YY0503-2005环氧乙烷灭菌器.pdf

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1、ICS11.040C47YY中华人民共和国医药行业标准YY0503-2005环氧乙烷灭菌器Ethyleneoxidesterilizer(EN1422:1997,Sterilizersformedicalpurposes-Ethyleneoxidesterilizers-Requirementsandtestmethods,NEQ)2005-04-05发布2006-01-01实施国家食品药品监督管理局发布YY0503-2005目次月p舀··········，···············································，········，····

2、····，·····································⋯⋯皿1范围················································，·····························‘······················，······⋯⋯12规范性引用文件··············································································⋯⋯，，，，，......⋯⋯13术语和定义·························

3、·········································，·································⋯14分类与标记···············································，·，，，·················································⋯⋯25要求······································································································

4、·········⋯⋯36试验方法·········································································································⋯⋯87检验规则·······················································，···············································⋯⋯108标志、使用说明书··············································

5、···，·，··········，··············.........⋯⋯n9包装、运输、贮存·············，·························································，··，··················⋯⋯，，12YY0503-2005oil吕本标准除第7章检验规则为推荐性外，其余的全部技术内容为强制性。本标准非等效采用EN1422:1997(医用灭菌器—环氧乙烷灭菌器要求和测试方法》。本标准与EN1422:1997的主要技术差异如下:1)EN1422:1997中规定环氧乙烷灭菌器应符合使用

6、国压力容器的国家规范和标准，根据我国《压力容器安全技术监察规程》中规定，最高工作压力大于等于0.1MPa的压力容器应遵照该规程。环氧乙烷灭菌器根据环氧乙烷灭菌过程的特性，最高工作压力<0.1MPa，故国家规定的《压力容器安全技术监察规程》在本标准中不适用2)EN1422:1997中明确环氧乙烷灭菌器的电气安全性能要求，规定采用IEC1010-1:1990+A1:1992+A2:1995(我国等同采用为GB4793.1-1995(测量、控制和试验室用电气设备的安全要求第1部分:通用要求》但未包括1995年第二次修订文件)和IEC1010-2-042:1997《测量、控制和试验室用

7、电气设备的安全要求第2-042部分:使用有毒气体处理医用材料及供试验室用的高压消毒锅和灭菌器的专用要求》标准。因此，本标准的电气安全性能要求执行了上述规定。为此，在本标准中不采用GB9706.1-1995《医用电气设备第一部分:安全通用要求》本标准由国家食品药品监督管理局提出。本标准由全国消毒技术与设备标准化委员会归口。本标准起草单位:杭州电达消毒设备厂、国家食品药品监督管理局广州医疗器械质量监督检验中心。本标准主要起草人:周庆庆、申屠为农、高黎、阂捷、黄秀莲、卢子分。YY0503-2005