YY/T 0334-2022 Active Industry standards-Medicine

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

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

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 15 pages

Scope

本文件规定了硅橡胶外科植入物的化学及生物性能、无菌、包装与标志的通用要求。
本文件适用于硅橡胶外科植入物的测试评价。
注1：本文件未规定植入物的物理机械性能的具体指标。
注2：对于为了增加产品的功能性而添加了诸如色母料、显影剂等的硅橡胶外科植入物，制造商可基于风险评定参照执行本文件。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、苏州百特医疗用品有限公司研发分公司、先健科技(深圳)有限公司、贝朗医疗(上海)国际贸易有限公司

Drafting Persons:

刘莉莉、崔双进、梁辉、刘叶、吕娇龙、刘攀攀、姜洪霞、王晨晓

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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