EN 980-2008中文翻譯.pdf

EUROPEAN STANDARD NORME EUROP ENNE EUROP ISCHE NORM EN 980 May 2008 ICS 01 080 20 11 120 01 Supersedes EN 980 2003 English version Symbols for use in the labelling of medical devices 醫(yī)療器械標(biāo)簽中使用的符號(hào) Symboles utilis s pour l tiquetage des dispostifs m dicaux Symbole zur Kennzeichnung von Medizinprodukten This 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 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 worldwide for CEN national Members and for CENE No EN 980 2008 E BS EN 980 2008 EN 980 2008 E 目錄目錄 前言前言 4 引言引言 5 1 范圍范圍 6 2 規(guī)范性引用文件規(guī)范性引用文件 6 3 術(shù)語(yǔ)和定義術(shù)語(yǔ)和定義 6 4 通用要求通用要求 7 4 1 符號(hào)采用建議符號(hào)采用建議 7 4 2 使用要求使用要求 7 5 已在用的符號(hào)已在用的符號(hào) 8 5 1 總則總則 8 5 2 不可重復(fù)使用 符號(hào) 不可重復(fù)使用 符號(hào) 8 5 3 使用期限 符號(hào) 使用期限 符號(hào) 9 5 4 批次代碼 符號(hào) 批次代碼 符號(hào) 9 5 5 序列編號(hào) 符號(hào) 序列編號(hào) 符號(hào) 10 5 6 制造日期 符號(hào) 制造日期 符號(hào) 10 5 7 無(wú)菌 符號(hào) 無(wú)菌 符號(hào) 11 5 8 包含滅菌方法的 無(wú)菌 符號(hào)包含滅菌方法的 無(wú)菌 符號(hào) 11 5 9 經(jīng)無(wú)菌處理技術(shù)滅菌 符號(hào) 經(jīng)無(wú)菌處理技術(shù)滅菌 符號(hào) 12 5 10 分類(lèi)編號(hào) 符號(hào) 分類(lèi)編號(hào) 符號(hào) 13 5 11 注意 符號(hào) 注意 符號(hào) 13 5 12 制造商 符號(hào) 制造商 符號(hào) 14 5 13 歐盟授權(quán)代表 符號(hào) 歐盟授權(quán)代表 符號(hào) 14 5 14 充分進(jìn)行 符號(hào) 充分進(jìn)行 符號(hào) 15 5 15 僅供體外診斷性能評(píng)估 符號(hào) 僅供體外診斷性能評(píng)估 符號(hào) 15 5 16 體外診斷醫(yī)療器械 符號(hào) 體外診斷醫(yī)療器械 符號(hào) 16 5 17 包含溫度范圍指示的 溫度范圍 符號(hào)包含溫度范圍指示的 溫度范圍 符號(hào) 16 5 18 參考使用說(shuō)明 符號(hào) 參考使用說(shuō)明 符號(hào) 18 5 19 生物風(fēng)險(xiǎn) 符號(hào) 生物風(fēng)險(xiǎn) 符號(hào) 18 5 20 避免日曬 符號(hào) 避免日曬 符號(hào) 18 5 21 保持干燥 符號(hào) 保持干燥 符號(hào) 19 5 22 不可重復(fù)滅菌 符號(hào) 不可重復(fù)滅菌 符號(hào) 19 5 23 非滅菌 符號(hào) 非滅菌 符號(hào) 20 5 24 對(duì)照 符號(hào) 對(duì)照 符號(hào) 20 5 25 陰性對(duì)照 符號(hào) 陰性對(duì)照 符號(hào) 21 5 26 陽(yáng)性對(duì)照 符號(hào) 陽(yáng)性對(duì)照 符號(hào) 21 6 新符號(hào)新符號(hào) 21 6 1 總則總則 21 6 2 含 含有或存有或存在在天然膠乳天然膠乳 符號(hào) 符號(hào) 22 6 3 包 包裝破損切勿裝破損切勿使用 符號(hào)使用 符號(hào) 22 6 4 無(wú)菌液路 符號(hào) 無(wú)菌液路 符號(hào) 22 附錄附錄 A 資料性資料性 本標(biāo)準(zhǔn)所示符號(hào)的應(yīng)用舉例本標(biāo)準(zhǔn)所示符號(hào)的應(yīng)用舉例 24 A 1 使用期限 符號(hào)的應(yīng)用舉例 使用期限 符號(hào)的應(yīng)用舉例 24 A 2 批次代碼 符號(hào)的應(yīng)用舉例 批次代碼 符號(hào)的應(yīng)用舉例 24 A 3 序列編號(hào) 符號(hào)的應(yīng)用舉例 序列編號(hào) 符號(hào)的應(yīng)用舉例 24 A 4 制造日期 符號(hào)的應(yīng)用舉例 制造日期 符號(hào)的應(yīng)用舉例 24 A 5 分類(lèi)編號(hào) 符號(hào)的應(yīng)用舉例 分類(lèi)編號(hào) 符號(hào)的應(yīng)用舉例 25 A 6 制造商 符號(hào)的應(yīng)用舉例 制造商 符號(hào)的應(yīng)用舉例 25 A 7 結(jié)合 制造日期 的 制造商 符號(hào)的應(yīng)用舉例結(jié)合 制造日期 的 制造商 符號(hào)的應(yīng)用舉例 25 A 8 歐盟授權(quán)代表 符號(hào)的應(yīng)用舉例 歐盟授權(quán)代表 符號(hào)的應(yīng)用舉例 25 A 9 充分進(jìn)行 符號(hào)的 充分進(jìn)行 符號(hào)的應(yīng)應(yīng)用用舉例舉例 26 2 BS EN 980 2008 EN 980 2008 E A 10 溫度上限 符號(hào)的應(yīng)用舉例 溫度上限 符號(hào)的應(yīng)用舉例 26 A 11 溫度下限 符號(hào)的應(yīng)用舉例 溫度下限 符號(hào)的應(yīng)用舉例 26 A 12 溫度限值 符號(hào)的應(yīng)用舉例 溫度限值 符號(hào)的應(yīng)用舉例 