EN 1041-2008 en Information supplied by the manufacturer of medical devices (Incorporates Amendment A1 2013)《医疗装置制造商提供的信息》.pdf

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1、BSEN1041:2008ICS01.110;11.040.01;11.120.01NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDInformationsuppliedbythemanufacturerofmedicaldevicesBS EN 1041:2008 +A1:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1041:2008+A1 September 2013 ICS 01.110; 11.040.01; 11.

2、120.01 Supersedes EN 1041:2008 English version Information supplied by the manufacturer of medical devices Informations fournies par le fabricant de dispositifs mdicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European Standard was approved by CEN on 4 July 200

3、8 and includes Amendment 1 approved by CEN on 11 July 2013. CEN and CENELEC 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 bibliograp

4、hical 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 (English, French, German). A version in any other language made by translation under the

5、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 bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia,

6、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, Switzerland, Turkey and United

7、 Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 1041:2008+A1:2013 E BS EN 1041:2008+A1:2013ISBN 978 0 580 80873 9Amendm

8、ents/corrigenda issued since publicationDate Comments31 October 2013 Implementation of CEN/CENELEC amendment A1:2013This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2008 The British Standards Institution 2013. Published by BSI Standa

9、rds Limited 2013National forewordThis British Standard is the UK implementation of EN 1041:2008+A1:2013. It supersedes BS EN 1041:2008, which will be withdrawn on 31 March 2014.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes t

10、o CEN/CENELEC text carry the number of the CEN amendment. For example, text altered by CEN/CENELEC amendment A1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for Medical Devices, to Subcommit

11、tee CH/210/3, General terminology and symbols for Medical Devices.A list of organizations represented on this subcommittee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applica

12、tion.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1041:2008+A1 September 2013 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:2008 English version Information supplied by the manufacturer of medical devices

13、Informations fournies par le fabricant de dispositifs mdicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European Standard was approved by CEN on 4 July 2008 and includes Amendment 1 approved by CEN on 11 July 2013. CEN and CENELEC members are bound to comply wit

14、h 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 Manag

15、ement 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 Management

16、 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, Germany,

17、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 2013 CEN/CENELEC All rights of e

18、xploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 1041:2008+A1:2013 E EN 1041:2008+A1:2013 (E) 2 Contents Page Foreword 3 Introduction . 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Requirements . 6 4.1 Gen

19、eral 6 4.2 Units, symbols and colours 6 4.3 Language and country identifiers 7 4.4 Dates . 7 4.5 Device nomenclature . 7 4.5.1 Identifiers of nomenclature . 7 4.5.2 Device common terms 7 4.5.3 Batch code; lot number; batch number; lot code 7 5 Requirements for provision of information 7 5.1 General

20、7 5.1.1 !Safe and effective use of the device“ . 7 5.1.2 !Address required under medical devices directives“ . 7 5.2 Specific requirements . 8 5.2.1 Applicability 8 5.2.2 Accessibility . 8 5.2.3 Legibility . 8 5.2.4 Availability 9 5.2.5 Security . 9 5.2.6 Changes to information provided 9 6 Document

21、ation . 9 Annex A (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended 10 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) . 10 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC) 16 Annex B (inform

22、ative) Guidance on alternative labelling for instructions for use (IFU) 20 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) 21 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC) 22 Annex ZA (informative) Relationship bet

23、ween this European Standard and the Essential Requirements of EU Directive 93/42/EC 23 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC 24 Bibliography 25 EN 1041:2008+A1:2013 (E) 3 Foreword This document (EN 1041:2008+A1:201

24、3) has been prepared 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 !deleted text“ shall be given the status of a national standard, either by publication of an identical

25、text or by endorsement, at the latest by March 2014 and conflicting national standards shall be withdrawn at the latest by March 2014. !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 responsib

26、le for identifying any or all such patent rights.“ This document includes Amendment 1 approved by CEN on 11 July 2013. This document supersedes !EN 1041:2008“. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This document has been prepared under a

27、 mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B. Annex A provides practical guidance about the implementation of the essential re

28、quirements of the applicable Directives. For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this E

29、uropean Standard: 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, Portugal, Romania, Slovakia,

30、Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1041:2008+A1:2013EN 1041:2008+A1:2013 (E)EN 1041:2008+A1:2013 (E) 2 Contents Page Foreword 3 Introduction . 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Requirements . 6 4.1 General 6 4.2 Units, symbols

31、and colours 6 4.3 Language and country identifiers 7 4.4 Dates . 7 4.5 Device nomenclature . 7 4.5.1 Identifiers of nomenclature . 7 4.5.2 Device common terms 7 4.5.3 Batch code; lot number; batch number; lot code 7 5 Requirements for provision of information 7 5.1 General 7 5.1.1 !Safe and effectiv

32、e use of the device“ . 7 5.1.2 !Address required under medical devices directives“ . 7 5.2 Specific requirements . 8 5.2.1 Applicability 8 5.2.2 Accessibility . 8 5.2.3 Legibility . 8 5.2.4 Availability 9 5.2.5 Security . 9 5.2.6 Changes to information provided 9 6 Documentation . 9 Annex A (informa

33、tive) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended 10 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) . 10 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC) 16 Annex B (informative) Guidance on alterna

34、tive labelling for instructions for use (IFU) 20 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) 21 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC) 22 Annex ZA (informative) Relationship between this European Standar

35、d and the Essential Requirements of EU Directive 93/42/EC 23 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC 24 Bibliography 25 EN 1041:2008+A1:2013 (E) 3 Foreword This document (EN 1041:2008+A1:2013) has been prepared by Te

36、chnical 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 !deleted text“ shall be given the status of a national standard, either by publication of an identical text or by endorsement, at

37、 the latest by March 2014 and conflicting national standards shall be withdrawn at the latest by March 2014. !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

38、all such patent rights.“ This document includes Amendment 1 approved by CEN on 11 July 2013. This document supersedes !EN 1041:2008“. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This document has been prepared under a mandate given to CEN by t

39、he European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B. Annex A provides practical guidance about the implementation of the essential requirements of the applicab

40、le Directives. For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria,

41、 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, S

42、witzerland, Turkey and the United Kingdom. BS EN 1041:2008+A1:2013EN 1041:2008+A1:2013 (E)EN 1041:2008+A1:2013 (E) 4 Introduction The first edition of this standard was drafted in a period when the Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) and the Medical Device Directive (MDD

43、) (93/42/EEC) were relatively new and the In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EEC) was not in existence. In addition, at the time the previous edition of this standard was adopted, the established method of providing information on, with, or otherwise in association with a dev

44、ice was by hard copy. Predominantly, this was printed copy on substrates such as paper, card, or plastic. Since the time of approval of the first edition of this standard on 18 January 1998, the MDD and AIMDD have been amended. In addition, other methods of provision of information have become freel

45、y available and widely used. The intention of this second edition is to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information as well as to update the requirements to reflect the changes to Directives 90/385/EEC

46、and 93/42/EEC. In this standard, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007. The guidance reflects the desire to take into account different methods of provision of information, and it is intended that it should, as far as possible, be suitable for future methods of pr

47、ovision of information. The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means

48、 by which compliance can be tested by regulatory and inspection agencies. The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC. Annex B provides guidance on alternative labelling. EN 1041:2008+A1:2013 (E) 5 1 Scope This !European Standard“

49、specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follo