【正文】 ....................................................................................................... 14 “ 歐盟授權(quán)代表 ” 符號(hào) ...................................................................... .............................................................. 14 “ 充分進(jìn)行 ” 符號(hào) ........................................................................................................................................... 15 “ 僅供體外 診斷性能評(píng)估 ” 符號(hào) ..................................................................................................................... 15 “ 體外診斷醫(yī)療器械 ” 符號(hào) .............................................. ............................................................................... 16 包含溫度范圍指示的 “ 溫度范圍 ” 符號(hào) .......................................................................................................... 16 “ 參考使用說(shuō)明 ” 符號(hào) .................................................................................................................................... 18 “ 生物風(fēng)險(xiǎn) ” 符號(hào) .............................................................................................................................. ............ 18 “ 避免日曬 ” 符號(hào) .................................................................................................... ..................................... 18 “ 保持干燥 ” 符號(hào) ........................................................ ................................................................................... 19 “ 不可重復(fù)滅菌 ” 符號(hào) ....................................................... ............................................................................. 19 “ 非滅菌 ” 符號(hào) ............................................................................................................................. ................. 20 “ 對(duì)照 ” 符號(hào) .................................................................................................................................................. 20 “ 陰性對(duì)照 ” 符號(hào) .............................................................. ............................................................................. 21 “ 陽(yáng)性 對(duì)照 ” 符號(hào) ............................................................. .............................................................................. 21 6 新 符號(hào) ............................................................................................................................................................. 21 總則 ................................................................................... .............................................................................. 21 “ 含有或存在 天然膠乳 ”符號(hào) ...................................................................................................................... 22 “ 包裝破損切勿使用 ” 符號(hào) ............................................................................................................................ 22 “ 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 ........................................................................................ .................. 24 “ 使用期限 ” 符號(hào)的應(yīng)用舉例 .............................................. .................................................................. ......... 24 “ 批次代碼 ” 符號(hào)的應(yīng)用舉例 ............................................... ......................................................................... 24 “ 序列編號(hào) ” 符號(hào)的應(yīng)用舉例 .............................................. ........................................................................... 24 “ 制造日期 ” 符號(hào)的應(yīng)用舉例 ..................................................................................................... ................... 24 “ 分類(lèi)編號(hào) ” 符號(hào)的應(yīng)用舉例 .............................................. ........................................................................... 25 “ 制造商 ” 符號(hào)的應(yīng)用舉例 ............................................... .......................................... .................................. 25 結(jié)合“制造日期”的 “ 制造商 ” 符號(hào)的應(yīng)用舉例 ............................................................................................ 25 “歐盟授權(quán)代表” 符號(hào)的應(yīng)用舉例 ............................................................................................................... .... 25 “ 充分進(jìn)行 ” 符號(hào)的應(yīng)用舉例 ........................................................................................................................ 26 2 BS EN 980:2020 EN 980:2020 (E) “ 溫度上限 ” 符號(hào)的應(yīng)用舉例 ............................................................................................................................... 26 “ 溫度下限 ” 符號(hào)的應(yīng)用舉例 ..................................................................................................................... 26 “ 溫度限值 ” 符號(hào)的應(yīng)用舉例 ................................................................................ ..................................... 26 “ 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)效 符號(hào) 的應(yīng)用 ................................................................................................ 28 通 用禁止符號(hào) ............................................................... .............................................................................. 28 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 .........................................................................................