BS EN ISO 22442-1-2015 Medical devices utilizing animal tissues and their derivatives Application of risk management《医疗设备用动物组织及其衍生物 风险管理的应用》.pdf

1、BSI Standards PublicationBS EN ISO 22442-1:2015Medical devices utilizing animal tissues and their derivativesPart 1: Application of risk managementBS EN ISO 22442-1:2015 BRITISH STANDARDNational forewordT h i s B r i t i s h S t a n d a r d i s t h e U K i m p l e m e n t a t i o n o f E N I S O 2 2

2、 4 4 2 - 1 : 2 0 1 5 . It supersedes BS EN ISO 22442-1:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee RGM/1, Regenerative medicine.A list of organizations represented on this committee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

3、does not purport to include all the 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 89818 1 ICS 11.100.99 Compliance with a British Standard cannot confer immunity fro

4、m legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22442-1 November 2015 ICS

5、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 des tissus animaux et leurs drivs - Partie 1: Application de la gestion des risques (ISO 22

6、442-1:2015) 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 on 1 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulat

7、ions 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 any CEN member.

8、 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 versions. CEN

9、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, Norway, Poland, Po

10、rtugal, 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 exploitation in any

11、form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22442-1:2015 EBS EN ISO 22442-1:2015EN ISO 22442-1:2015 (E) 3 European foreword This document (EN ISO 22442-1:2015) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices“ in col

12、laboration 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 2016 and conflicting

13、 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. This document supers

14、edes 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, and supports essential requirements of EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part o

15、f 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, for any use of this sta

16、ndard 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 text, this shall be u

17、nderstood 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 or in part) to which

18、 they apply. BS EN ISO 22442-1:2015EN ISO 22442-1:2015 (E) 4 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 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 14971 ISO

19、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 Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgi

20、um, 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzer

21、land, 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 modification. BS EN ISO 22442-1:2015EN ISO 22442-1:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirem

22、ents 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, concerning medical devices, as amended by Com

23、mission 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 implemented as a national standard in a

24、t 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 associated EFTA Regulations. NOTE 1 Where a r

25、eference 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 the lowest possible level, minimized

26、 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 normative references a

27、ccording 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 22442-1:2015EN ISO 22442-1:2015 (E) 6 Table ZA.1 Corresp

28、ondence between this International Standard and Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012 Clause(s)/subclause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC as amended by Commission Regulation (EU) No 722/2012 Qualifying remarks/notes

29、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, 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.

30、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 of this standard. BS EN ISO 22442-1:2015ISO 22442-1:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Risk mana

31、gement process 34.1 General . 34.2 Risk analysis 34.2.1 Identification of qualitative and quantitative characteristics related to the safety of medical devices 34.2.2 Identification of hazards and hazardous situations 44.3 Risk evaluation 54.4 Risk control 54.4.1 General 54.4.2 Risk control for viru

32、ses and TSE agents 54.4.3 Risk control of other hazards 54.4.4 Residual risk evaluation 64.5 Evaluation of overall residual risk acceptability 64.5.1 General 64.5.2 Documentation 64.6 Production and post-production information system 7Annex A (informative) Guidance on the application of this part of

33、 ISO 22442 8Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material . 9Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents 11Annex D (informative) Information rel

34、evant to the management of TSE risk .16Bibliography .25 ISO 2015 All rights reserved iiiContents PageBS EN ISO 22442-1:2015ISO 22442-1:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepa

35、ring 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-governmental, in l

36、iaison 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 in the ISO/IEC D

37、irectives, 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 possibility that

38、 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 list of patent dec

39、larations 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, as well as information

40、about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 194, Biological and clinical evaluation of medical devices, SC 1, Tissue product safety.This second ed

41、ition cancels and replaces the first edition (ISO 22442-1:2007), 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 risk management Part 2: Controls on sour

42、cing, 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) agents and validation assays for those p

43、rocesses Technical Reportiv ISO 2015 All rights reservedBS EN ISO 22442-1:2015ISO 22442-1:2015(E)IntroductionCertain medical devices utilize materials of animal origin.Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristic

44、s 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 use in dental or orthopaedic applica

45、tions, 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).ISO 14971 is a general standard which specif

46、ies a process for a manufacturer by identifying hazards and hazardous situations associated with medical devices, including in vitro medical devices, to estimate and evaluate the risks associated with those hazards, to control these risks and to monitor the effectiveness of the control throughout th

47、e life cycle. This part of ISO 22442 provides additional requirements and guidance for the evaluation of medical devices manufactured utilizing animal tissues or derivatives which are non-viable or rendered non-viable.This part of ISO 22442 is intended to cover medical devices including active impla

48、ntable medical devices such as implantable infusion pumps.This part of ISO 22442 does not apply to in vitro diagnostic devices.This part of ISO 22442 can only be used in combination with ISO 14971 and is not a “standalone” standard.To show compliance with this part of ISO 22442, its specified requir

49、ements should be fulfilled. The guidance given in the Notes and informative annexes is not normative and is not provided as a checklist for auditors. ISO 2015 All rights reserved vBS EN ISO 22442-1:2015BS EN ISO 22442-1:2015Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management1 ScopeThis part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifie