GB 11234-1995
Replaced
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
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
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
GB 11236-1995
Replaced
GB 11236-1995 TCu intra-uterine devices
GB 3156-1995
Replaced
GB 3156-1995 OCu intra-uterine devices
GB 7544.1-1999
Abolished
GB 7544.1-1999 Rubber condoms—Part 1:Requirements
GB/T 7544.10-1999
Replaced
GB/T 7544.10-1999 Rubber condoms—Part 10:Packaging and labelling—Condoms in consumer packages
GB/T 7544.2-1999
Replaced