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YY/T 1302.2-2015 Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
Standard No.:
YY/T 1302.2-2015
Status:
VALID
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Email:
OK
Target Language:
English
File Format:
PDF
Word Count:
12000 words
Translation Price:
360 (USD)
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Email:
OK
Implemented on:
2016-01-01
Delivery:
via email in 1-3 business day
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Detail
Introduction
Contents
Standard No.:
YY/T 1302.2-2015
Chinese Name:
环氧乙烷灭菌的物理和微生物性能要求 第2部分:微生物要求
English Name:
Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
Professional Classification:
YY Professional Standard - Pharmaceutics
ICS Classification:
11.080.01 Sterilization and disinfection in general
Issued by:
Issued on:
2015-03-02
Implemented on:
2016-01-01
Status:
VALID
Target Language:
English
File Format:
PDF
Word Count:
12000 words
Translation Price:
360 (USD)
Delivery:
via email in 1-3 business day
前言 Ⅲ
1 范围 1
2 规范性引用文件 1
3 术语和定义 2
4 过程定义 2
4.1 过程定义考虑事项 2
4.2 过程定义方法 4
4.3 灭菌过程定义疑难解答 9
4.4 过程挑战装置(PCD) 10
5 确认 12
5.1 微生物性能鉴定(MPQ) 12
5.2 灭菌装载 13
5.3 模拟预期过程条件 14
5.4 确认装载的放行 14
5.5 小批量放行 14
6 过程有效性维护 15
6.1 失败调查 15
6.2 再鉴定 16
YY/T 1302.2-2015 The following standards are cited:
YY/T 1302.2-2015 Cited by the following standards:
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