DIN EN 1041-2013 Information supplied by the manufacturer of medical devices German version EN 1041 2008+A1 2013《医疗器械制造商提供的信息 德文版本EN 1041-2008+A1-2013》.pdf

1、December 2013 Translation by DIN-Sprachendienst.English price group 14No 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).I

2、CS 01.110; 11.040.01; 11.120.01!%*zr“2078779www.din.deDDIN EN 1041Information supplied by the manufacturer of medical devices;English version EN 1041:2008+A1:2013,English translation of DIN EN 1041:2013-12Bereitstellung von Informationen durch den Hersteller von Medizinprodukten;Englische Fassung EN

3、 1041:2008+A1:2013,Englische bersetzung von DIN EN 1041:2013-12Informations fournies par le fabricant de dispositifs mdicaux;Version anglaise EN 1041:2008+A1:2013,Traduction anglaise de DIN EN 1041:2013-12SupersedesDIN EN 1041:2008-11www.beuth.deDocument comprises 28 pagesIn case of doubt, the Germa

4、n-language original shall be considered authoritative.11.13DIN EN 1041:2013-12 2 A comma is used as the decimal marker. National foreword This document (EN 1041:2008+A1:2013) has been prepared by Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devic

5、es” (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. The DIN Standard corresponding to

6、the International Standard referred to in this document is as follows: ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN 1041:2008-11 as follows: a) Subclause 5.1.2 “Address required under medical devices directives” has been added; b) normative references have been updated; c) the

7、Bibliography has been updated; Previous editions DIN EN 1041: 1998-04, 2008-11 National Annex NA (informative) Bibliography DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1041:2008+A1

8、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 Informations fournies par le fabricant de dispositifs mdicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European S

9、tandard 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 with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any al

10、teration. 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 (English, French, German). A version in any othe

11、r 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 bodies and national electrotechnical committees

12、 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, Portugal, Romania, Slovakia, Slovenia, Spai

13、n, Sweden, Switzerland, Turkey and United 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 EN 1041:20

14、08+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 and colours 6 4.3 Language and country identifiers 7 4.4 Dates . 7 4.5 Device nomenclature . 7 4.5.1 Identifiers of nomenclatu

15、re . 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 effective use of the device“ . 7 5.1.2 !Address required under medical devices directives“ . 7 5.2 Specific requirements . 8 5.2.1 App

16、licability 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 (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended 10 A.1 Requirements and guidance for medic

17、al 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 alternative labelling for instructions for use (IFU) 20 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EE

18、C) 21 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC) 22 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC 23 Annex ZB (informative) Relationship between this European Standar

19、d and the Essential Requirements of EU Directive 90/385/EC 24 Bibliography 25 DIN EN 1041:2013-12 EN 1041:2008+A1:2013 (E) 3 Foreword This document (EN 1041:2008+A1:2013) has been prepared by Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices”,

20、 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 the latest by March 2014 and conflicting national standards shall be withdrawn at the latest by March 201

21、4. !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 includes Amendment 1 approved by CEN on 11 July 2013. This document

22、 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 the European Commission and the European Free Trade Association, and supports essential requirements of EU

23、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 applicable Directives. For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral

24、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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic o

25、f Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 1041:2013-12 EN 1041:2008+A1:2013 (E) 4 Introduction The

26、 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) (93/42/EEC) were relatively new and the In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EEC) was not in existence. In ad

27、dition, 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 device was by hard copy. Predominantly, this was printed copy on substrates such as paper, card, or plastic. Since the time of approval

28、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 freely available and widely used. The intention of this second edition is to make available guidance for manufacturers of medical devices

29、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 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

30、 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 provision of information. The requirements and guidance will provide manufacturers with appropriate means to ensure that their provisio

31、n 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 by which compliance can be tested by regulatory and inspection agencies. The possibility of providing information by alternative mea

32、ns is foreseen in Directives 93/42/EEC and 90/385/EEC. Annex B provides guidance on alternative labelling. DIN EN 1041:2013-12 EN 1041:2008+A1:2013 (E) 5 1 Scope This !European Standard“ specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council

33、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 complemen

34、t 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 follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be

35、 supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied,

36、this standard does not provide derogation from these requirements for that country. 2 Normative references !The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For u

37、ndated references, the latest edition of the referenced document (including any amendments) applies.“ !deleted text“ EN ISO 3166-1,!1)“ Codes for the representation of names of countries and their subdivisions Part 1: Country codes (ISO 3166-1:2006) ISO 639-1, Codes for the representation of names o

38、f languages Part 1: Alpha-2 Code ISO 1000, SI units and recommendations for the use of their multiples and of certain other units ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times CEN/TR 15133, Nomenclature Collective terms and codes for groups

39、 of medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 batch; lot defined amount of material or a number of devices, including finished product and accessories, that is processed in one process or a series of related processes NO

40、TE The defined amount of material or number of devices will normally be associated with a unique statement of conformity to a defined quality specification. ! 1) EN ISO 3166-1 is currently impacted by the corrigendum EN ISO 3166-1:2006/AC:2008, Codes for the representation of names of countries and

41、their subdivisions Part 1: Country codes (ISO 3166-1:2006/Cor 1:2007).“ DIN EN 1041:2013-12 EN 1041:2008+A1:2013 (E) 6 3.2 batch code; lot number; batch number; lot code unique identifier associated with a single batch or lot (see 3.1) 3.3 alternative labelling any form of electronically accessible

42、information supplied by the manufacturer (see 3.4) related to a medical device such as CD/DVD-ROM, Internet or other mode 3.4 information supplied by the manufacturer all material, however provided, relating to the identification, technical description and use of a medical device that is intended to

43、 ensure the safe, effective and compliant use of the device NOTE Shipping documents and promotional material are excluded from this definition when identification, technical description and use of a medical device are not intended to ensure the safe, effective and compliant use of the device. 3.5 me

44、dical device any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by t

45、he manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physio

46、logical process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means Council Directive concerning medical devices (93/42/EEC), Article 1,

47、paragraph 2 (a) 3.6 user any person, legal or natural, for whom the information supplied (see 3.4) is intended 4 Requirements 4.1 General Product information and labelling shall be part of risk management procedures. NOTE 1 Due consideration should be given to the guidance provided in Annex A. NOTE

48、2 Product-related standards may require additional information to be supplied. 4.2 Units, symbols and colours Units used shall be SI units as specified in ISO 1000 or any other legal units. !Symbols and safety-related identification colours shall be explained in the information supplied unless they

49、are taken from harmonised standards.“ DIN EN 1041:2013-12 EN 1041:2008+A1:2013 (E) 7 4.3 Language and country identifiers If the manufacturer decides to identify the language used in the information provided, for example to indicate to users the appropriate language in a multilingual document, this shall be done using the language codes given in ISO 639-1 and/or the plain text of the language (e.g. “English”). If the manufacturer decides to identify the country in the information provided, for example to indicate to users the appropriate customer servic