EN ISO 14971-2012 en Medical devices - Application of risk management to medical devices《医疗器械 医疗器械风险管理的应用》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14971:2012Medical devices Applicationof risk management to medicaldevices (ISO 14971:2007,Corrected version 2007-10-01)BS EN ISO 14971:2012 BRITISH STANDARDNational for

2、ewordThis British Standard is the UK implementation of EN ISO 14971:2012. It is identical to ISO 14971:2007. It supersedes BS EN ISO 14971:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/210/4, Risk analysis for Medical Devices.A list of organi

3、zations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 201

4、2ISBN 978 0 580 79952 5ICS 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2012.Amendments issued since publicationDate T e x t a f f e c t e d

5、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14971 July 2012 ICS 11.040.01 Supersedes EN ISO 14971:2009 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 r

6、isques aux dispositifs mdicaux (ISO 14971:2007, Version corrige de 2007-10-01) Medizinprodukte - Anwendung des 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

7、 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 may be obtained on application to the CEN-CENELEC M

8、anagement Centre or to any CEN and CENELEC 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 and CENELEC member into its own language and notified to the CEN-CENELEC Manage

9、ment Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germa

10、ny, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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

11、 ISO 14971:2012 E4 Annex ZA (informative) Relationship between this European Standard and Requirements of EU Directive 93/42/EEC on Medical Devices 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 me

12、ans of conforming to Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Within the limits of the scope of this standard (Clause 1 of EN ISO 14971:2012), compliance with the clauses of this standard confers a presumption of conformity with requirements of that Directive and asso

13、ciated EFTA regulations, 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. This Annex ZA explains to which requirements, under which conditions and to what extent presumption of

14、 conformity can be claimed. Whilst only a limited number of requirements is covered just by the application of this standard, authorities in charge of medical devices strongly recommend using this standard. The standard leads, according to experience of the authorities, to a higher degree of complia

15、nce with legal obligations. EN ISO 14971:2012 provides a process for managing risks associated with medical devices. Because this standard describes an ongoing, lifecycle process applicable in part or in all to the Essential Requirements of Directive 93/42/EEC on Medical Devices, it is very exceptio

16、nally not meaningful to link individual clauses of the standard to specific corresponding Essential Requirements. Compliance with all the normative clauses in EN ISO 14971 will ensure that a process is in place to address general risk management aspects related to medical devices, which are included

17、 in the Essential Requirements. However, because this is an international standard, intended to be applicable in jurisdictions all over the world, it is not the primary goal of the standard to cover exactly any of the European Essential Requirements. Therefore, for all of the Essential Requirements,

18、 conformity is not entirely achieved by complying only with the requirements specified in this standard. Manufacturers and conformity assessment bodies will need to feed the Essential Requirements into the risk management process provided by the standard. Explanation on the correspondence of the sta

19、ndard and the Essential Requirements is included in Table ZA.1. Further explanation on content deviations between the standard and the ERs is provided below the table. BS EN ISO 14971:2012 EN ISO 14971:2012 (E) 5Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(

20、s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 1-9 1 ER 1 is not directly covered by EN ISO 14971, since the standard does not provide requirements on design and manufacture. However, the standard provides a tool to generate the information th

21、at is a necessary preliminary step for a manufacturer to demonstrate that the device is in conformity with ER 1. For content deviations, see points 1, 2, 3, 4 below. 1-9 2 - The second sentence of ER 2 is partly covered by 6.2. For content deviations, see points 1, 2, 3, 5, 6, 7 below. - The other p

22、arts of ER 2 are not directly covered by EN ISO 14971, since the standard does not provide requirements on design and construction, nor does it apply the concept of safety principles as intended in the MDD. However, the standard provides a tool to generate the information that is a necessary prelimi

23、nary step for a manufacturer to demonstrate that the device is in conformity with ER 2. 1-9 4 ER 4 is not directly covered by EN ISO 14971, since the standard does not apply the concept of safety principles as intended in the MDD. However, the standard provides a tool to generate the information tha

24、t is a necessary preliminary step for a manufacturer to demonstrate that the device is in conformity with ER 4. 1-9 5 ER 5 is not directly covered by EN ISO 14971, since the standard does not provide requirements on design, manufacture or packaging. However, the standard provides a tool to generate

25、the information that is a necessary preliminary step for a manufacturer to demonstrate that the device is in conformity with ER 5. BS EN ISO 14971:2012 EN ISO 14971:2012 (E) 6 6.4, 6.5 and 7 6 ER 6 is covered. However, for content deviations, see points 1, 2, 3, 4 below. 1-9 7.1 ER 7.1 is only partl

26、y covered by EN ISO 14971, since the standard does not provide requirements on design and manufacture and does not cover performances and characteristics related thereto. Furthermore, it does not provide specific requirements on the items that must be paid particular attention. However, the standard

27、 provides a tool to generate the information that is a necessary preliminary step for a manufacturer to demonstrate that the device is in conformity with ER 7.1. For content deviations, see points 1 to 7 below. Content deviationsThe following aspects have been identified where the standard deviates

