DIN EN ISO 22442-2-2016 Medical devices utilizing animal tissues and their derivatives - Part 2 Controls on sourcing collection and handling (ISO 22442-2 2015) German version EN IS.pdf

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1、May 2016 English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.100.99!%SM5“2484218www.din.deDIN

2、EN ISO 22442-2Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015);English version EN ISO 22442-2:2015,English translation of DIN EN ISO 22442-2:2016-05Tierische Gewebe und deren Derivate, die zur Herstellung von Medi

3、zinprodukten eingesetzt werden Teil 2: Kontrollen der Beschaffung, Materialgewinnung und Handhabung (ISO 22442-2:2015);Englische Fassung EN ISO 22442-2:2015,Englische bersetzung von DIN EN ISO 22442-2:2016-05Dispositifs mdicaux utilisant des tissus animaux et leurs drivs Partie 2: Contrles de lorigi

4、ne, de la collecte et du traitement (ISO 22442-2:2015);Version anglaise EN ISO 22442-2:2015,Traduction anglaise de DIN EN ISO 22442-2:2016-05SupersedesDIN EN ISO 22442-2:2008-03www.beuth.deDocument comprises 27 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original sh

5、all be considered authoritative.04.16 DIN EN ISO 22442-2:2016-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22442-2:2015) has been prepared by Technical Committee CEN/TC 316 “Medical devices utilizing tissues” (Secretariat: DIN, Germany) in collaboration with Te

6、chnical Committee ISO/TC 194 “Biological and clinical evaluation of medical devices”, Subcommittee SC 1 “Tissue product safety” (both secretariats are held by DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committe

7、e Optics and Precision Mechanics), Working Committee NA 027-02-21 AA Medizinische Produkte auf Basis des Tissue Engineering. ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues and their derivatives: null Part 1: Application of risk management

8、null Part 2: Controls on sourcing, collection and handling null Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents null Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) a

9、gents and validation assays for those processes Technical Report The DIN Standard corresponding to the International Standard referred to in Clause 2 of this standard is as follows: ISO 22442-1 DIN EN ISO 22442-1 NOTE on the terms used in the German version of this document: “Sourcing” has been tran

10、slated as “Beschaffung” “Procurement” is a synonym for “Sourcing” and has also been translated as “Beschaffung” “Source” has been translated as “Herkunft” “Collection” has been translated as “Materialgewinnung”. nderungen This standard differs from DIN EN ISO 22442-2:2008-03 as follows: a) normative

11、 references have been updated; b) Annex A “Additional requirements relating to the application of ISO 22442-2 to bovine-sourced materials” has been revised and the sources of information on the BSE risk with regard to certain countries have been updated; c) Annex ZA (informative) “Relationship betwe

12、en this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices” has been updated; d) the standard has been editorially revised and harmonized with current rules of presentation. Previous editions DIN EN 12442-2: 2001-01 DIN EN ISO 22442-2: 2008-03 DIN EN ISO 22

13、442-2:2016-05 3 National Annex NA (informative) Bibliography DIN EN ISO 22442-1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management DIN EN ISO 22442-2:2016-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IS

14、O 22442-2 November 2015 ICS 11.100.99 Supersedes EN ISO 22442-2:2007English 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: Co

15、ntrles de lorigine, de la collecte et du traitement (ISO 22442-2:2015) Tierische 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 o

16、n 31 October 2015. 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 references concerning such national standards m

17、ay 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 CEN member into its own language and notified

18、 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 Macedonia, France, Germany, Greece, Hungary, Icelan

19、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, 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 Manageme

20、nt Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22442-2:2015 EEuropean foreword .3Introduction 81 Scope . 92 Normative references 93 Terms and definitions . 94 General requireme

21、nts 104.1 General 104.2 Quality system elements 104.3 Procedures . 114.4 Personnel 114.5 Current regulatory requirements and guidance . 125 Sourcing 125.1 General 125.2 Species and strain 125.3 Geography 125.4 Inspection . 125.5 Certification 135.6 Traceability . 136 Collection . 137 Handling . 148

22、Storage and transport 14Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials 15Annex B (informative) Certification and attestation 20Annex C (informative) Veterinary services .22Bibliography .23Contents PageRelationship between

23、 this European Standard and the EssentialRequirements of EU Directive 93/42/EEC5 Foreword 7.Annex ZA (informative)DIN EN ISO 22442-2:2016-05 EN ISO 22442-2:2015 (E)2 European foreword This document (EN ISO 22442-2:2015) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of me

24、dical devices“ in collaboration with Technical Committee CEN/TC 316 “Medical devices utilizing tissues” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May

25、 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 may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights.

26、 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 Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which

27、is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, fo

28、r 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 acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard

29、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, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole

30、 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 standard Equivalent dated standard EN ISO ISO 22442-1 EN ISO 22442-1:2016 ISO 22442-1:2016 According to the CEN-CENELEC Internal Reg

31、ulations, 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 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

32、Italy, Latvia, Lithuania, Luxembourg, Malta, DIN EN ISO 22442-2:2016-05 EN ISO 22442-2:2015 (E) 3 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22442-2:2015 has been approved by CEN as

33、 EN ISO 22442-2:2015 without any modification. DIN EN ISO 22442-2:2016-05 EN ISO 22442-2:2015 (E)4 Annex ZA (informative) Relationship between this European 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

34、European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements of Directive 93/42/EEC, concerning medical devices, as amended by Commission Regulation (EU) No722/2012 in relation to detailed specifications regarding requirements for medical

35、 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 implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers

36、, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA Regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process

37、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 the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers p

38、olicy 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 normative references according to the table of references in the European foreword, replacing the references in the core text. NOT

39、E 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. DIN EN ISO 22442-2:2016-05 EN ISO 22442-2:2015 (E) 5 Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC as amended by Commission Regulation (EU)

40、 No 722/2012 Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC as amended by Commission Regulation No 722/2012 Qualifying remarks/Notes 4, 5, 6, 7, 8 and Annex A 7.1 Annex B includes suggested format for Certificates for animal materials to be

41、 used for medical devices. Annex C offers advice on the assessment of veterinary services. 4, 5, 6, 7, 8 and Annex A 7.2 Annex B includes suggested format for Certificates for animal materials to be used for medical devices. Annex C offers advice on the assessment of veterinary services. 4, 5, 6, 7,

42、 8 and Annex A 8.1 Annex B includes suggested format for Certificates for animal materials to be used for medical devices. Annex C offers advice on the assessment of veterinary services. 4, 5, 6, 7, 8 and Annex A 8.2 Annex B includes suggested format for Certificates for animal materials to be used

43、for medical devices. Annex C offers advice on the assessment of veterinary services. 4, 5, 6, 7, 8 and Annex A Annex I of Commission Regulation No 722/2012 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. DIN EN ISO 224

44、42-2:2016-05 EN ISO 22442-2:2015 (E)6 ForewordISO (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

45、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 closely with the International Electrotech

46、nical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO d

47、ocuments 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 possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held respon

48、sible 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 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