GB 15980-1995: Hygienic standard of disinfection for single use medical products

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Scope

This Standard specifies the single use medical products’ hygiene standards, before
and after sterilization and disinfection. This Standard provides the quality control of
hygiene requirements to the manufacturing process such as manufacturing, assembly,
packaging workshop, and manufacturing workers’ hands in manufacturing enterprises
of single use medical products (including sterilized and disinfected single use medical
products).
This Standard applies to manufacturing enterprises of all types of single use medical
products. And it also applies to sterilization and disinfection service organizations.

Basic Data

Standard ID	GB 15980-1995 (GB15980-1995)
Description (Translated English)	Hygienic standard of disinfection for single use medical products
Sector / Industry	National Standard
Classification of Chinese Standard	C48
Classification of International Standard	11.120.20
Word Count Estimation	9,949
Date of Issue	1996-01-23
Date of Implementation	1996-07-01
Quoted Standard	GB 7918.2; GB 8368; GB 8369; GBJ 4883; Chinese Pharmacopoeia (1990 edition)
Issuing agency(ies)	State Bureau of Technical Supervision, Ministry of Health of the People Republic of China
Summary	This Chinese standard specifies the use of disposable medical supplies sterilization, disinfection before and after the standards of hygiene. This standard single-use medical supplies (including sterilization and disinfection of disposable medical supplies) production enterprises in the production, assembly, packaging workshop and other production processes and production workers hand- made ??sanitary requirements for quality control. This standard applies to all types of single-use medical products manufacturing enterprises, but also for sterilization and disinfection services units.