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
Price:
$ 38
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
Pages:
16 pages
Scope
This document specifies the expected performance, design attributes, materials, design evaluation, manufacturing and inspection, sterilization, packaging, and manufacturer's information for copper-containing intrauterine devices (IUDs).
This document applies to single-use copper-containing IUDs and their placement devices.
This document does not apply to IUDs primarily made of plastic or those primarily used for releasing progesterone.
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