YY/T 0094-2004 医用诊断X射线透视荧光屏

ICS11.040.50

C43

YY

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-rayfluorescentscreensformedicaldiagnosis

2004-11-08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规范性引用文件··········································································……”’“…“““二二‘”·

3术语和定义，·······-·，·······，···，··························‘···。····································，········……

4要求·······························································，‘··································，·········，·…

5试验方法··························································。··············································……

6检验规则4······················‘···········甲，·············，············‘······················‘···，······，，一

7标志、标签、使用说明书························································································，·…

8包装、运输、贮存···············，···········，······················，，··········，·································……

9其他·······，·········

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;

—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,YY0094-1992

YY/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工业产品使用说明书总则

GB/T10149-1988医用x射线设备术语和符号(neaIEC607881984)

术语和定义

GB/T10149-1988确立的以及下列术语和定义适用于本标准。

3.1

极限分辨率limitingresolution

把模板上相距最小的两个相邻线对，作为可以区分的影像信息成像于胶片的能力为分辨率。荧光

屏极限分辨率是使用荧光屏对分辨率测试卡在x射线胶片上成像，人眼能分辨的每毫米最高线对数。

3.2