26 A 13 無(wú)菌液路 符號(hào)的應(yīng)用舉例 無(wú)菌液路 符號(hào)的應(yīng)用舉例 27 附附錄錄 B 資料資料性性 通用通用禁止禁止符號(hào)和無(wú)符號(hào)和無(wú)效效符號(hào)的符號(hào)的應(yīng)應(yīng)用用 28 B 1 通用通用禁止禁止符號(hào)符號(hào) 28 B 2 無(wú)無(wú)效效符號(hào)符號(hào) 28 附錄附錄 ZA 資料性資料性 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第本歐洲標(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 款款 29 附錄附錄 ZB 資料性資料性 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第本歐洲標(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 的條款的條款 29 附錄附錄 ZC 資料性資料性 本歐洲標(biāo)準(zhǔn)中涉及歐盟理事會(huì)第本歐洲標(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 款款 32 參考文獻(xiàn)參考文獻(xiàn) 34 3 BS EN 980 2008 EN 980 2008 E Foreword 前言前言 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 exchange the secretariat of which is held by NEN 本標(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 national 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 identifying 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(lèi)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 essential 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 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 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 西班牙 瑞典 瑞士和英國(guó) 4 BS EN 980 2008 EN 980 2008 E Introduction 引言引言 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 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 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 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 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 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 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 Clause 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 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 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(lèi)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 5 BS EN 980 2008 EN 980 2008 E 1 Scope 范圍范圍 This European Standard specifies symbols for use in the information supplied 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 requirements for information to be supplied with medical 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 2 Normative references 規(guī)范性引用文件規(guī)范性引用文件 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 the manufacturer with in vitro diagnostic reagents for professional use EN375 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 testing EN 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 devices EN 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 use EN 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 in vitro diagnostic instruments for self testing EN 592 用于自我檢測(cè)的體外診斷儀器使用說(shuō)明書(shū) EN 1041 Information supplied by the manufacturer with medical devices EN 1041 制造商需隨醫(yī)療器械提供的信息 EN ISO 15225 Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange ISO 15225 2000 EN