1、BSI Standards PublicationBS EN ISO 22442-2:2015Medical devices utilizing animal tissues and their derivativesPart 2: Controls on sourcing, collection and handlingBS EN ISO 22442-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 22442-2:2015.It supersede
2、s BS EN ISO 22442-2:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee RGM/1, Regenerative medicine.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the
3、 necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 89819 8 ICS 11.100.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British St
4、andard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22442-2 November 2015 ICS 11.100.99 Supersedes EN ISO 22442-2:2007Engli
5、sh Version Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) Dispositifs mdicaux utilisant des tissus animaux et leurs drivs - Partie 2: Contrles de lorigine, de la collecte et du traitement (ISO 22442-2:2015) Ti
6、erische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden -Teil 2: Kontrollen der Beschaffung, Materialgewinnung und Handhabung (ISO 22442-2:2015) This European Standard was approved by CEN on 31 October 2015. CEN members are bound to comply with the CEN/CENELEC I
7、nternal 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 references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
8、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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official
9、 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Nor
10、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of explo
11、itation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22442-2:2015 E2 Contents PageEuropean foreword . 3Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 5EN ISO 22442-2:2015 (E) BS EN ISO 22442-2:20153 Eu
12、ropean foreword This document (EN ISO 22442-2:2015) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 316 “Medical devices utilizing tissues” the secretariat of which is held by DIN. This European Standard
13、shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2016 and conflicting national standards shall be withdrawn at the latest by May 2016. Attention is drawn to the possibility that some of the elements of this document
14、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 ISO 22442-2:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Assoc
15、iation, and supports essential requirements of EU Directive(s). For relationship with EU Directive, 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 latest edit
16、ion of the referenced document (including any amendments) 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 conte
17、nts can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall 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, a
18、s listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table 1 Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO
19、standard Equivalent dated standard EN ISO ISO 22442-1 EN ISO 22442-1:2016 ISO 22442-1:2016 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, Cz
20、ech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, EN ISO 22442-2:2015 (E) BS EN ISO 22442-2:20154 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
21、Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 22442-2:2015 has been approved by CEN as EN ISO 22442-2:2015 without anymodification. EN ISO 22442-2:2015 (E) BS EN ISO 22442-2:2015EN ISO 22442-2:2015 (E) 5 Annex ZA (informative) Relationship between this Europea
22、n Standard and the Essential Requirements of EU Directive 93/42/EEC 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 the Essential Requirements of Directive 93/42/EEC, concerni
23、ng medical devices, as amended by Commission Regulation (EU) No722/2012 in relation to detailed specifications regarding requirements for medical devices utilizing tissues of animal origin. Once this standard is cited in the Official Journal of the European Union under that Directive and has been im
24、plemented as a national standard in at least one Member State, 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 associat
25、ed 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 Directive 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
26、 the lowest 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
27、ZA is based on 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. BS EN ISO 22442-2:2015EN ISO
28、22442-2:2015 (E) 6 Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC asamended by Commission Regulation (EU) No 722/2012 Clause(s)/sub-clause(s) ofthis International Standard Essential Requirements (ERs) ofDirective 93/42/EEC asamended by CommissionRegulation No 722/20
29、12 Qualifying remarks/Notes 4, 5, 6, 7, 8 and Annex A 7.1 Annex B includes suggested formatfor Certificates for animal materials to be used for medical devices. Annex C offers advice on theassessment of veterinary services. 4, 5, 6, 7, 8 and Annex A 7.2 Annex B includes suggested formatfor Certifica
30、tes for animal materials to be used for medical devices. Annex C offers advice on theassessment of veterinary services. 4, 5, 6, 7, 8 and Annex A 8.1 Annex B includes suggested formatfor Certificates for animal materials to be used for medical devices. Annex C offers advice on theassessment of veter
31、inary services. 4, 5, 6, 7, 8 and Annex A 8.2 Annex B includes suggested formatfor Certificates for animal materials to be used for medical devices. Annex C offers advice on theassessment of veterinary services. 4, 5, 6, 7, 8 and Annex A Annex I of Commission Regulation No 722/2012 WARNING Other req
32、uirements and other EU Directives may be applicable to the product(s)falling within the scope of this standard.BS EN ISO 22442-2:2015BS EN ISO 22442-2:2015 ISO 2015Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handlingDispositifs mdicaux
33、utilisant des tissus animaux et leurs drivs Partie 2: Contrles de lorigine, de la collecte et du traitementINTERNATIONAL STANDARDISO22442-2Second edition2015-11-01Reference numberISO 22442-2:2015(E)BS EN ISO 22442-2:2015ISO 22442-2:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT I
34、SO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permis
35、sion. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS EN ISO 22442-2:2015ISO 2
36、2442-2:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 24.1 General . 24.2 Quality system elements . 24.3 Procedures 34.4 Personnel . 34.5 Current regulatory requirements and guidance 45 Sourcing . 45.1 General . 45.2 Species and
37、 strain . 45.3 Geography . 45.4 Inspection 45.5 Certification . 55.6 Traceability 56 Collection 57 Handling 68 Storage and transport . 6Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials . 7Annex B (informative) Certification
38、 and attestation 12Annex C (informative) Veterinary services .14Bibliography .15 ISO 2015 All rights reserved iiiContents PageBS EN ISO 22442-2:2015ISO 22442-2:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member b
39、odies). The 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 a
40、nd non-governmental, 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 d
41、escribed in 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 draw
42、n 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on t
43、he ISO list 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 meaning of ISO specific terms and expressions related to conformity assessment
44、, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 194, Biological and clinical evaluation of medical devices, Subcommittee SC 1,
45、 Tissue product safety.This second edition cancels and replaces the first edition (ISO 22442-2:2007), of which it constitutes a minor revision.ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues and their derivatives: Part 1: Application of ris
46、k management Part 2: Controls on sourcing, collection and handling Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) age
47、nts and validation assays for those processes Technical Reportiv ISO 2015 All rights reservedBS EN ISO 22442-2:2015ISO 22442-2:2015(E)IntroductionCertain medical devices utilize materials of animal origin.Animal tissues and their derivatives are used in the design and manufacture of medical devices
48、to provide performance characteristics that have been chosen for advantages over non-animal based materials. The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g. bovine/porcine heart valves, bone substitutes for
49、 use in dental or orthopaedic applications, haemostatic devices), can be a product coating or impregnation (e.g. collagen, gelatine, heparin), or can be used in the device manufacturing process (e.g. tallow derivatives such as oleates and stearates, foetal calf serum, enzymes, culture media).Tissues and derivatives for use in medical devices are typically obtained by the manufacturer from a range of sources such as animal herds or flocks and commercial harvesting (including fishing). Some specialized industries also process mate
