth care products. ISO 17665 consists of the following 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
33、17665-1 Technical Specification 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 not intended as a checklist for assessing compliance with ISO 17665-1. This guidance is intended to assist in obtaining a
34、uniform understanding and implementation of ISO 17665-1 by providing explanations and acceptable methods for achieving compliance with specified requirements. It highlights important aspects and provides examples. Methods other than those given in this guidance may be used. However, the use of alter
35、native 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 sterilization is carried out. The annexes to this guidance document also specify detailed means of implementing the requiremen
36、ts 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 devices reprocessed in health care facilities include a wide variety of product with varying levels of bioburden. Appropri
37、ate and thorough cleaning and, where necessary for safe handling, decontamination processes are essential prior to presenting product for sterilization. Mixed product loads are common in healthcare facilities with throughput volumes dictated by historical and predicted demand for sterile product. He
38、alth 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 a medical device. It is important that specified instruments be disassembled before decontamination and thoroughly insp
39、ected after completion of the sterilization process. Reassembly and assessment of functionality are also needed. Therefore, the medical device manufacturers instructions (see ISO 1766423) should be followed for all aspects of cleaning, disinfection, packaging and sterilization. Many devices can be f
40、ully 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 decontamination, alternative methods of disinfection should be used to ensure safe handling. Such procedures and policies should be
41、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 for packaging of medical devices are covered in ISO 11607-18and ISO 11607-29. If multiple sterilization cycles can lead t
42、o 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 medical device, priority should be given to properties such as ease of cleaning and disassembly. Additional guidance specific
43、to health care is offered in Annex D of this Technical Specification. DD CEN ISO/TS 17665-2:2009DD CEN ISO/TS 17665-2:2009TECHNICAL SPECIFICATION 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
44、 Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization 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
45、practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, s
46、o that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to
47、the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D. 2 Normative references The following referenced documents are indispensable for the application of this docu
48、ment. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine co
49、ntrol of a sterilization process for medical devices NOTE The normative references in ISO 17665-1 refer to published standards, the content of which should be used to assist in demonstrating compliance to the clause in which they are cited. Some are required mainly for moist heat sterilization in industry or for manufacturers of moist heat sterilizers and could go beyond typical practice for those performing sterilization in health care facilities. ISO 17665-1 specifies a number of methods and procedures that can be used to monito
