YY/T 0202-2004医用诊断X射线体层摄影装置.pdf

ICS 11.040.50 C 43 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-raydevicefortomography 2004-11-08发布 2005-11-01实施 国家食品药品监督管理局 发布 YY/T 0202-2004 目 次 前言 ·································，·············································································，··… 1 范围 ·······································，·······················，…… 2规范性引用文件 ··································，············，·········，，·······……““”“”·‘.‘.“”””“““ 3术语和定义 ·····························································……”······一’““”’““”““‘”””’“‘ 4分类 ··…… 5 要求 ········································‘····································································…… 试验方法 -. - - .. … 。。… … 1...-. ‘，，. … … 。。. … ，… 。。..… ，. … … ‘..… 检验规则 8标志、标签和说明书············································，···········································，··…10 9包装、运输、贮存···，····················，· ··································································，，··…11 附录A(规范性附录)安全·························，，·····················，，·········，，，··········，·······……“.‘12 附录B(资料性附录)体层厚度计算公式的推导·························································……27 标准分享网 免费下载 YY/T0202-2004 Hii 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