yyt 0094-2004 医用诊断 x射线透视荧光屏

yyt 0094-2004 医用诊断 x射线透视荧光屏

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1、ICS11.040.50C43YY中华人民共和国医药行业标准YY/T0094-2004代替YY0094-1992医用诊断X射线透视荧光屏X-rayfluorescentscreensformedicaldiagnosis2004-11-08发布2005-11-01实施国家食品药品监督管理局发布YY/T0094-2004目次前言····························································································,,··················⋯⋯1范围··········

2、··················································‘,···································,········⋯⋯2规范性引用文件··········································································⋯⋯”’“⋯“““二‘二”·3术语和定义,·······-·,·······,···,··························‘···。····································,

3、········⋯⋯4要求·······························································‘,··································,·········,·⋯5试验方法··························································。··············································⋯⋯6检验规则·4····················‘············甲,············

4、·,············‘······················‘···,······,,一7标志、标签、使用说明书························································································,·⋯8包装、运输、贮存···············,···········,······················,,··········,·································⋯⋯9其他·······,·········..........

5、.........................................................................................表奄.‘公称尺寸,,,,·⋯表n乙英制公称尺寸⋯表gd逐批检查···⋯⋯表吐周期检查··⋯⋯YY/T0094-2004月U吕本标准代替YY0094-1992《医用X射线透视荧光屏》。本标准和YY0094-1992相比主要变化如下:—荧光屏的尺寸的常用规格作了增加,极限偏差也作了划分;—荧光屏的发光亮度的要求有了提高;—荧光屏的发光光谱能量分布主峰值范围作了调整;—荧光屏的发光均匀性的要求提出了新的指标

6、;—荧光屏的表面质量提出了定量的要求。本标准由国家食品药品监督管理局提出。本标准由全国医用X线设备及用具标准化分技术委员会归口。本标准由上海医疗器械股份有限公司齿科医械厂负责起草。本标准主要起草人:夏国成、孟红卫。本标准所代替的历次版本发布情况为:WS2-207-1982,YY0094-1992YY/T0094-2004医用诊断X射线透视荧光屏范围本标准规定了医用诊断x射线透视荧光屏的分类、要求、试验方法、检验规则、标志、标签、使用说明书、包装、运输、贮存的要求。本标准适用于医用诊断x射线透视荧光屏(以下简称荧光屏)。该产品用于将X射线转换成可见光2规范性引用文件下列文件中的

7、条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。GB/T191-2000包装储运图示标志GB/T2828.1-2003计数抽样检验程序按接收质量限(AQL)检索的逐批检验抽样计划(ISO2859.1;1999)GB/T2829-2002周期检验计数抽样程序及表(适用于对过程稳定性的检验)GB9969.1-1998

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