DIN EN ISO 14971-2013 Medical devices - Application of risk management to medical devices (ISO 14971 2007 Corrected version 2007-10-01) German version EN ISO 14971 2012《医疗器械 风险管理在医.pdf

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1、April 2013 Translation by DIN-Sprachendienst.English price group 31No 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

2、11.040.01!$I“1999338www.din.deDDIN EN ISO 14971Medical devices Application of risk management to medical devices(ISO 14971:2007, Corrected version 2007-10-01);English version EN ISO 14971:2012,English translation of DIN EN ISO 14971:2013-04Medizinprodukte Anwendung des Risikomanagements auf Medizinp

3、rodukte (ISO 14971:2007, korrigierteFassung 2007-10-01);Englische Fassung EN ISO 14971:2012,Englische bersetzung von DIN EN ISO 14971:2013-04Dispositifs mdicaux Application de la gestion des risques aux dispositifs mdicaux(ISO 14971:2007, Version corrige de 2007-10-01);Version anglaise EN ISO 14971:

4、2012,Traduction anglaise de DIN EN ISO 14971:2013-04SupersedesDIN EN ISO 14971:2009-10www.beuth.deDocument comprises 103 pagesIn case of doubt, the German-language original shall be considered authoritative.04.13DIN EN ISO 14971:2013-04 2 A comma is used as the decimal marker. National foreword This

5、 document (EN ISO 14971:2012) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medic

6、al devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-13 AA Qualittsmanagement und entsprechende allgemeine Aspekte fr Medizinprodukte. A Special Task Force (STF)

7、 was set under the auspices of the CEN Technical Board Chairman to review the EU Commissions rejection in November 2010 of a number of European harmonized standards on medical devices, as well as the Swedish delegations related rejection in February 2011 of the European harmonized standard EN ISO 13

8、485. The Task Force primarily dealt with Annex Z in each of these standards on the relationship between the standard and the relevant EU Directives; according to the EU Commission this relationship had not been correctly described. The Task Force also revised Annexes ZA to ZC to EN ISO 14971 which t

9、ogether with the modified European Foreword were adopted in May 2012 according to Resolution CEN/BT C39/2012 and then published in July 2012 as a new edition of EN ISO 14971:2012. It was thus necessary to publish a new edition of DIN EN ISO 14971, which contains the modified European Foreword and th

10、e revised Annexes ZA to ZC. Working Committee NA 063-01-13 AA voted against the point relating to Annexes ZA to ZC for the following reasons: These Annexes do not take into consideration the many references in the preambles of the Medical Devices Directive and its amendments to the use of standards

11、to meet the essential requirements laid down in the directives. The Working Committee is thus concerned that the legally approved principle of using safety technology as a means of minimizing risks will no longer be accepted, or that risks will have to be reduced to an absolute minimum regardless of

12、 the consequences of exhausting all conceivable technical possibilities, even going beyond a level of safety that reflects the current state-of-the-art. According to the Working Committee this puts into question the practical implementability of the interpretations of the Directives given in the “Z”

13、 Annexes here. Please note that the text of ISO 14971:2007 (Corrected version 2007-10-01), which forms the body of this European Standard, has not been changed. The specified requirements as laid down in DIN EN ISO 14971:2009-10 and DIN EN ISO 14971:2007-07 including Corrigendum 1:2007-10 have not b

14、een changed. Footnote “1)” in the original ISO Standard has been omitted because the ISO Foreword is not included in the EN adoption of the International Standard, EN ISO 14971. The footnotes to 2.27 “use error” and to the Bibliography reflect the state as of March 2007, the publication date of the

15、original ISO Standard. The following changes have occurred since then: IEC 62366, referenced in the footnote to 2.27 and in the Bibliography 30, was published in October 2007; ISO 17593, referenced in the Bibliography 16, was published in April 2007. DIN EN ISO 14971:2013-04 3 The DIN Standards corr

16、esponding to the International Standards referred to in this document are as follows: ISO 9000-3:1997 (replaced by ISO/IEC 90003:2004-02) No national standard available ISO 9000 DIN EN ISO 9000 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-17 DIN EN ISO 10993-17 ISO 13485 D

17、IN EN ISO 13485 ISO/TR 14969 DIN-Fachbericht CEN ISO/TR 14969 ISO 14155-1 (combined with Part 2 in 2011) DIN EN ISO 14155 ISO 14155-2 (combined with Part 1 in 2011) DIN EN ISO 14155 ISO 15189 DIN EN ISO 15189 ISO 15197 DIN EN ISO 15197 ISO 17511 DIN EN ISO 17511 ISO 18153 DIN EN ISO 18153 ISO 18113-

18、1 DIN EN ISO 18113-1 ISO 22442 (all parts) DIN EN ISO 22442 (all parts) IEC 60601-1:2005 DIN EN 60601-1 IEC 60601-1-4 DIN EN 60601-1-4 IEC 60601-1-6 DIN EN 60601-1-6 IEC 60601-1-8 DIN EN 60601-1-8 Amendments This standard differs from DIN EN ISO 14971:2009-10 as follows: a) the European foreword and

