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

Publish Date: 2016-03-23 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 46 Thousand words Pages: 25 pages

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)

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