Information supplied
巨人杀手杰克
by the manufacturer of
medical devices
医疗器械厂商提供的信息
I C S 01.110; 11.040.01; 11.120.01
B R I T I S H S T A N D A R D B S E N
1041:2008
N O COPYING W I T H O U T BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT L A W
B S E N 1041:2008
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National foreword
国家前言
This British Standard is the U K implementation of E N 1041:2008. It
superdes BS E N1041:1998, which will be withdrawn on 3 August 2011.
此英国标准是英国执行的EN1041：2008，取代了英国标准EN 1041：1998，将于
2011年8月3日被孤立。
The U K participation in its preparation was entrusted to Technical
Committee CH/210/3, General terminology and symbols.
A list of organizations reprented on this committee can be obtained on request
to its cretary.
This publication does not purport to include all the necessary provisions of
a contract. Urs are responsible for its correct application.
Compliance with a British Standard cannot confer immunity from
legal obligations.
英国参与此制定是委托了技术委员会CH/210/3，常规术语和符号。
包括此委员会代表的组织列表，如有需求可询问委员会秘书。
此出版不包括协议中所有必要的规定。使用者负责正确的应用。assistance
mnemosyne依照英国标准不会协商法律规定的免疫性。
This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2008 此英国标准在标准准则和委员会
的授权下于2008年8月31日出版© BSI 2008
hppc
I S B N 978 0 580 54661 7 Amendments/corrigenda issued since publication
出版时颁布的修改
Date Comments
EUROPEAN STANDARD
EN 1041 NORME EUROP ÉENNE
EUROP ÄISCHE NORM
August 2008 ICS 01.110; 11.040.01; 11.120.01 Superdes EN 1041:1998
English version
Information supplied by the manufacturer of medical devices
医疗器械厂商提供的信息
Informations fournies par le fabricant de dispositifs
Bereitstellung von Informationen durch den Hersteller von m édicaux 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 Brusls
© 2008 CEN/CENELEC All rights of exploitation in any form
and by any means rerved
BS EN 1041:2008
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)listeningtomusic
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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)
阴天的英文Annex B (informative) Guidance on alternative labelling for instructions for u (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 Esntial Requirements of EU Directive 93/42/EC (22)
Annex ZB (informative) Relationship between this European Standard and the Esntial Requirements of EU Directive 90/385/EC (23)
Bibliography (24)
2
BS EN 1041:2008
EN 1041:2008 (E)
Foreword 前言
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 cretariat of which is held by NEN.
此文件由技术委员会CEN/CLC TC 3“医疗器械质量管理和相应常规方面”制定，秘书处由NEN担任。
This European Standard EN 1041:2008 shall be given the status of a national standard, either by publication of an identical text or by endorment, at the latest by February 2009 and conflicting national standards shall be withdrawn at the latest by August 2011.
此欧洲标准EN 1041：2008表示了国际标准的状态，最晚在2009年2月前通过出版同样的内容或签注，不一致的国际标准将最晚在2011年8月前被取消。
This document superdes EN 1041:1998.
此文件代替了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 esntial requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B.
此文件根据欧洲委员会和欧洲自由贸易组织提供的CEN收到的要求进行制定，向EU指示93/42/EEC和90/385/EEC提供了必要的需求，如补偿，除了3.3和附件B。
Annex A provides practical guidance about the implementation of the esntial requirements of the applicable Directives.
附件A提供了操作指南，关于可适用指示的必要需求的执行。黑龙江雅思培训
For relationship with EU Directives, e informative Annexes ZA and ZB, which are integral parts of this document. 为了EU 指示关系，请见信息的附件ZA和ZB，是此文件的主要部分。
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.
根据CEN/CENELEC国际规定，以下国家的国际标准组织必须执行此欧洲标准：
3
