YY 0334-2002: [Including 2013XG] General specification for surgical implants made of silicone elastomer

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Scope

This Standard specifies general requirements for chemical and biological properties,
sterility, packaging and marking of surgical implants consisting solely of silicone
elastomer. Specific mechanical and physical properties of implants have not been
specified.
These surgical implants are intended for use in orthopaedic and restorative surgery.
Implants made of silicone elastomers together with other materials are excluded.

Basic Data

Standard ID	YY 0334-2002 (YY0334-2002)
Description (Translated English)	[Including 2013XG] General specification for surgical implants made of silicone elastomer
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C31
Word Count Estimation	15,147
Date of Issue	2002-04-25
Date of Implementation	2002-10-01
Adopted Standard	BS 7253-3-1990, MOD
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the silicone rubber surgical implants chemical and biological properties, sterile, packaging and identification of common requirements. Unspecified physical and mechanical properties of the implant specific indicators. These implants are mainly used in orthopedic surgery and repair. Silicone rubber and other materials together with surgical implants are not included in the scope of this standard.