EN980-2008中文翻譯

1、european standard norme europenne europische normen 980may 2008ics 01.080.20; 11.120.01supersedes en 980:2003english versionsymbols for use in the labelling of medical devices醫(yī)療器械標(biāo)簽中使用的符號(hào)symboles utiliss pour ltiquetage des dispostifs mdicauxsymbole zur kennzeichnung von medizinproduktenthis europea

2、n 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-date lists and bibliographical refere

3、nces 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 ce

4、n 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,

5、 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:cenelec central secretariat:rue de stass

6、art, 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)目錄前言. 4引言 . 51范圍 . 62規(guī)范性引用文件 . 63術(shù)語(yǔ)和定義 . 64通用要求.

7、74.1符號(hào)采用建議. 74.2使用要求. 75已在用的符號(hào) . 85.1總則. 85.2“不可重復(fù)使用”符號(hào) . 85.3“使用期限”符號(hào) . 95.4“批次代碼”符號(hào). 95.5“序列編號(hào)”符號(hào). 105.6“制造日期”符號(hào). 105.7“無(wú)菌”符號(hào) . 115.8包含滅菌方法的“無(wú)菌”符號(hào) . 115.9“經(jīng)無(wú)菌處理技術(shù)滅菌”符號(hào). 125.10“分類編號(hào)”符號(hào) . 135.11“注意”符號(hào) . 135.12“制造商”符號(hào) . 145.13“歐盟授權(quán)代表”符號(hào). 145.14“充分進(jìn)行”符號(hào). 155.15“僅供體外診斷性能評(píng)估”符號(hào). 155.16“體外診斷醫(yī)療器械”符號(hào). 165.1

8、7包含溫度范圍指示的“溫度范圍”符號(hào). 165.18“參考使用說(shuō)明”符號(hào). 185.19“生物風(fēng)險(xiǎn)”符號(hào) . 185.20“避免日曬”符號(hào) . 185.21“保持干燥”符號(hào). 195.22“不可重復(fù)滅菌”符號(hào). 195.23“非滅菌”符號(hào) . 205.24“對(duì)照”符號(hào). 205.25“陰性對(duì)照”符號(hào). 215.26“陽(yáng)性對(duì)照”符號(hào) . 216新符號(hào) . 216.1總則. 216.2“含有或存在天然膠乳”符號(hào) . 226.3“包裝破損切勿使用”符號(hào). 226.4“無(wú)菌液路”符號(hào). 22附錄 a (資料性) 本標(biāo)準(zhǔn)所示符號(hào)的應(yīng)用舉例 . 24a.1“使用期限”符號(hào)的應(yīng)用舉例. 24a.2“批次代碼

9、”符號(hào)的應(yīng)用舉例 . 24a.3“序列編號(hào)”符號(hào)的應(yīng)用舉例. 24a.4“制造日期”符號(hào)的應(yīng)用舉例 . 24a.5“分類編號(hào)”符號(hào)的應(yīng)用舉例. 25a.6“制造商”符號(hào)的應(yīng)用舉例 . 25a.7結(jié)合“制造日期”的“制造商”符號(hào)的應(yīng)用舉例. 25a.8“歐盟授權(quán)代表”符號(hào)的應(yīng)用舉例. 25a.9“充分進(jìn)行”符號(hào)的應(yīng)用舉例 . 262bs en 980:2008en 980:2008 (e)a.10“溫度上限”符號(hào)的應(yīng)用舉例 . 26a.11“溫度下限”符號(hào)的應(yīng)用舉例. 26a.12“溫度限值”符號(hào)的應(yīng)用舉例. 26a.13“無(wú)菌液路”符號(hào)的應(yīng)用舉例 . 27附錄 b (資料性) 通用禁止符號(hào)和無(wú)

10、效符號(hào)的應(yīng)用. 28b.1通用禁止符號(hào) . 28b.2無(wú)效符號(hào) . 28附錄 za (資料性) 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第 93/42/eec 號(hào)指令對(duì)醫(yī)療器械的基本要求和其他規(guī)定的條款. 29附錄 zb (資料性) 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第 90/385/eec 號(hào)指令對(duì)有源植入性醫(yī)療器械的基本要求和其他規(guī)定的條款. 29附錄 zc (資料性) 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第 98/79/ec 號(hào)指令對(duì)體外診斷醫(yī)療器械的基本要求和其他規(guī)定的條款. 32參考文獻(xiàn) . 343bs en 980:2008en 980:2008 (e)foreword 前言this document (en 9

