EN980中文翻译医疗器械用符号

1、european standard norme europÉenne europÄische normen 980may 2008ics 01.080.20; 11.120.01supersedes en 980:2003english versionsymbols for use in the labelling of medical devices医疗器械标签中使用的符号symboles utilisés pour l'étiquetage des dispostifs médicauxsymbole zur kennzeichnu

2、ng von medizinproduktenthis european standard was approved by cen on 18 april 2008.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-da

3、te 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 translati

4、on 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

5、, 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 andunited kingdom.cen management centre:cenel

6、ec central secretariat:rue de stassart, 36 b-1050 brusselsrue de stassart, 35 b-1050 brussels© 2008 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 980:2008 ebs en 980:2008en 980:2008 (e)目录前言. 4引

7、言 . 51范围 . 62规范性引用文件 . 63术语和定义 . 64通用要求. 74.1符号采用建议. 74.2使用要求. 75已在用的符号 . 85.1总则. 85.2“不可重复使用”符号 . 85.3“使用期限”符号 . 95.4“批次代码”符号. 95.5“序列编号”符号. 105.6“制造日期”符号. 105.7“无菌”符号 . 115.8包含灭菌方法的“无菌”符号 . 115.9“经无菌处理技术灭菌”符号. 125.10“分类编号”符号 . 135.11“注意”符号 . 135.12“制造商”符号 . 145.13“欧盟授权代表”符号. 145.14“充分进行”符号. 155.15

8、“仅供体外诊断性能评估”符号. 155.16“体外诊断医疗器械”符号. 165.17包含温度范围指示的“温度范围”符号. 165.18“参考使用说明”符号. 185.19“生物风险”符号 . 185.20“避免日晒”符号 . 185.21“保持干燥”符号. 195.22“不可重复灭菌”符号. 195.23“非灭菌”符号 . 205.24“对照”符号. 205.25“阴性对照”符号. 215.26“阳性对照”符号 . 216新符号 . 216.1总则. 216.2“含有或存在天然胶乳”符号 . 226.3“包装破损切勿使用”符号. 226.4“无菌液路”符号. 22附录 a (资料性) 本标准所

9、示符号的应用举例 . 24a.1“使用期限”符号的应用举例. 24a.2“批次代码”符号的应用举例 . 24a.3“序列编号”符号的应用举例. 24a.4“制造日期”符号的应用举例 . 24a.5“分类编号”符号的应用举例. 25a.6“制造商”符号的应用举例 . 25a.7结合“制造日期”的“制造商”符号的应用举例. 25a.8“欧盟授权代表”符号的应用举例. 25a.9“充分进行”符号的应用举例 . 262bs en 980:2008en 980:2008 (e)a.10“温度上限”符号的应用举例 . 26a.11“温度下限”符号的应用举例. 26a.12“温度限值”符号的应用举例. 26

10、a.13“无菌液路”符号的应用举例 . 27附录 b (资料性) 通用禁止符号和无效符号的应用. 28b.1通用禁止符号 . 28b.2无效符号 . 28附录 za (资料性) 本欧洲标准中涉及欧盟理事会第 93/42/eec 号指令对医疗器械的基本要求和其他规定的条款. 29附录 zb (资料性) 本欧洲标准中涉及欧盟理事会第 90/385/eec 号指令对有源植入性医疗器械的基本要求和其他规定的条款. 29附录 zc (资料性) 本欧洲标准中涉及欧盟理事会第 98/79/ec 号指令对体外诊断医疗器械的基本要求和其他规定的条款. 32参考文献 . 343bs en 980:2008en 9

11、80:2008 (e)foreword 前言this document (en 980:2008) has been prepared by technical committee cen/clc/tc 3 "quality management and corresponding general aspects for medical devices" (former cen/tc 257 “symbols and information provided with medical devices and nomenclature for regulatory data

12、exchange”), the secretariat of which is held by nen.本标准（en 980:2008）由技术委员会cen/clc/tc 3“医疗器械质量管理和相应的一般情况”（前身是cen/tc 257“医疗器械提供的符号和信息以及数据交流管理术语”）编制，该技术委员会的秘书处由nen担任。this european standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at

13、 the latest by november 2008, and conflicting national standards shall be withdrawn at the latest by may 2010.本欧洲标准不迟于2008年11月，通过正式发布同文或背书取得成员国的国家标准地位，与此相抵触的国家标准应不迟于2010年5月废除。attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. cen and

14、/or cenelec shall not be held responsible for identifying any or all such patent rights.要注意到本标准中某些要素可能是有专利权的对象的可能性。cen（和/或cenelec）组织不应对任何或所有此类专利权的鉴别负责。this document supersedes en 980:2003.本标准取代en 980:2003。this document has been prepared under a mandate given to cen by the european commission and the

15、 european free trade association, and supports essential requirements of ec directive(s).本欧洲标准由欧盟委员会以及欧洲自由贸易联盟授权给cen（欧洲标准化委员会）和cenelec（欧洲电工标准化委员会）编制，支持欧共体理事会指令的基本要求。for relationship with ec directive(s), see informative annex za, zb, and zc, which are an integral part of this document.有关该标准与欧共体指令的关系

16、，请参阅本标准的组成部分资料性附录za、zb以及zc。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

17、, iceland, ireland, italy, latvia, lithuania, luxembourg, malta, netherlands, norway, poland, portugal, romania, slovakia, slovenia, spain, sweden, switzerland and the united kingdom.根据欧洲标准化委员会/欧洲电工标准化委员会（cen/cenelec）的内部规章规定，下列国家的国家标准机构必须执行本欧洲标准：奥地利、比利时、保加利亚、塞浦路斯、捷克共和国、丹麦、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、冰岛、爱尔兰

