【正文】 符號。這些 例 子 僅 是 對用法的舉例說明，并 不代表是滿足標準要求的唯一方式 。符號所傳遞信 息的有效性 會收到后續(xù)時間的負面影響，比如包裝損壞就會影響器械的“無菌性”。 It is not always possible to develop symbols for all informati on presented with the device. Not all symbols are appropri ate for all types of medic al devices. The validity of informati on convey ed by a symbol can be adversel y affected by subsequent events . damage to a package can affect the sterility of a device. 因為要使醫(yī)療器械的所有信息都有圖例 表示 并不是總是可能的 。需要注意的是，第 6條要求制造商提供的信息中要對這些新符號的含義加以說明。 The s ymbols i n Cl aus e 5 of this European S tandard hav e been i n general us e for s om e ti me and us ers have s ome degree of famili arity with them. A dditi onal s ymbols are now bei ng i ntroduc ed i n Cl aus e 6 whi c h may be new or unfamiliar to us ers. A s a prec auti on, Cl aus e 6 requires that the me ani ng of thes e new s ymbols be ex pl ai ned i n the informati on s uppli ed by the manufac turer. Thi s is wi thout prej udic e to the harmoniz ation of thi s European Standard and the symbol s therein. 本歐洲標準第 5條中的符號已經(jīng)通用了一段時間并且使用者已經(jīng)對他們 有 了 一定程度的熟悉。 因此，符號的恰當應用 是 降低風險的 一個重要因素， 降低風險是風險管理的關鍵部分 并且也在相關的醫(yī)療器械指令中特別提及到。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 可能會 要求附加說明。 還有一些已被廣泛的應用并被醫(yī)療保健專業(yè)人員所熟悉。本標準的編制校正了對所有歐洲指令要求的醫(yī)療器械 信息的表達。 4 BS EN 980:2020 EN 980:2020 (E) Introduction 引言 This European Standard has been prepared to give expression to the legislative preferenc e 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 wherev er possible and to prevent separate developm ent of different symbols to convey the same informati on. It has been prepared to align the presentati on of information required by all Europea n Directives on medical devices. 本標準 的編制 已經(jīng) 表 示 出醫(yī)療器械標簽中所用符號在歐盟范圍內的立法優(yōu)先權，因此 減少了轉化為成員國 民族 語言時多語種的文本翻譯。 For relations hi p with EC Directiv e(s ), see informati v e Annex ZA, ZB, and ZC, which are an integral part of this docum ent. 有關該標準與歐共體指令的關系，請參閱本標準的組成部分 —— 資料性附錄 ZA、 ZB以及 ZC。 This docum ent supersedes EN 980:2020. 本標準 取代 EN 980:2020。 Attenti on is drawn to the possibili ty that some of the elements of this docum ent may be the subject of patent rights. CEN [and/or CENE LE C] shall not be held responsi bl e for identi fyi ng any or all such patent rights . 要注意到本標準中某些 要 素可能是 有 專利權 的對象 的可能性。 2020 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC . No. EN 980:2020 E BS EN 980:2020 EN 980:2020 (E) 目錄 前言 ..................................................................................................... ......................................................................... 4 引言 ................................................................................................................................................................ ............. 5 1 范圍 ................................................................................................................................................................ 6 2 規(guī) 范性引用文件 ....................................................................................................... ....................................... 6 3 術 語 和定義 .................................................................................................................................................... 6 4 通 用要求 ..................................................................................................... ..................................................... 7 符號采用建議 .......................................................................................... ........................................................ 7 使 用要求 ............................................. ................................................... ......................................................... 7 5 已 在 用的符號 ..................................................................................... ............................................................ 8 總則 ................................................................................................... ............................................................. 8 “ 不可重復 使用 ” 符號 .................................................................................................................................. 8 “ 使用期限” 符號 ......................................................................... ................................................................ 9 “ 批次代碼” 符號 ....................................................................... ................................................................... 9 “ 序列編號” 符號 ....................................................................... ................................................................... 10 “ 制造日期” 符號 ..................................................................................................................................... ..... 10 “ 無菌 ” 符號 ................................................................................................................................................ 11 包含滅菌 方法的 “無菌” 符號 ....................................................................................................................... 11 “ 經(jīng)無菌處理技術滅菌” 符號 .................................................................................................................. ....... 12 “ 分類 編號” 符號 ........................................................... ............................................................................... 13 “ 注意 ” 符號 ..................................................................... ............................................................................ 13 “ 制造商 ” 符號 .......................................