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, 2015/02/13 - 26 ページ
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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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目次

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

多く使われている語句

1/month air locks Air purification air shower airborne microbe ancillary area Annex anti-pollution Class of Production Clean Production Area clean room area clean work clothes cleaned and sterilized cleanliness class cleanliness clean area compatible contacted with product control of nonconforming corrective and preventive device manufacturing enterprise different cleanliness clean Drug Administration effect to product entering into clean Enterprise shall establish Environment for Sterile evaluation Figure D2 final cleaning In-and-Out of Clean intermediate-products laminar flow management document Manufacture Practice medical device production meet the requirements microbiology monitoring items nonconforming product Personnel In-and-Out personnel purification room piece/m3 pollution preventive actions Principle of Cleanliness Procedure of Personnel process water product quality production and quality production environment production lot production technology Quality management department quality management system quality record relevant requirements of production requirements of quality settling microbe sterile medical device sterilization method storage strictly separated technical documents use-surface verification and validation waiting for inspection YY/T

著者について (2015)

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

書誌情報

QR code for YY 0033-2000: Translated English of Chinese Standard. YY0033-2000
書籍名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]
著者https://www.chinesestandard.net
出版社https://www.chinesestandard.net, 2015
ページ数26 ページ
  
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