18、、意大利、拉脱维亚、立陶宛、卢森堡、马耳他、荷兰、挪威、波兰、葡萄牙、罗马尼亚、斯洛伐克、斯洛文尼亚、西班牙、瑞典、瑞士和英国。4bs en 980:2008en 980:2008 (e)introduction 引言this european standard has been prepared to give expression to the legislative preference within the european union for the use of symbols in medical device labelling, thereby reducing the ne

19、ed for multiple translations of words into national languages. it is also intended to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information. it has been prepared to align the presentation of information required by all european d

20、irectives on medical devices.本标准的编制已经表示出医疗器械标签中所用符号在欧盟范围内的立法优先权，因此减少了转化为成员国民族语言时多语种的文本翻译。本标准也预期要尽可能简化标签并防止表达相同信息的不同符号的分别发展。本标准的编制校正了对所有欧洲指令要求的医疗器械信息的表达。the meaning of some of these symbols is self-evident. some are already in widespread use and familiar to healthcare professionals. the meaning of ot

21、hers will become clear with use or when viewed in the context of the device itself. symbols used with medical devices for use by other than healthcare professionals can require additional explanations. in this respect, attention is drawn to the fact that risk management, e.g. the use of en iso 14971

22、, is an integral element in medical device design and manufacturing. the use of appropriate symbols can, therefore, be an important element in risk reduction, which is a key part of risk management and is also specifically referred to in the relevant medical device directives. symbols should only be

23、 used without explanation when risk assessment by the manufacturer indicates that it is appropriate.某些符号的含义不言而喻。还有一些已被广泛的应用并被医疗保健专业人员所熟悉。其他一些符号含义会在使用或查看器械自身情况下而变得清晰。供给非医疗保健专业人员使用的医疗器械所用符号可能会要求附加说明。在这方面，要注意到风险管理如en iso 14971的应用在医疗器械设计和制造过程中是一个主要元素这个事实。因此，符号的恰当应用是降低风险的一个重要因素，降低风险是风险管理的关键部分并且也在相关的医疗器械指

24、令中特别提及到。不带说明的符号应只在制造商所做的风险评估表明是合适的情况下应用。the symbols in clause 5 of this european standard have been in general use for some time and users have some degree of familiarity with them. additional symbols are now being introduced in clause 6 which may be new or unfamiliar to users. as a precaution, clau

25、se 6 requires that the meaning of these new symbols be explained in the information supplied by the manufacturer. this is without prejudice to the harmonization of this european standard and the symbols therein.本欧洲标准第5条中的符号已经通用了一段时间并且使用者已经对他们有了一定程度的熟悉。第6条现在引入了一些新增符号，这些符号对使用者来说可能是全新或不熟悉的。需要注意的是，第6条要求

26、制造商提供的信息中要对这些新符号的含义加以说明。这一点并不对本欧洲标准及其中的符号的协调性构成影响。it is not always possible to develop symbols for all information presented with the device. not all symbols are appropriate for all types of medical devices. the validity of information conveyed by a symbol can be adversely affected by subsequent eve

27、nts e.g. damage to a package can affect the sterility of a device.因为要使医疗器械的所有信息都有图例表示并不是总是可能的。并非所有的符号对任何类型的医疗器械都适合。符号所传递信息的有效性会收到后续时间的负面影响，比如包装损坏就会影响器械的“无菌性”。annex a provides examples of how some of the symbols can be used. these are illustrative only and do not represent the only ways in which the

28、requirements of this standard can be met.附录a提供了部分符号如何使用的举例。这些例子仅是对用法的举例说明，并不代表是满足标准要求的唯一方式。annex b provides information about the use of the general prohibition symbol.附录b提供了关于通用禁止符号的用法信息。5bs en 980:2008en 980:2008 (e)1scope 范围this european standard specifies symbols for use in the information suppl

29、ied by the manufacturer with medical devices. the requirements of this european standard are not intended to apply to symbols specified in other standards. however, every effort should be made to prevent the specifying of different symbols with the same meaning. this standard does not specify the re

30、quirements for information to be supplied with medical devices, which are addressed by en 375, en 376, en 591, en 592 and en 1041.本欧洲标准规定了医疗器械制造商提供信息时使用的符号。其要求并不预期适用于在其他标准中规定了的符号。尽管如此，应竭尽尽力阻止出现相同的意思规定了不同的符号的情况。本标准没有对提供的医疗器械信息要求进行规定，但是其已在en 375、en 376、en 591和en 1041中做出了要求。2normative references 规范性引用文

31、件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.下列参考文件是该文件适用的重要组成部分。凡是注明日期的引用文件，只采用被引版本。凡是不注日期的引用

32、文件，采用其最新版本（包括全部修订）。en 375, information supplied by the manufacturer with in vitro diagnostic reagents for professional useen375 制造商提供的专业用体外诊断试剂信息en 376, information supplied by the manufacturer with in vitro diagnostic reagents for self-testingen 376 制造商提供的用于自我检测体外诊断试剂信息en 556-1:2001, sterilization

33、of medical devices - requirements for medical devices to be designated "sterile" part 1: requirements for terminally sterilized medical devicesen 556-1：2001 医疗器械灭菌-无菌医疗器械要求-第1部分：最终灭菌医疗器械的要求en 591, instructions for use for in vitro diagnostic instruments for professional useen 591 专业用体外诊断仪器的使用说明书en 592, instructions for