YY 0334-2002 Replaced Industry standards-Medicine

YY 0334-2002 General specification for surgical implants made of silicone elastomer

YY 0334-2002 General specification for surgical implants made of silicone elastomer

Publish Date: 2002-04-25 Implement Date: 2002-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0334-2002

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: -

Publish Date: 2002-04-25

Implement Date: 2002-10-01

Pages: 15 pages

Scope

This standard specifies the general requirements for the chemical and biological performance, sterility, packaging, and labeling of silicone rubber surgical implants. It does not stipulate specific indicators for the physical and mechanical performance of implants. These implants are primarily used in surgical orthopedics and repair. Surgical implants made of silicone rubber in combination with other materials are not included in the scope of this standard.

Development Information

Word Count: 22 Thousand words Pages: 15 pages

Superseded by the following standards

YY/T 0334-2022 General specification for surgical implants made of silicone elastomer

Referenced Standards

中华人民共和国药典二○○○年版 GB/T 601-2002 Chemical reagent Preparations of standard volumetric solutions GB/T 601-2016 Chemical reagent—Preparations of reference titration solutions GB/T 16175-1996 Organic silicon material for medical use—Biological evaluation test methods GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process YY/T 0313-1998 Package,lable,transport and storage for medical polymer products YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer

Adopt standards

BS 7253:P3:1990

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