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Quality test method of steam in medical sterilization process
Standard in brief
Scope of Application:
本标准适用于医疗器械灭菌过程所使用蒸汽的质量测试。示例:压力蒸汽灭菌、环氧乙烷灭菌等灭菌过程中所使用的蒸汽。本标准规定了灭菌蒸汽的非冷凝气体含量、干燥度、过热度、蒸汽冷凝物等质量参数的测试方法。注: 以上蒸汽质量参数的要求见相应的产品标准。附录A中给出了一些蒸汽质量的要求。
Basic information
Standard No:YY/T 1612-2018
Standard Name:医用灭菌蒸汽质量的测试方法
English Name:Quality test method of steam in medical sterilization process
Standard Status:现行
Release Date:2018-09-29
Effective Date:2019-10-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.080.10
CCS Number:C47
Related Standards
Referenced Standards:GB/T 5750.5-2006,GB/T 8538-2008,GB 8599-2008,GB/T 11911-1989,GB/T 12149-2007,GB/T 14233.1-2008,GB/T 19971-2015
Publication Information
Number of pages:16
Number of words:24 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2018-10-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1612
Drafter:许荣凯、胡昌明、韩聪、吕连生、韩建康
Drafting Organization:山东新华医疗器械股份有限公司、广东省医疗器械质量监督检验所、北京麦迪锦诚医用品有限公司
Management Organization:全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Proposing Department:国家药品监督管理局