11、80:2008) 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 exchange”), the secretariat of which is held by nen.本

12、標(biāo)準(zhǔn)（en 980:2008）由技術(shù)委員會(huì)cen/clc/tc 3“醫(yī)療器械質(zhì)量管理和相應(yīng)的一般情況”（前身是cen/tc 257“醫(yī)療器械提供的符號(hào)和信息以及數(shù)據(jù)交流管理術(shù)語(yǔ)”）編制，該技術(shù)委員會(huì)的秘書(shū)處由nen擔(dān)任。this european standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by november 2008, and conflicting nationa

13、l standards shall be withdrawn at the latest by may 2010.本歐洲標(biāo)準(zhǔn)不遲于2008年11月，通過(guò)正式發(fā)布同文或背書(shū)取得成員國(guó)的國(guó)家標(biāo)準(zhǔn)地位，與此相抵觸的國(guó)家標(biāo)準(zhǔn)應(yīng)不遲于2010年5月廢除。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 identif

14、ying any or all such patent rights.要注意到本標(biāo)準(zhǔn)中某些要素可能是有專利權(quán)的對(duì)象的可能性。cen（和/或cenelec）組織不應(yīng)對(duì)任何或所有此類專利權(quán)的鑒別負(fù)責(zé)。this document supersedes en 980:2003.本標(biāo)準(zhǔn)取代en 980:2003。this document has been prepared under a mandate given to cen by the european commission and the european free trade association, and supports essent

15、ial requirements of ec directive(s).本歐洲標(biāo)準(zhǔn)由歐盟委員會(huì)以及歐洲自由貿(mào)易聯(lián)盟授權(quán)給cen（歐洲標(biāo)準(zhǔn)化委員會(huì)）和cenelec（歐洲電工標(biāo)準(zhǔn)化委員會(huì)）編制，支持歐共體理事會(huì)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.有關(guān)該標(biāo)準(zhǔn)與歐共體指令的關(guān)系，請(qǐng)參閱本標(biāo)準(zhǔn)的組成部分資料性附錄za、zb以及zc。according to the cen/cenel

16、ec 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, luxembo

17、urg, malta, netherlands, norway, poland, portugal, romania, slovakia, slovenia, spain, sweden, switzerland and the united kingdom.根據(jù)歐洲標(biāo)準(zhǔn)化委員會(huì)/歐洲電工標(biāo)準(zhǔn)化委員會(huì)（cen/cenelec）的內(nèi)部規(guī)章規(guī)定，下列國(guó)家的國(guó)家標(biāo)準(zhǔn)機(jī)構(gòu)必須執(zhí)行本歐洲標(biāo)準(zhǔn)：奧地利、比利時(shí)、保加利亞、塞浦路斯、捷克共和國(guó)、丹麥、愛(ài)沙尼亞、芬蘭、法國(guó)、德國(guó)、希臘、匈牙利、冰島、愛(ài)爾蘭、意大利、拉脫維亞、立陶宛、盧森堡、馬耳他、荷蘭、挪威、波蘭、葡萄牙、羅馬尼亞、斯洛伐克、斯洛文尼亞、西班

18、牙、瑞典、瑞士和英國(guó)。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 need for multiple translations of words into national l

19、anguages. 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 directives on medical devices.本標(biāo)準(zhǔn)的編制已經(jīng)表示出醫(yī)療器械標(biāo)簽中所用符號(hào)在歐

20、盟范圍內(nèi)的立法優(yōu)先權(quán)，因此減少了轉(zhuǎn)化為成員國(guó)民族語(yǔ)言時(shí)多語(yǔ)種的文本翻譯。本標(biāo)準(zhǔn)也預(yù)期要盡可能簡(jiǎn)化標(biāo)簽并防止表達(dá)相同信息的不同符號(hào)的分別發(fā)展。本標(biāo)準(zhǔn)的編制校正了對(duì)所有歐洲指令要求的醫(yī)療器械信息的表達(dá)。the meaning of some of these symbols is self-evident. some are already in widespread use and familiar to healthcare professionals. the meaning of others will become clear with use or when viewed in the

21、 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, is an integral element in medical device design and

22、 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 used without explanation when risk assessment by the

