GB 11234-1995
Replaced
YY/T 1405-2016
Active
Industry standards-Medicine
YY/T 1405-2016 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests
YY/T 1405-2016 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests
Basic Information
Standard Code:
YY/T 1405-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Other specialized equipment
ICS Name:
Population control, contraceptive devices
Publish Date:
2016-03-23
Implement Date:
2017-01-01
Pages:
25 pages
Scope
This standard specifies the minimum requirements and testing methods for reusable natural and silicone rubber vaginal diaphragms. The intended use of these diaphragms is for contraception.
This standard applies to reusable vaginal diaphragms made from natural rubber and silicone rubber.
This standard does not apply to other vaginal contraceptive barriers, such as cervical caps, vaginal sponges, and vaginal sheaths.
Development Information
Referenced Standards
ISO 463
GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
GB/T 3512-2001 Rubber, vulcanized or thermoplastic—Accelerated ageing and heat resistance tests—Air-oven method
GB/T 3512-2014 Rubber, vulcanized or thermoplastic—Accelerated ageing and heat resistance tests—Air-oven method
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
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
Adopt standards
ISO 8009:2004
ISO 8009:2004/FDAM 1:2012(E)
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