1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devicesBS EN ISO 17664:2017National forewordThis British Standard is the UK implementation
2、 of EN ISO 17664:2017. It is identical to ISO 17664:2017. It supersedes BS EN ISO 17664:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this commi
3、ttee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 82544 6ICS 11.080.
4、01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 17664
5、:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 17664December 2017ICS 11.080.01 Supersedes EN ISO 17664:2004EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No.
6、EN ISO 17664:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersProcessing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)Traitement de produits de so
7、ins de sant - Informations relatives au traitement des dispositifs mdicaux fournir par le fabricant du dispositif (ISO 17664:2017)Aufbereitung von Produkten fr die Gesundheitsfrsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen fr die Aufbereitung von Medizinprodukten (ISO 17664:2
8、017)This European Standard was approved by CEN on 3 August 2017.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 re
9、ferences concerning such national standards 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 C
10、EN 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 standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedoni
11、a, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 17664:2017 (E)European forewordThis document (EN
12、 ISO 17664:2017) 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 is held by BSI.This European Standard shall be given the status of a national
13、standard, either by publication of an identical text or by endorsement, at the latest by June 2018, and conflicting national standards shall be withdrawn at the latest by June 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. C
14、EN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 17664:2004.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 Directi
15、ve(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (including any amendments) liste
16、d below applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowle
17、dged state-of-art.When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard as listed below.NOTE The way in which these referenc
18、ed documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.Table Correlation between normative references and dated EN and ISO standardsNormative references as listed in Clause 2 of the ISO standardEquivalent dated standardEN ISOISO 14971 EN ISO
19、14971:2012 ISO 14971:2007According 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, Former Yugoslav Republic
20、of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 17664:2017 has been a
21、pproved by CEN as EN ISO 17664:2017 without any modification.2BS EN ISO 17664:2017EN ISO 17664:2017 (E)Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devicesThis European Standard has been prepared under a Commis
22、sions standardization request M/023 concerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169.Once this document is cited in the
23、 Official Journal of the European Union under that Directive, compliance with the normative 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 associate
24、d EFTA regulations.NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest
25、possible level, minimized or removed, according to the wording of the corresponding essential requirement.NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.NOTE 3 This Annex ZA is based on
26、 normative references according to the table of references in the European foreword, replacing the references in the core text.NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.Table ZA.1 Correspondence between this Europe
27、an Standard and Directive 93/42/EECEssential Requirements (ERs) of Directive 93/42/EECClause(s)/sub-clause(s) of this EN Remarks/Notes13.6h first and second paragraphs only4,5,6,7 13.6i 4,5,6,7 ER 13.6 i) is covered only for the sterilization of devices supplied non-sterile as a further treatment pr
28、ior to use.WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of th
29、e European Union.WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard.3BS EN ISO 17664:2017ISO 17664:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Validation of the processes identified in the
30、information provided by the medical device manufacturer 55 Risk analysis 56 Information to be provided by the medical device manufacturer 66.1 General . 66.2 Processing instructions . 66.3 Limitations and restrictions on processing 66.4 Initial treatment at the point of use 76.5 Preparation before c
31、leaning 76.6 Cleaning . 76.6.1 General 76.6.2 Automated cleaning 76.6.3 Manual cleaning 86.7 Disinfection 96.7.1 General 96.7.2 Automated disinfection 96.7.3 Manual disinfection . 96.8 Drying 106.9 Inspection and maintenance 106.10 Packaging 106.11 Sterilization . 116.12 Storage 116.13 Transportatio
32、n . 117 Presentation of the information .12Annex A (informative) Commonly utilized processing methods 13Annex B (informative) Example of processing instructions for reusable medical devices.18Annex C (informative) Classification of medical devices 20Annex D (informative) Additional guidance on infor
33、mation to be provided by the medical device manufacturer .23Bibliography .24iv ISO 2017 All rights reservedContents PageBS EN ISO 17664:2017ISO 17664:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). Th
34、e work of preparing 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-gov
35、ernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described i
36、n the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the p
37、ossibility 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO lis
38、t of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related
39、 to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 198, Sterilization of health
40、care products.This second edition cancels and replaces the first edition (ISO 17664:2004), which has been technically revised. The scope has been increased to include medical devices requiring disinfection and/or sterilization prior to use. ISO 2017 All rights reserved vBS EN ISO 17664:2017ISO 17664
41、:2017(E)IntroductionThis document applies to manufacturers of those medical devices that are intended to be processed by the user or a third party to be made ready for use. This includes medical devices that are intended for reuse and require processing to take them from their state after clinical u
42、se to the state of being cleaned, disinfected and/or sterilized and ready for their next use, and single-use medical devices that are supplied non-sterile but are intended to be used in a clean, disinfected and/or sterile state and therefore will require processing prior to use.Significant advances
43、in technology and knowledge have resulted in the development of complex medical devices to support the delivery of healthcare to patients. These advances have led to medical devices being designed that are potentially more difficult to clean, disinfect and/or sterilize.Cleaning, disinfecting and ste
44、rilizing technologies have also undergone significant change in the past decade, resulting in new systems and approaches that can be applied in the processing of medical devices. This has led to a greater appreciation of the need for validation of processing including cleaning, disinfection and/or s
45、terilization in order to ensure that medical devices are effectively processed. These developments have led to the need to ensure that manufacturers of reusable medical devices provide adequate instructions that support the end users to undertake safe and effective processing of medical devices, uti
46、lizing the available equipment and processes.A medical device requiring processing is supplied with detailed processing instructions in order to ensure that, when followed correctly, the risks of transmission of infectious agents are minimized. In addition, effective processing minimizes the risk of
47、 other adverse effects on medical devices.Cleaning is an important step in rendering a used medical device safe for reuse. Failure to remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from both the inside and outside surfaces of medical devices could compromis
48、e any subsequent disinfection and/or sterilization process or the correct functioning of the medical device. Single-use medical devices provided by the medical device manufacturer for processing prior to use can also require cleaning prior to further processing.After cleaning, other factors can affe
49、ct the safe and effective use of a medical device. For example, procedures for inspection and functional testing might be necessary to ensure that a medical device does not pose a safety risk when used. Manufacturers of medical devices can assist users by providing instructions on how this inspection and testing should be performed.Manufacturers of medical devices that are to be processed have a responsibility to ensure that the design of the medical devices facilitates achievement of effective processing. This includes consideration of commonly ava