23、 manufacturer indicates that it is appropriate.某些符號(hào)的含義不言而喻。還有一些已被廣泛的應(yīng)用并被醫(yī)療保健專業(yè)人員所熟悉。其他一些符號(hào)含義會(huì)在使用或查看器械自身情況下而變得清晰。供給非醫(yī)療保健專業(yè)人員使用的醫(yī)療器械所用符號(hào)可能會(huì)要求附加說(shuō)明。在這方面，要注意到風(fēng)險(xiǎn)管理如en iso 14971的應(yīng)用在醫(yī)療器械設(shè)計(jì)和制造過(guò)程中是一個(gè)主要元素這個(gè)事實(shí)。因此，符號(hào)的恰當(dāng)應(yīng)用是降低風(fēng)險(xiǎn)的一個(gè)重要因素，降低風(fēng)險(xiǎn)是風(fēng)險(xiǎn)管理的關(guān)鍵部分并且也在相關(guān)的醫(yī)療器械指令中特別提及到。不帶說(shuō)明的符號(hào)應(yīng)只在制造商所做的風(fēng)險(xiǎn)評(píng)估表明是合適的情況下應(yīng)用。the symbols i

24、n 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, clause 6 requires that the meaning of these new symbols b

25、e explained in the information supplied by the manufacturer. this is without prejudice to the harmonization of this european standard and the symbols therein.本歐洲標(biāo)準(zhǔn)第5條中的符號(hào)已經(jīng)通用了一段時(shí)間并且使用者已經(jīng)對(duì)他們有了一定程度的熟悉。第6條現(xiàn)在引入了一些新增符號(hào)，這些符號(hào)對(duì)使用者來(lái)說(shuō)可能是全新或不熟悉的。需要注意的是，第6條要求制造商提供的信息中要對(duì)這些新符號(hào)的含義加以說(shuō)明。這一點(diǎn)并不對(duì)本歐洲標(biāo)準(zhǔn)及其中的符號(hào)的協(xié)調(diào)性構(gòu)成影響。it

26、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 events e.g. damage to a package can affect the sterility

27、 of a device.因?yàn)橐贯t(yī)療器械的所有信息都有圖例表示并不是總是可能的。并非所有的符號(hào)對(duì)任何類型的醫(yī)療器械都適合。符號(hào)所傳遞信息的有效性會(huì)收到后續(xù)時(shí)間的負(fù)面影響，比如包裝損壞就會(huì)影響器械的“無(wú)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 requirements of this standard can be met.附錄a提供了部分符號(hào)如何

28、使用的舉例。這些例子僅是對(duì)用法的舉例說(shuō)明，并不代表是滿足標(biāo)準(zhǔn)要求的唯一方式。annex b provides information about the use of the general prohibition symbol.附錄b提供了關(guān)于通用禁止符號(hào)的用法信息。5bs en 980:2008en 980:2008 (e)1scope 范圍this european standard specifies symbols for use in the information supplied by the manufacturer with medical devices. the req

29、uirements 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 requirements for information to be supplied with medica

30、l devices, which are addressed by en 375, en 376, en 591, en 592 and en 1041.本歐洲標(biāo)準(zhǔn)規(guī)定了醫(yī)療器械制造商提供信息時(shí)使用的符號(hào)。其要求并不預(yù)期適用于在其他標(biāo)準(zhǔn)中規(guī)定了的符號(hào)。盡管如此，應(yīng)竭盡盡力阻止出現(xiàn)相同的意思規(guī)定了不同的符號(hào)的情況。本標(biāo)準(zhǔn)沒(méi)有對(duì)提供的醫(yī)療器械信息要求進(jìn)行規(guī)定，但是其已在en 375、en 376、en 591和en 1041中做出了要求。2normative references 規(guī)范性引用文件the following referenced documents are indispensable

31、 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.下列參考文件是該文件適用的重要組成部分。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文件，采用其最新版本（包括全部修訂）。en 375, information supplied by th

32、e manufacturer with in vitro diagnostic reagents for professional useen375 制造商提供的專業(yè)用體外診斷試劑信息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檢測(cè)體外診斷試劑信息en 556-1:2001, sterilization of medical devices - requirements for medical devices to be designated sterile part 1: requirements for terminally sterilized medical devicesen 556-1：2001 醫(yī)療器械滅菌-無(wú)菌醫(yī)療器械要求-第1部分：最終滅菌醫(yī)療器械的要求en 591, instructions for use for in vitro diagnostic instruments for professional useen 591 專業(yè)用體外診斷儀器的使用說(shuō)明書(shū)en 592, instructions for use for