YY0284-2004氦氖激光血管内照射治疗仪通用技术条件.pdf

《YY0284-2004氦氖激光血管内照射治疗仪通用技术条件.pdf》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、11.040.50ICCS41yy中华人民共和国医药行业标准YY0284-2004代替YY0284-1996氦氖激光血管内照射治疗仪通用技术条件ThegeneralspecificationofHe-NelasermedicalinstrumentforILIB2004-03-23发布2005-01-01实施国家食品药品监督管理局发布YY0284-2004目次月a舀··························。·····。····。。····。。·······················

2、············。。······。·····。。················。·⋯⋯扭1范围···············································································································⋯⋯12规范性引用文件··············································································

3、··················⋯⋯13术语和定义······································································································⋯⋯14分类与基本参数·······························································································⋯⋯25要求···········

4、···························，········································································⋯⋯26试验方法········································································································⋯⋯37检验规则·...............................

5、...............................................................................58标志、标签和使用说明书·······························································................⋯⋯59包装、运输、贮存·····································································

6、························⋯⋯6附录A(规范性附录)安全·················································································...⋯⋯8附录B(规范性附录)环境试验细则········································································⋯⋯25YY0284-2004月9吕本标准是适用于氦氖激光血管内照射治疗仪(

7、简称内照仪)的通用技术条件，属氦氖激光类的专用标准，GB12257-2000(氦氖激光治疗仪通用技术条件》已将其单独划出。本标准的安全性能要求直接引用GB7247.1-2001《激光产品的安全第一部分:设备分类、要求和用户指南》,GB9706.1-1995《医用电气设备第一部分:安全通用要求》，并将其内容列人附录A(规范性附录)中。为了包含具有内照射功能的多功能治疗仪，对于超过3A类可达发射极限的设备，除了内照射部分应满足输出极限要求外，其安全性能还应符合GB9706.20-2000的要求。为此，附

8、录A中增加了3B类设备的附加要求。本标准是对YY0284-1996(氦氖激光血管内照射治疗仪通用技术条件》的修订，本标准代替YY0284-19960本次修订的重大技术变化是，突出了血管内照射输出极限的要求，确保内照射治疗中的生物安全。作为专用标准的要求，光针(无论是P型或是C型)的配套性能要求已作简化，但规定应配用一次性使用的注册产品。对激光设备及电气安全分类作出了放宽，增加了产品开发设计的技术可选性和灵活性。增加了附录A(规范性附录)安全等等。对于其他光源的内照仪，