YY/T 1850-2023 Active Industry standards-Medicine

YY/T 1850-2023 Male condoms—Requirements and test methods for condoms made from polyurethane

YY/T 1850-2023 Male condoms—Requirements and test methods for condoms made from polyurethane

Publish Date: 2023-01-13 Implement Date: 2024-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1850-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Population control, contraceptive devices
Publish Date: 2023-01-13
Implement Date: 2024-01-15
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: 48 pages

Scope

本文件规定了由聚氨酯胶乳制造,提供给消费者用于避孕和有助于防止性传播疾病的男用避孕套的最低技术要求和试验方法。
本文件适用于100%的聚氨酯避孕套以及聚氨酯胶乳为主体材料的其他复合型男用避孕套。

Development Information

Drafting Units:

兰州科天健康科技股份有限公司、上海市医疗器械检测所、河南省医疗器械检验所、青岛伦敦杜蕾斯有限公司(利洁时(中国)投资有限公司)、武汉杰士邦卫生用品有限公司、甘肃省医疗器械检验所、合肥科天水性科技有限责任公司

Drafting Persons:

陈亮、姚天平、王海涛、王志远、钱心依、贾云昆、任邯生、冯林林、张峻梓、孙开峰、任娟、陈大雷、王泽玮、徐会平、李维虎、朱有奎

Word Count: 98 Thousand words Pages: 48 pages

Referenced Standards

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 ISO/TR 8550(所有部分) 中华人民共和国药典(2020年版) GB 7544-2004 Natural latex rubber condoms-Requirements and test methods GB/T 7544-2009 Natural latex rubber condoms—Requirements and test methods GB/T 7544-2019 Natural rubber latex male condoms—Requirements and test methods GB 7544.1-1999 Rubber condoms—Part 1:Requirements GB/T 7544.2-1999 Rubber condoms—Part 2:Determination of length GB/T 7544.3-1999 Rubber condoms—Part 3:Determination of width GB/T 7544.5-1999 Rubber condoms—Part 5:Testing for holes-Water leak test GB/T 7544.6-1999 Rubber condoms—Part 6:Determination of bursting volume and pressure GB/T 7544.7-1999 Rubber condoms—Part 7:Oven conditioning GB/T 7544.9-1999 Rubber condoms—Part 9:Determination of tensile properties GB/T 7544.10-1999 Rubber condoms—Part 10:Packaging and labelling—Condoms in consumer packages 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 GB/T 19000-2000 Quality management systems—Fundamentals and vocabulary GB/T 19000-2008 Quality management systems—Fundamentals and vocabulary GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary GB/T 19000.2-1998 Quality management and quality assurance standards—Part 2:Generic guidelines for the application of GB/T 19001、GB/T 19002 and GB/T 19003 GB/T 19000.3-2001 Quality management and quality assurance standards—Part 3:Guidelines for the application of GB/T 19001-1994 to the development, supply, installation and maintenance of computer software GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management 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 1777-2021 Male condoms—Requirements and test methods for condoms made from synthetic materials YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

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