1、May 2016 English price group 17No 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!%SM4“2484217www.din.deDIN
2、EN ISO 22442-1Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management (ISO 22442-1:2015);English version EN ISO 22442-1:2015,English translation of DIN EN ISO 22442-1:2016-05Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten ei
3、ngesetzt werden Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2015);Englische Fassung EN ISO 22442-1:2015,Englische bersetzung von DIN EN ISO 22442-1:2016-05Dispositifs mdicaux utilisant des tissus animaux et leurs drivs Partie 1: Application de la gestion des risques (ISO 22442-1:2015);Versi
4、on anglaise EN ISO 22442-1:2015,Traduction anglaise de DIN EN ISO 22442-1:2016-05SupersedesDIN EN ISO 22442-1:2008-03www.beuth.deDocument comprises 39 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 22442-1:201
5、6-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22442-1:2015) has been prepared by Technical Committee CEN/TC 316 “Medical devices utilizing tissues” (Secretariat: DIN, Germany) in collaboration with Technical Committee ISO/TC 194 “Biological and clinical evalua
6、tion 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 Committee Optics and Precision Mechanics), Working Committee NA 027-
7、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 null Part 2: Controls on sourcing, collection and handling n
8、ull 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) agents and validation assays for those processes Technical Re
9、port The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 14971 DIN EN ISO 14971 ISO 22442-2 DIN EN ISO 22442-2 ISO 22442-3 DIN EN ISO 22442-3 NOTE on the terms used in the German version of this do
10、cument: “Sourcing” has been translated 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”. Amendments This standard differs from DIN EN ISO 22442-1
11、:2008-03 as follows: a) normative references have been updated; b) the tables in Annex D “Information relevant to the management of TSE risk” for the risk categories have been supplemented and updated; c) Annex ZA (informative) “Relationship between this European Standard and the Essential Requireme
12、nts of EU Directive 93/42/EEC on Medical Devices” has been updated; d) the standard has been brought in line with the current rules of presentation. Previous editions DIN EN 12442-1: 2001-01 DIN EN ISO 22442-1: 2008-03 DIN EN ISO 22442-1:2016-05 3 National Annex NA (informative) Bibliography DIN EN
13、ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls
14、 on sourcing, collection and handling DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents DIN EN ISO 22442-1:2016-05 4 This page is intentional
15、ly blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22442-1 November 2015 ICS 11.100.99 Supersedes EN ISO 22442-1:2007English Version Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management(ISO 22442-1:2015) Dispositifs mdicaux utilisant
16、des tissus animaux et leurs drivs - Partie 1: Application de la gestion des risques (ISO 22442-1:2015) Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden -Teil 1: Anwendung des Risikomanagements(ISO 22442-1:2015) This European Standard was approved by CEN
17、 on 1 November 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
18、 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 CEN member into its own language and notifi
19、ed 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, Icel
20、and, 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 Manage
21、ment 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 22442-1:2015 EEuropean foreword .3Introduction 81 Scope . 92 Normative references 93 Terms and definitions 104 Risk management
22、process . 114.1 General 114.2 Risk analysis . 114.2.1 Identification of qualitative and quantitative characteristics related to the safety of medical devices . 114.2.2 Identification of hazards and hazardous situations . 124.3 Risk evaluation . 134.4 Risk control . 134.4.1 General. 134.4.2 Risk cont
23、rol for viruses and TSE agents . 134.4.3 Risk control of other hazards . 134.4.4 Residual risk evaluation . 144.5 Evaluation of overall residual risk acceptability . 144.5.1 General. 144.5.2 Documentation . 144.6 Production and post-production information system . 15Annex A (informative) Guidance on
24、 the application of this part of ISO 22442 . 16Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material 17Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents 19Ann
25、ex D (informative) Information relevant to the management of TSE risk .24Bibliography .33Contents PageAnnex ZA (informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC 5 Foreword .7DIN EN ISO 22442-1:2016-05 EN ISO 22442-1:2015 (E)2European fo
26、reword This document (EN ISO 22442-1:2015) 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 shall be
27、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 may be th
28、e 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 22442-1:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, a
29、nd 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 edition of th
30、e 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 contents can s
31、till 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, as listed
32、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. DIN EN ISO 22442-1:2016-05 EN ISO 22442-1:2015 (E)3 Table 1 Correlation between normative references and dated EN and ISO standards Normative r
33、eferences as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 14971 ISO 14971:2012 ISO 14971:2007 ISO 22442-2 EN ISO 22442-2:2016 ISO 22442-2:2016 ISO 22442-3 EN ISO 22442-3:2007 ISO 22442-3:2007 According to the CEN-CENELEC
34、 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 of Macedonia, France, Germany, Greece, Hungary, Icela
35、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22442-1:2015 has been approved by CEN as EN ISO 22442-1:2015 without any modific
36、ation. DIN EN ISO 22442-1:2016-05 EN ISO 22442-1:2015 (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 European Commission and the European Fre
37、e 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 devices utilizing tissues of animal ori
38、gin. 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, within the limits of the scope of this
39、 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 needs to be in compliance with Directive
40、 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 policy for determining acceptable risk mu
41、st 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. NOTE 4 When an Essential Requirement does n
42、ot appear in Table ZA.1, it means that it is not addressed by this European Standard. DIN EN ISO 22442-1:2016-05 EN ISO 22442-1:2015 (E)5 Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012 Clause(s)/subclause(s)
43、of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012 Qualifying remarks/notes 4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and Annex C 7.1 4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and Annex C 7.2 4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and Annex C 8.1 4.1, 4.2,
44、 4.3, 4.4, 4.5, 4.6 and Annex C 8.2 Annexes C and D Annex I of Commission Regulation (EU) No 722/2012 Annexes C and D are dedicated to TSE risk, but 4.1, 4.2, 4.3, 4.4 are also relevant. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope o
45、f this standard. DIN EN ISO 22442-1:2016-05 EN ISO 22442-1:2015 (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 technica
46、l 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 closely wit
47、h 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 in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed f
48、or 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 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