28、or might be understood as deviating from the Essential Requirements: 1. Treatment of negligible risks: a) According to standard ISO 14971, the manufacturer may discard negligible risks1. b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks, regardless of their dimens

29、ion, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device. c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 2 of Annex I to Directive 93/42/EEC. 2. Discretionary power of manufa

30、cturers as to the acceptability of risks: a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for risk acceptability2and that only non-acceptable risks have to be integrated into the overall risk-benefit analysis3. b) However, Sections 1 and 2 of Annex I to D

31、irective 93/42/EEC require that all risks have to be reduced as far as possible and that all risks combined, regardless of any “acceptability“ assessment, need to be balanced, together with all other risks, against the benefit of the device. c) Accordingly, the manufacturer may not apply any criteri

32、a of risk acceptability prior to applying Sections 1 and 2 of Annex I to Directive 93/42/EEC. 1This is explicitly stated in D.8.2. 2Sections 5, 6.4, 6.5, 7: reference to the criteria set-up in the management plan which is under the discretion of the manufacturer (see Sections 3.2, 3.4d). See also D.

33、4: “This International Standard does not specify acceptable risk. That decision is left to the manufacturer.“ 3See D.6.1.BS EN ISO 14971:2012 EN ISO 14971:2012 (E) 73. Risk reduction “as far as possible“ versus “as low as reasonably practicable“: a) Annex D.8 to ISO 14971, referred to in 3.4, contai

34、ns the concept of reducing risks “as low as reasonably practicable“ (ALARP concept). The ALARP concept contains an element of economic consideration. b) However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular Essential Requirements require risks to be reduced

35、“as far as possible“ without there being room for economic considerations. c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations. 4. Discretion as to whether a risk-benefit analysis needs to take place: a) 6.5 of ISO 14971 says: “If

36、the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk.“ Clause 7

37、 of ISO 14971 says: “If the overall residual risk is not judged acceptable using the criteria established in the risk management plan, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk.“ Both quotes

38、imply that an overall risk-benefit analysis does not need to take place if the overall residual risk is judged acceptable when using the criteria established in the risk management plan. Equally, D.6.1 says: “A risk/benefit analysis is not required by this International Standard for every risk.“ b)

39、According to Section 1 of Annex I to Directive 93/42/EEC, an overall risk-benefit analysis must take place in any case, regardless of the application of criteria established in the management plan of the manufacturer. Furthermore, Section 6 of Annex I to Directive 93/42/EEC requires undesirable side

40、-effects to “constitute an acceptable risk when weighed against the performance intended“. c) Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases. 5. Discre

41、tion as to the risk control options/measures: a) 6.2 of ISO 14971 obliges the manufacturer to “use one or more of the following risk control options in the priority order listed: (a) inherent safety by design; (b) protective measures in the medical device itself or in the manufacturing process; (c)

42、information for safety“ and leaves a discretion as to the application of these three options: shall the second or third control option still be used when the first was used? 6.4 indicates that further risk control measures do not need to be taken if, after applying one of the control options, the ri

43、sk is judged acceptable according to the criteria of the risk management plan. b) However, the second sentence of Section 2 of Annex I to Directive 93/42/EEC requests “to conform to safety principles, taking account of the generally acknowledged state of the art“ and “to select the most appropriate

44、solutions“ by applying cumulatively what has been called “control options“ or “control mechanisms“ in the standard. c) Accordingly, the manufacturer must apply all the “control options“ and may not stop his endeavours if the first or the second control option has reduced the risk to an “acceptable l

45、evel“ (unless the additional control option(s) do(es) not improve the safety). 6. Deviation as to the first risk control option: a) 6.2 of ISO 14971 obliges the manufacturer to “use one or more of the following risk control options in the priority order listed: (a) inherent safety by design “ withou

46、t determining what is meant by this term. b) However, the first indent of the second sentence of Section 2 of Annex I to Directive 93/42/EEC requires to “eliminate or reduce risks as far as possible (inherently safe design and construction)“. c) Accordingly, as the Directive is more precise than the

47、 standard, manufacturers must apply the former and cannot rely purely on the application of the standard. 7. Information of the users influencing the residual risk: a) The residual risk is in 2.15 and in 6.4 of ISO 14971 defined as the risk remaining after application of the risk control measures. 6

48、.2 of ISO 14971 regards “information for safety“ to be a control option. BS EN ISO 14971:2012 EN ISO 14971:2012 (E) 8 b) However, the last indent of Section 2 of Annex I to Directive 93/42/EEC says that users shall be informed about the residual risks. This indicates that, according to Annex I to Di

49、rective 93/42/EEC and contrary to the concept of the standard, the information given to the users does not reduce the (residual) risk any further. c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users. Conformity assessment proceduresEN ISO 14971 can also be used to support the following parts of conformity assessment procedures in the European Medical Devices Directives: an adeq