GB 11234-1995
Replaced
GB 11236-2021
Active
National standards
force_standard
GB 11236-2021 Copper-bearing contraceptive intrauterine devices—Requirements and tests
GB 11236-2021 Copper-bearing contraceptive intrauterine devices—Requirements and tests
Basic Information
Standard Code:
GB 11236-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Other specialized equipment
ICS Name:
Population control, contraceptive devices
Publish Date:
2021-12-01
Implement Date:
2023-12-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
13 pages
Scope
本文件规定了含铜宫内节育器的预期性能、设计属性、材料、设计评估、制造和检验、灭菌、包装和制造商提供的信息。
本文件适用于一次性使用含铜宫内节育器及其放置器。
本文件不适用于塑料为主体的或主要用于释放孕激素的宫内节育器。
Development Information
Replace the following standards
Referenced Standards
YY/T 0640-2016 Non-active surgical implants—General requirements
中华人民共和国药典(2020版)
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 0297-1997 Clinical investigation of medical devices
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
YY/T 0297-2026 General requirements for clinical investigation of medical devices
Adopt standards
ISO 7439:2015
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