YY/T 1921-2023 Active Industry standards-Medicine

YY/T 1921-2023 Closed type copper-bearing contraceptive intrauterine devices

YY/T 1921-2023 Closed type copper-bearing contraceptive intrauterine devices

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1921-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Population control, contraceptive devices
Publish Date: 2023-09-05
Implement Date: 2024-09-15
Publisher: 国家药品监督管理局
Technical Committee: 全国计划生育器械标准化技术委员会(SAC/TC 169)
Pages: 16 pages

Scope

本文件规定了闭环式含铜宫内节育器(以下简称“节育器”)的组成与型式、要求、制造商提供的信息、包装和失效期,描述了相应的试验方法。
本文件适用于闭环式含铜宫内节育器及其放置器,该产品放置于妇女宫腔内作避孕用。

Development Information

Drafting Units:

武汉卫民医疗器械有限责任公司、上海医用缝合针厂有限公司、上海市医疗器械检验研究院、烟台计生药械有限公司、河南雅康药业有限公司、江苏省医疗器械检验所

Drafting Persons:

孙新汉、段卓、姚天平、田云霞、种秀云、郑涤新、尹凤霞、钱心依、顾小鱼、王伟光、陈正、李海琦

Word Count: 23 Thousand words Pages: 16 pages

Referenced Standards

GB 11236-2021 Copper-bearing contraceptive intrauterine devices—Requirements and tests YY/T 0334-2022 General specification for surgical implants made of silicone elastomer YY/T 0640-2016 Non-active surgical implants—General requirements YY/T 1471-2016 Requirements and tests for indomethacin rubber used for Cu-IUD 《中华人民共和国药典》(2020版) GB/T 4240-1993 Stainless steel wires GB/T 4240-2009 Stainless steel wires GB/T 4240-2019 Stainless steel wires GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method 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 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance YY/T 1404-2016 Requirements and tests for copper used for IUD YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical instruments

Related Standards

Contact Us