ISO 15225 術(shù)語(yǔ) 用于管理資料交流的醫(yī)療器械術(shù)語(yǔ)系統(tǒng)規(guī)范 ISO 15225 2000 ISO 8601 Data elements and interchange formats Information interchange Representation of dates and times ISO 8601 數(shù)據(jù)元和交換格式 信息交換 日期和時(shí)間的表示法 3 Terms and definitions 術(shù)語(yǔ)和定義術(shù)語(yǔ)和定義 For the purposes of this document the following terms and definitions apply 下列術(shù)語(yǔ)和定義適用于本標(biāo)準(zhǔn) 3 1 symbol used in medical device labeling 用于醫(yī)療器械標(biāo)簽的符號(hào)用于醫(yī)療器械標(biāo)簽的符號(hào) object presented on the label and or on the device itself and or associated documentation of a medical device which may utilise symbolic or iconic presentation that communicates characteristic information see 3 4 without relying on knowledge of the language of a particular nation or people by the giver or receiver of the information 標(biāo)簽和 或 器械本身上出現(xiàn)的對(duì)象和 或 醫(yī)療器械相關(guān)文件 可以使用符號(hào)表征或影像表征 并且不依 賴于特定國(guó)家或信息傳達(dá)的授者或受者人群的語(yǔ)言知識(shí)來(lái)傳達(dá)特征信息 見(jiàn)3 4 3 2 symbolic presentation 符號(hào)表征符號(hào)表征 abstract pictorial or graphic representation 抽象圖像或圖示 6 3 3 iconic presentation 影像表征影像表征 pictorial or graphic representation using familiar objects including alphanumeric characters 使用包括字母數(shù)字字符集在內(nèi)的熟悉對(duì)象進(jìn)行圖形或圖解表示 3 4 characteristic information 特征信息特征信息 mental representation of a property or properties of an object or set of objects EN 12264 2005 一個(gè)對(duì)象或一組對(duì)象特性的思想表征 4 General requirements 通用要求通用要求 4 1 Proposal of symbols for adoption 符號(hào)采用建議符號(hào)采用建議 4 1 1 Proposals for symbols for adoption into this European Standard shall be submitted by a body contributing to CEN CLC TC 3 that is one in association liaison or participating in the work of that committee 4 1 1 采用到本歐洲標(biāo)準(zhǔn)的符號(hào)建議應(yīng)由構(gòu)成CEN CLC TC 3技術(shù)委員會(huì)的成員審批 也就是說(shuō) 在該委員 會(huì)的工作中進(jìn)行合作 聯(lián)絡(luò)或參與的組織 4 1 2 Symbols should only be proposed when they represent requirements already defined in a published standard E g the requirements represented by 5 8 are defined in EN 556 1 4 1 2 應(yīng)僅推薦那些已在頒布標(biāo)準(zhǔn)中定義的代表要求的符號(hào) 例如5 8代表的要求已在EN 556 1中定義 4 1 3 Symbols being proposed shall be presented following the dimensional criteria and design principles set out in ISO IEC 80416 Where the presentation is symbolic see 3 2 alphanumeric characters shall not be part of the symbol Alphanumeric characters may be used when appropriate and relevant in an iconic symbol see 3 3 4 1 3 推薦采用的符號(hào)應(yīng)遵循標(biāo)準(zhǔn)ISO IEC 80416中設(shè)定的尺寸標(biāo)準(zhǔn)和設(shè)計(jì)原則來(lái)呈現(xiàn) 符號(hào)表征 見(jiàn)3 2 時(shí) 字母數(shù)字字符集不應(yīng)是符號(hào)的一部分 當(dāng)適于并與影像表征有關(guān)時(shí) 可使用字母數(shù)字字符集 4 1 4 Any symbol proposed for adoption into this European Standard shall be applicable to a range of devices at least comprising one category of the Global Medical Device Nomenclature see EN ISO 15225 4 1 