YY 0033-2000: Good manufacture practice for sterile medical devices

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Scope

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.

Basic Data

Standard ID	YY 0033-2000 (YY0033-2000)
Description (Translated English)	Good manufacture practice for sterile medical devices
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C30
Word Count Estimation	13,184
Date of Issue	2000-08-18
Date of Implementation	2000-09-15
Older Standard (superseded by this standard)	YY/T 0033-1990
Quoted Standard	GB/T 6583-1994; GB/T 16292-1996; GB/T 16293-1996; GB/T 16294-1996; YY/T 0313-1998; JGJ 71-1990
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the sterile medical instruments and parts production and quality management of the basic requirements. Sterile medical devices early production of packaging materials shall also comply with the requirements of this standard.