YYT0202-2004医用诊断X射线体层摄影装置.pdf

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1、ICS11.040.50C43中华人民共和国医药行业标准YY/T0202-2004代替YY/T0202-1995医用诊断X射线体层摄影装置MedicaldiagnosticX-raydevicefortomography2004-11-08发布2005-11-01实施国家食品药品监督管理局发布YY/T0202-2004目次前言·································，·············································································，··⋯1范

2、围·······································，············...........................................···········，⋯⋯2规范性引用文件··································，············，·········，，·······⋯⋯““”“”·‘.‘.“”””“““3术语和定义·····························································⋯⋯”······一’

3、““”’““”““‘”””’“‘4分类·............................................................................................................·⋯⋯5要求········································‘····································································⋯⋯-.--..⋯。。...............⋯⋯1...-.‘，，.

4、......⋯⋯。。.⋯，⋯。。..⋯，................⋯⋯‘..⋯试验方法检验规则8标志、标签和说明书············································，···········································，··⋯109包装、运输、贮存···，····················，···································································，，··⋯11附录A(规范性附录)安全·······

5、··················，，·····················，，·········，，，··········，·······⋯⋯“.‘12附录B(资料性附录)体层厚度计算公式的推导·························································⋯⋯27YY/T0202-2004Hii舀本标准代替YY/T0202-1995((医用X射线体层摄影装置》。本标准与YY/T0202-1995相比主要变化如下:—增加了前言;—标准名称及第三章所列出的各条术语均补充了英文名称;—根据医用诊断X射线

6、设备当前所必须遵守的关于产品安全通用或专用要求的系列国家标准的要求，以附录A(规范性附录)的形式将相关安全的内容增补人本标准之中，从而成为本标准的不可分割的一部分，并将原标准正文部分与安全有关具体条款均纳人到附录A的对应条款之中;—增加了关于产品应进行环境试验的条款;—增加了附录A;—本标准的目的在于阐明X射线体层摄影装置的性能，但是它的性能往往与同它相配套使用的X射线发生装置的性能是密切相关的，所以本标准中也对后者的相关性能提出了要求;—根据医用诊断X射线设备的特点，将原标准中按GB2828和GB2829抽样检验，改为:出厂检验为逐台进行，型式检验为抽检

7、一台。本标准的附录A是规范性附录，附录B是资料性附录。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。本标准起草单位:内江西南医用设备有限公司、辽宁省医疗器械产品质量监督检验所本标准主要起草人:邵其芳、屈艳。本标准代替标准的历次版本发布情况:YY/T0202-19950YY/T0202-2004医用诊断X射线体层摄影装置范围本标准规定了医用诊断X射线体层摄影装置(以下简称体层摄影装置)的术语、分类、要求、试验方法、检验规则和标志、标签、使用说明书以及包装、运输、贮存的要求。本标准适用于纵断层体层摄影用的医用诊断X射

8、线装置_该装置可供医疗单位作一般体层摄影、多层体层摄影之用。本标准