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EN 1041-2008 BRITISH STANDARD BS EN 1041:2008 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Information supplied by the manufacturer of medical devices ICS 01.110; 11.040.01; 11.120.01 BS EN 1041:2008 National foreword This British Standard is ...

EN 1041-2008
BRITISH STANDARD BS EN 1041:2008 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Information supplied by the manufacturer of medical devices ICS 01.110; 11.040.01; 11.120.01 BS EN 1041:2008 National foreword This British Standard is the UK implementation of EN 1041:2008. It supersedes BS EN 1041:1998, which will be withdrawn on 3 August 2011. The UK participation in its preparation was entrusted to Technical Committee CH/210/3, General terminology and symbols. A list of organizations 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. 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 August 2008 © BSI 2008 ISBN 978 0 580 54661 7 Amendments/corrigenda issued since publication Date Comments BS EN 1041:2008 EUROPEAN STANDARD EN 1041 NORME EUROPÉENNE EUROPÄISCHE NORM August 2008 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:1998 English version Information supplied by the manufacturer of medical devices Informations fournies par le fabricant de dispositifs Bereitstellung von Informationen durch den Hersteller von médicaux Medizinprodukten This European Standard was approved by CEN on 4 July 2008. CEN andCENELEC 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 bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or 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/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels © 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 1041:2008 E worldwide for CEN national Members and for CENELEC Members. 2 BS EN 1041:2008 EN 1041:2008 (E) 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 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 5.2 Specific requirements 8 5.2.1 Applicability 8 5.2.2 Accessibility 8 5.2.3 Legibility 8 5.2.4 Availability 8 5.2.5 Security 8 5.2.6 Changes to information provided 8 6 Documentation 8 Annex A (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended 9 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) 9 A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC) 15 Annex B (informative) Guidance on alternative labelling for instructions for use (IFU) 19 B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) 20 B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC) 21 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC 22 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC 23 Bibliography 24 BS EN 1041:2008 EN 1041:2008 (E) 3 Foreword This document (EN 1041:2008) 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 EN 1041:2008 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2009 and conflicting national standards shall be withdrawn at the latest by August 2011. This document supersedes EN 1041:1998. 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 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 parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 1041:2008 EN 1041:2008 (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) (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 device 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 freely 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 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 provision 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 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. BS EN 1041:2008 EN 1041:2008 (E) 5 1 Scope This standard 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 follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be 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, this standard does not provide derogation from these requirements for that country. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 980, Symbols for use in the labelling of medical devices EN ISO 3166-1, 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 of 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 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 NOTE The defined amount of material or number of devices will normally be associated with a unique statement of conformity to a defined quality specification. 3.2 batch code; lot number; batch number; lot code unique identifier associated with a single batch or lot (see 3.1) BS EN 1041:2008 EN 1041:2008 (E) 3.3 6 alternative labelling any form of electronically accessible 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 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 medical 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 the manufacturer to be used for human beings for the purpose of: � diagnosis, prevention, monitoring, treatment or alleviation of disease;
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