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1、ICS11.040.50C43中華人民共和國(guó)醫(yī)藥行業(yè)標(biāo)準(zhǔn)YY/T0128-2004代替YY0128-1993醫(yī)用診斷X射線輻射防護(hù)器具裝置及用具ProtectivedevicesagainstdiagnosticmedicalX-radiation-Deviceandtool2004-11-08發(fā)布2005-11-01實(shí)施國(guó)家食品藥品監(jiān)督管理局發(fā)布YYIT0128-2004目次前言··········································································································
2、·······??1范圍和目的························，，，，·························...................................................2規(guī)范性引用文件·············································，，···········，·········，··········一‘”‘二‘二’卜““‘’·3術(shù)語(yǔ)和定義········································································
3、······························??4要求介，，··?！ぁぁ?，·············，，········，甲，··················，，，，‘················，，，，······，甲··，········，，，甲?！ぁ?5試驗(yàn)方法···························································································?！ぁぁぁぁぁぁぁぁぁぁぁぁ??6檢驗(yàn)規(guī)則········································
4、，，··············································，·..................7標(biāo)志、標(biāo)簽····················，··········，···············································，·························??8包裝、運(yùn)輸和儲(chǔ)存································································································??表1逐批檢查??表2
5、周期檢查??YY/T0128-2004前言制定本標(biāo)準(zhǔn)使醫(yī)用診斷X射線輻射防護(hù)裝置及用具在生產(chǎn)制造和質(zhì)量檢驗(yàn)中有一個(gè)統(tǒng)一的要求，以保證和提高產(chǎn)品的質(zhì)量，確保安全有效。對(duì)醫(yī)用診斷X射線輻射的防護(hù)，除X射線機(jī)自身的設(shè)計(jì)必須符合標(biāo)準(zhǔn)的規(guī)定之外，在放射線的實(shí)踐中，還應(yīng)對(duì)X射線的輻射提供必要的附加防護(hù)措施，附加防護(hù)一般分為裝置類和用具類。裝置類中，包括防護(hù)屏、防護(hù)室、防護(hù)椅、防護(hù)門等。用具類中，包括防護(hù)眼鏡、防護(hù)面罩、防護(hù)簾等。作為防護(hù)，不應(yīng)理解為只是操作者的防護(hù)，同時(shí)，還應(yīng)考慮到對(duì)其他使用者及患者的防護(hù)，這是一個(gè)不容忽視的問(wèn)題。本標(biāo)準(zhǔn)增加了防護(hù)門、防護(hù)眼鏡、防護(hù)面罩和防護(hù)簾的要求。本標(biāo)準(zhǔn)由國(guó)家食品藥
6、品監(jiān)督管理局提出。本標(biāo)準(zhǔn)由全國(guó)醫(yī)用X線設(shè)備及用具標(biāo)準(zhǔn)化分技術(shù)委員會(huì)歸口。本標(biāo)準(zhǔn)起草單位:遼寧省醫(yī)療器械產(chǎn)品質(zhì)量監(jiān)督檢驗(yàn)所，沈陽(yáng)市衛(wèi)生監(jiān)督所。本標(biāo)準(zhǔn)主要起草人:夏連季、牟莉、張春生、王壽民。本標(biāo)準(zhǔn)代替標(biāo)準(zhǔn)的歷次版本發(fā)布情況:YY0128-19930YY/T0128-2004醫(yī)用診斷X射線輻射防護(hù)器具裝置及用具范圍和目的1.1范圍本標(biāo)準(zhǔn)適用于醫(yī)用診斷X射線輻射防護(hù)裝置(以下簡(jiǎn)稱裝置)及防護(hù)用具(以下簡(jiǎn)稱用具)。本標(biāo)準(zhǔn)涉及的裝置包括:醫(yī)用診斷X射線輻射防護(hù)屏(以下簡(jiǎn)稱防護(hù)屏)、醫(yī)用診斷X射線輻射防護(hù)室(以下簡(jiǎn)稱防護(hù)室)、醫(yī)用診斷X射線輻射防護(hù)門(以下簡(jiǎn)稱防護(hù)門)、醫(yī)用診斷X射線輻射防護(hù)椅(以下簡(jiǎn)
7、稱防護(hù)椅)。本標(biāo)準(zhǔn)涉及的用具包括:醫(yī)用診斷X射線輻射防護(hù)眼鏡(以下簡(jiǎn)稱防護(hù)眼鏡)、醫(yī)用診斷X射線輻射防護(hù)面罩(以下簡(jiǎn)稱防護(hù)面罩)、醫(yī)用診斷X射線輻射防護(hù)簾(以下簡(jiǎn)稱防護(hù)簾)。上述產(chǎn)品用于醫(yī)用診斷X射線輻射的防護(hù)。1.2目的本標(biāo)準(zhǔn)規(guī)定了裝置及用具的型式，要求，試驗(yàn)方法、檢驗(yàn)規(guī)則及標(biāo)志、標(biāo)簽、包裝、運(yùn)輸和貯存。2規(guī)范性引用文件下列文件中的條款通過(guò)本標(biāo)準(zhǔn)的引用而成為本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件，其隨后所有的修改單(不包括
