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]
https://www.chinesestandard.net, 13. 2. 2015 - 26 strán (strany)
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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Production environment facility and layout
Facility and work clothes
Purchasing and material management
Production process management
Product sales and customer service
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