4 任何建議采用到本歐洲標(biāo)準(zhǔn)的符號(hào)應(yīng)適用于比較廣的醫(yī)療器械范圍 其至少包含全球醫(yī)療器械術(shù)語(yǔ)中 的一個(gè)類(lèi)目 見(jiàn)EN ISO 15225 4 1 5 When a symbol is presented for adoption the following details are required 4 1 5 當(dāng)采用的符號(hào)存在 需要考慮到以下細(xì)節(jié) a brief unique title sufficient only to identify the symbol 僅對(duì)于充分識(shí)別該符號(hào)的簡(jiǎn)潔 唯一的標(biāo)題 conditions of use for the symbol and identity of proposed audience 符號(hào)使用條件以及其與推薦讀者的同一性 information on any existing or proposed related symbols 任何現(xiàn)行或建議的相關(guān)符號(hào)的信息 information on any validation or evaluation of the symbol in use 在用符號(hào)的任何確認(rèn)或評(píng)價(jià)信息 a graphic file bitmap JPEG TIF or similar with a print out of the file 帶有文件打印輸出格式的圖形文件 位圖 JPEG TIF或類(lèi)似格式 4 2 Requirements for usage 使用要求使用要求 4 2 1 Symbols contained in Clause 5 may be used without explanation in the information supplied by the manufacturer 4 2 1 第5條中包含的符號(hào)用在制造商提供的信息中可不帶解釋 4 2 2 The meaning of symbols contained in Clause 6 shall be explained in the information supplied by the manufacturer 4 2 2 第6條中所含符號(hào)的意思應(yīng)在制造商提供的信息中進(jìn)行解釋 4 2 3 Symbols shown in 5 2 to 5 26 and 6 2 to 6 4 are used to convey the information described in the headings and notes of those sub clauses 7 4 2 3 5 2到5 26以及6 2到6 4條中所示符號(hào)用于表達(dá)那些子條款的標(biāo)題和注意項(xiàng)所要描述的信息 NOTE 1 Other symbols can be used to convey different information Many other standards specify symbols for particular purposes and or for particular kinds of device The Bibliography lists some of these standards 注1 可用其他符號(hào)傳達(dá)不同的信息 許多其他的標(biāo)準(zhǔn)規(guī)定了特定用途和 或 特種器械符號(hào) 參考文獻(xiàn)中羅列了這些標(biāo)準(zhǔn)的一部 分 NOTE 2 ISO and IEC jointly maintain an on line database of graphical symbols for use on equipment that contains the complete set of graphical symbols included in ISO 7000 IEC 60417 1 and IEC 60417 2 In that database each graphical symbol is identified by a reference number and contains a title in English and French a graphical representation in GIF and vectorized PDF format and some additional data as applicable Various search and navigation facilities allow for easy retrieval of graphical symbols Information on how to access this database is available through the ISO Store the IEC Web Store or by contacting your local national standards body 注2 ISO和IEC組織共同維護(hù)用于設(shè)備的圖解符號(hào)在線數(shù)據(jù)庫(kù) 數(shù)據(jù)庫(kù)包含有ISO 7000 IEC 60417 1和IEC 60417 2中包括的成套 圖解符號(hào) 數(shù)據(jù)庫(kù)中 通過(guò)一個(gè)參考編號(hào)來(lái)識(shí)別每一個(gè)圖解符號(hào) 并且每個(gè)符號(hào)都包含一個(gè)標(biāo)題 以英文和法文 若適用 以GIF 格式和矢量化PDF格式的圖解表示以及某些附加數(shù)據(jù)來(lái)識(shí)別 不同的研究以及導(dǎo)航設(shè)施考慮到圖解符號(hào)的易于修正 關(guān)于如何進(jìn)行數(shù) 據(jù)庫(kù)存取通過(guò)ISO網(wǎng)上商店 IEC網(wǎng)站或聯(lián)系所在國(guó)家標(biāo)準(zhǔn)機(jī)構(gòu)得到該方面信息 4 2 4 Symbols presented in this standard shall be reproduced as illustrated with the exception of 5 5 and 5 10 