YY 0033-2000: Translated English of Chinese Standard. YY0033-2000: Good manufacture practice for sterile medical devices [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]

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https://www.chinesestandard.net, 2015 M02 13 - 26 pages
This Standard specifies the general requirements of production and quality management for sterile medical devices and the components and parts. Production of primary package material of sterile medical devices shall also need to meet the requirements of this Standard.
 

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Contents

Foreword
3
Scope
5
Definitions
6
Quality system
7
Production environment facility and layout
9
Facility and work clothes
12
Purchasing and material management
13
Document
14
Quality management
15
Production process management
16
Hygienic management
18
Product sales and customer service
19
Annex A
20
Annex B
21
Annex E
25
Annex F
26

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About the author (2015)

https://www.chinesestandard.net specializes in providing translation services of all Chinese Standards.

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