GB 11234-1995
Replaced
YY/T 1884-2023
Active
Industry standards-Medicine
YY/T 1884-2023 Fixed type copper-bearing intra-uterine contraceptive devices
YY/T 1884-2023 Fixed type copper-bearing intra-uterine contraceptive devices
Basic Information
Standard Code:
YY/T 1884-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Other specialized equipment
ICS Name:
Population control, contraceptive devices
Publish Date:
2023-06-20
Implement Date:
2024-07-01
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:
20 pages
Scope
本文件规定了固定式含铜宫内节育器的组成与基本尺寸、要求、试验方法、制造商提供的信息、包装和失效期。
本文件适用于固定式含铜宫内节育器,该产品固定于妇女子宫腔内,用作避孕。
Development Information
Drafting Units:
武汉卫民医疗器械有限责任公司、上海市医疗器械检验研究院、天津和杰医疗器械有限公司、重庆医疗器械质量检验中心
Drafting Persons:
孙新汉、姚天平、魏波、蒙明姜、潘宁、钱心依、秦娜、凡四杰
Referenced Standards
GB 11236-2021 Copper-bearing contraceptive intrauterine devices—Requirements and tests
GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 1404-2016 Requirements and tests for copper used for IUD
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
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