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1、DD CEN ISO/TS 17665-2:2009 ICS 11.080.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW DRAFT FOR DEVELOPMENT Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 (ISO 17665-2:2009) Licensed CopyChinese University of Hong Kong, 1
2、1/04/2009 09:01, Uncontrolled Copy, (c) BSI This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 28 February 2009 BSI 2009 ISBN 978 0 580 55837 5 Amendments/corrigenda issued since publication DateComments DD CEN ISO/TS 17665-2:2009 National
3、foreword This Draft for Development is the UK implementation of CEN ISO/TS 17665-2:2009. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis
4、, so that information and experience of its practical application can be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for its conversion to an international standard. A review o
5、f this publication will be initiated not later than 3 years after its publication by the international organization so that a decision can be taken on its status. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to
6、 the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Tech
7、nical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on this committee can be obtained on request to its secretary.
8、 This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled
9、Copy, (c) BSI TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 17665-2 January 2009 ICS 11.080.01 English Version Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO 17665-2:2009) Strilisation des produits de
10、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 von ISO 17665-1 (ISO 17665-2:2009) This Technical Specification (CEN/TS) was approved by
11、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 their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CE
12、N 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 available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision abou
13、t 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
14、 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 2009 CENAll rights of exploitation in any f
15、orm and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 17665-2:2009: E Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled Copy, (c) BSI DD CEN ISO/TS 17665-2:2009 CEN ISO/TS 17665-2:2009 (E) 3 Foreword This document (CEN ISO/TS 17665-2:2009) h
16、as 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 CEN/TS ISO 17665-2:2009 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is h
17、eld 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 CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards
18、organizations of the following countries are bound 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, Po
19、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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. Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled Copy, (
20、c) BSI DD CEN ISO/TS 17665-2:2009 ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved iii Contents 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
21、5.2 Microbicidal effectiveness. 2 5.3 Material effects 3 5.4 Environmental 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 Operati
22、onal qualification (OQ). 11 9.4 Performance qualification (PQ). 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 Recalibratio
23、n . 17 12.3 Maintenance of equipment 17 12.4 Requalification 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 biolo
24、gical inactivation and an accompanying mechanical air removal 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 clau
25、ses/subclauses of ISO 17665-1 and cited references or related guidance given in ISO 17665-1 and ISO/TS 17665-2 41 Bibliography. 44 Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled Copy, (c) BSI DD CEN ISO/TS 17665-2:2009 ISO/TS 17665-2:2009(E) iv ISO 2009 All rights reser
26、ved Foreword 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 in a subject for which
27、 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 Commission (IEC) on all mat
28、ters 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 committees are circu
29、lated 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 decide to publish othe
30、r 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 Technical Specification (
31、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 confirmed for a further three
32、 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 possibility that some of t
33、he 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 following parts, under th
34、e 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 Licensed CopyChinese University of Hong
35、 Kong, 11/04/2009 09:01, Uncontrolled Copy, (c) BSI DD CEN ISO/TS 17665-2:2009 ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved v Introduction 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
36、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 important aspects and provides examples. Methods other than those given in this guidance may be used. How
37、ever, 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 sterilization is carried out. The annexes to this guidance document also specify detailed means of imple
38、menting 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 devices reprocessed in health care facilities include a wide variety of product with varying levels
39、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 common in healthcare facilities with throughput volumes dictated by historical and predicted demand f
40、or 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 a medical device. It is important that specified instruments be disassembled before decontaminati
41、on 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 1766423) should be followed for all aspects of cleaning, disinfection, packaging and sterilization.
42、 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 decontamination, alternative methods of disinfection should be used to ensure safe handling. Such procedures a
43、nd 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 for packaging of medical devices are covered in ISO 11607-18 and ISO 11607-29. If multiple steriliz
44、ation 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 medical device, priority should be given to properties such as ease of cleaning and disassembly. Additi
45、onal guidance specific to health care is offered in Annex D of this Technical Specification. Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled Copy, (c) BSI DD CEN ISO/TS 17665-2:2009 Licensed CopyChinese University of Hong Kong, 11/04/2009 09:01, Uncontrolled Copy, (c) BS
46、I DD CEN ISO/TS 17665-2:2009 TECHNICAL SPECIFICATION ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved 1 Sterilization 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
47、 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 practice related to moist heat sterilization processes and to assist those developing and va
48、lidating 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, so that the guidance given under a particular clause or subclause of this part of ISO 17665 a
49、pplies 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 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 document. For dated references,