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

Publish Date: 2023-06-20 Implement Date: 2024-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 36 Thousand words Pages: 20 pages

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

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