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GB 18282.3-2009 Sterilization of health care products—Chemical indicators—Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Standard No.:
GB 18282.3-2009
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:
2010-12-01
Delivery:
via email in 1-3 business day
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Detail
Introduction
Contents
Standard No.:
GB 18282.3-2009
Chinese Name:
医疗保健产品灭菌 化学指示物 第3部分:用于BD类蒸汽渗透测试的二类指示物系统
English Name:
Sterilization of health care products—Chemical indicators—Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Professional Classification:
C47 Public medical equipment
Professional Classification:
GB National Standard
ICS Classification:
11.080.01 Sterilization and disinfection in general
Issued by:
Issued on:
2009-11-15
Implemented on:
2010-12-01
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
引言Ⅳ
1 范围1
2 规范性引用文件1
3 术语和定义1
4 通用要求1
5 指示物系统的构成1
6 性能要求2
7 包装和标签2
8 质量保证3
附录A (规范性附录) 蒸汽灭菌后的强度评价4
附录B (规范性附录) 通过测定相对反射密度评估衬底与有变化(或无变化)的指示物系统之间的
颜色可见差异5
附录C (规范性附录) 暴露于饱和蒸汽中的指示物的颜色变化评价8
附录D (规范性附录) 暴露于干热环境的指示物颜色变化评价9
附录E (规范性附录) 测试样品的加速老化10
附录F (规范性附录) 测试过程中指示物向标准测试包转移评价11
附录G (规范性附录) 产品有效期的确定12
附录H (规范性附录) 蒸汽暴露装置13
附录I(规范性附录) 指示物对空气存在的检测灵敏度评价14
附录J(规范性附录) 空气注入系统15
附录K (规范性附录) 标准测试包16
参考文献17
GB 18282.3-2009 The following standards are cited:
GB 18282.3-2009 Cited by the following standards:
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