YY/T 0334-2022 Active Industry standards-Medicine

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

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

Publish Date: 2022-08-17 Implement Date: 2023-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0334-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-08-17

Implement Date: 2023-09-01

Pages: 15 pages

Scope

This document specifies the general requirements for the chemical and biological properties, sterility, packaging, and labeling of silicone rubber surgical implants.
This document is applicable to the testing and evaluation of silicone rubber surgical implants.
Note 1: This document does not specify specific indicators for the physical and mechanical properties of implants.
Note 2: For silicone rubber surgical implants that have been added with substances such as color masterbatches and developers to enhance the functionality of the products, manufacturers can refer to this document for implementation based on risk assessments.

Development Information

Word Count: 32 Thousand words Pages: 15 pages

Replace the following standards

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

Referenced Standards

中华人民共和国药典(2020年版)四部 GB/T 601-2002 Chemical reagent Preparations of standard volumetric solutions GB/T 601-2016 Chemical reagent—Preparations of reference titration solutions GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 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

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