which may be reproduced with or without the enclosure 4 2 4 除5 5條和5 10條以外 本標(biāo)準(zhǔn)中存在的符號(hào)應(yīng)像所例證的那樣可帶有或不帶有符號(hào)外框進(jìn)行復(fù)制 NOTE Future editions of this standard may remove this exception for 5 5 and 5 10 and an enclosure may be required as defined in ISO 7000 2004 and ISO 15223 1 2007 注 對(duì)5 5和5 10條款 本標(biāo)準(zhǔn)的未來(lái)版本可去除這種例外 并且可能會(huì)像ISO 7000 2004和標(biāo)準(zhǔn)ISO 15223 1 2007中規(guī)定那樣符號(hào) 需要加邊框 4 2 5 All symbols and information intended for visual recognition shall be legible when viewed under an illumination of 215 lx using normal vision corrected if necessary at a distance which takes into account the specifics and size of the individual medical device 4 2 5 所有預(yù)期為視覺(jué)識(shí)別的符號(hào)和信息應(yīng)在215勒克斯 lx 的光照度下以正常視覺(jué)能清楚的辨認(rèn) 若必 要以考慮到個(gè)別醫(yī)療器械的特性和尺寸的距離進(jìn)行修正 NOTE Colours and minimum dimensions are not specified in this standard 注 本標(biāo)準(zhǔn)中沒(méi)有規(guī)定顏色和最小尺寸 4 2 6 Guidance on the appropriate use of the general prohibition symbol is given in Annex B 4 2 6 附錄B中給出了通用禁止符號(hào)的合理使用指南 5 Symbols already in use 已在用的符號(hào)已在用的符號(hào) 5 1 General 總則總則 This Clause contains symbols that are already in use and are deemed to be suitable without need for further explanation 本條主要包含那些已經(jīng)在用的 并被認(rèn)為不需要進(jìn)一步解釋的合適的符號(hào) NOTE Symbols used with medical devices for use by other than healthcare professionals can require additional explanations 注 非醫(yī)療專業(yè)人員使用醫(yī)療器械應(yīng)用的符號(hào)可能需要補(bǔ)充解釋 Annexes ZA ZB and ZC can be used to determine the symbols that address essential requirements of Council Directives 93 42 EEC 90 385 EEC and 98 79 EC respectively 附錄ZA ZB和ZC能用于規(guī)定符號(hào)滿足歐盟理事會(huì)第 93 42 EEC 90 385 EEC和98 79 EC號(hào)等相關(guān)指令對(duì) 醫(yī)療器械的基本要求 5 2 Symbol for DO NOT REUSE 不可重復(fù)使用 符號(hào) 不可重復(fù)使用 符號(hào) NOTE 1 Synonyms for Do not reuse are single use Use only once 注1 不可重復(fù)使用 符號(hào)就是 一次性使用 僅供一次使用 的意思 NOTE 2 This symbol corresponds to that given in ISO 7000 1051 and to symbol number 5 2 in ISO 15223 1 2007 注2 該符號(hào)與ISO 7000 1051標(biāo)準(zhǔn)中給出的相一致 也對(duì)應(yīng)于ISO 15223 1 2007標(biāo)準(zhǔn)中編號(hào)5 2中的符號(hào) 5 3 Symbol for USE BY 使用期限 符號(hào) 使用期限 符號(hào) This symbol shall be accompanied by a date to indicate that the device should not be used after the end of the year month or day shown The date shall be expressed as given in ISO 8601 as four digits for the year and where appropriate two digits for the month and two digits for the day The date could be a year year and month or year month and day as required by the relevant Directive The date shall be located adjacent to the symbol see A 1 該符號(hào)應(yīng)附有日期來(lái)指示器械不應(yīng)在所示年 月或日之后使用 應(yīng)按ISO 8601規(guī)定標(biāo)注日期 其中年用四位 數(shù)字表示 在適當(dāng)情況下 可用兩位數(shù)字表示月份 兩位表示某天 日期可以是相關(guān)法令要求的年 年和 月 或者年月日格式 日期應(yīng)位于緊靠符號(hào)的位置 見(jiàn)A 1 NOTE 1 For example