19、 Annexes ZA, ZB and ZC have been replaced. Previous editions DIN EN 1441: 1998-01 DIN EN ISO 14971: 2001-03, 2007-07, 2009-10 DIN EN ISO 14971/A1: 2003-10 DIN EN ISO 14971 Corrigendum 1: 2007-10 DIN EN ISO 14971:2013-04 4 National Annex NA (informative) Bibliography DIN EN ISO 9000, Quality manageme

20、nt systems Fundamentals and vocabulary DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements DIN EN ISO 10993-17, Biological evaluati

21、on of medical devices Part 17: Establishment of allowable limits for leachable substances DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN-Fachbericht CEN ISO/TR 14969, Medical devices Quality management systems Guidance on the application of ISO

22、13485:2003 DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 15189, Medical laboratories Requirements for quality and competence DIN EN ISO 15197, In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for sel

23、f-testing in managing diabetes mellitus DIN EN ISO 17511, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials DIN EN ISO 18113-1, In vitro diagnostic medical devices Information supplied

24、 by the manufacturer (labelling) Part 1: Terms, definitions and general requirements DIN EN ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control ma

25、terials DIN EN ISO 22442 standards series, Medical devices utilizing animal tissues and their derivatives DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-4, Medical electrical equipment Part 1-4: General requirements

26、 for safety Collateral standard: Programmable electrical medical systems DIN EN 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability DIN EN 60601-1-8, Medical electrical equipment Part 1-8: General requiremen

27、ts for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14971 July 2012 ICS 11.040.01 Supersedes EN ISO 14971:

28、2009 English version Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) Dispositifs mdicaux - Application de la gestion des risques aux dispositifs mdicaux (ISO 14971:2007, Version corrige de 2007-10-01) Medizinprodukte - Anwendung des

29、Risikomanagements auf Medizinprodukte (ISO 14971:2007, korrigierte Fassung 2007-10-01) This European Standard was approved by CEN on 16 May 2012. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the

30、 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 and CENELEC member. This European Standard exists in three official versions (En

31、glish, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bo

32、dies and national electrotechnical committees 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

33、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN/CENELEC Ref. No. EN ISO 14971:2012 EContents Page Foreword. 3 Introduction 4 1 Scope . 5 2 Terms and definitions. 5 3 General requ

34、irements for risk management 9 3.1 Risk management process 9 3.2 Management responsibilities 11 3.3 Qualification of personnel . 11 3.4 Risk management plan. 11 3.5 Risk management file. 12 4 Risk analysis . 12 4.1 Risk analysis process 12 4.2 Intended use and identification of characteristics relat

35、ed to the safety of the medical device. 13 4.3 Identification of hazards 13 4.4 Estimation of the risk(s) for each hazardous situation. 13 5 Risk evaluation 14 6 Risk control . 15 6.1 Risk reduction . 15 6.2 Risk control option analysis 15 6.3 Implementation of risk control measure(s) 15 6.4 Residua

36、l risk evaluation. 16 6.5 Risk/benefit analysis 16 6.6 Risks arising from risk control measures 16 6.7 Completeness of risk control 16 7 Evaluation of overall residual risk acceptability . 17 8 Risk management report 17 9 Production and post-production information 17 Annex A (informative) Rationale

37、for requirements . 19 Annex B (informative) Overview of the risk management process for medical devices 27 Annex C (informative) Questions that can be used to identify medical device characteristics that could impact on safety. 29 Annex D (informative) Risk concepts applied to medical devices 36 Ann

38、ex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations . 53 Annex F (informative) Risk management plan 58 Annex G (informative) Information on risk management techniques. 60 Annex H (informative) Guidance on risk management for in vitro diagnostic medical de

39、vices 64 Annex I (informative) Guidance on risk analysis process for biological hazards. 80 Annex J (informative) Information for safety and information about residual risk . 82 Annex ZA (informative) Relationship between this European Standard and Requirements of EU Directive 93/42/EEC on Medical D

40、evices . Annex ZB (informative) Relationship between this European Standard and Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices Annex ZC (informative) Relationship between this European Standard and Requirements of EU Directive 98/79/EC on In Vitro Diagnostic Medical De

41、vices Bibliography . EN ISO 14971:2012 (E) DIN EN ISO 14971:2013-04 284899397Foreword The text of ISO 14971:2007, Corrected version 2007-10-01, has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” of the International Organiza

42、tion for Standardization (ISO) and has been taken over as EN ISO 14971:2012 by Technical Committee CEN-CLC/TC 3 “Quality management and corresponding general aspects for medical devices”, the Secretariat of which is held by NEN. This European Standard shall be given the status of a national standard

43、, either by publication of an identical text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. This document supersedes EN ISO 14971:2009. Attention is drawn to the possibility that some of the elements of this docu

44、ment 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requiremen

45、ts of EU Directives 93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices and 98/79/EC on In Vitro Diagnostic Devices. For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are an integral part of this document. According to the CEN/CENELEC Intern

46、al Regulations, the national standards organisations 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, Ire

47、land, 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 14971:2007, Corrected version 2007-10-01, has been approved by CEN as an EN ISO 14971:2

48、012 without any modification. EN ISO 14971:2012 (E) DIN EN ISO 14971:2013-04 3 Introduction The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with th

49、e use of medical devices. This International Standard was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this International Standard could be used as informative guidance in developing and maintaining a risk management system and process. This International Standard deals with pro