YY/T 1769-2022 Active Industry standards-Medicine

YY/T 1769-2022 Medical devices for human assisted reproductive technology—Artificial insemination catheter

YY/T 1769-2022 Medical devices for human assisted reproductive technology—Artificial insemination catheter

Publish Date: 2022-05-18 Implement Date: 2023-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1769-2022
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Surgical instruments and materials
Publish Date: 2022-05-18
Implement Date: 2023-06-01
Publisher: 国家药品监督管理局
Technical Committee: 中国食品药品检定研究院
Pages: 12 pages

Scope

本标准规定了人工授精导管的术语和定义、产品结构和组成、设计属性、要求和试验方法、包装、标志及说明书。
本标准适用于经阴道插入子宫腔内注入体外处理后精子,或子宫颈内注入体外处理后精液,进行人工授精的辅助生殖技术用人工授精导管。

Development Information

Drafting Units:

中国食品药品检定研究院、广州和弘生物科技有限责任公司、山东省医疗器械产品质量检验中心、四川大学(四川医疗器械生物材料和制品检验中心)、瑞柏生物(中国)股份有限公司

Drafting Persons:

王迎、韩倩倩、王春仁、李秋、梁洁、张庆、刘栋、冯雨、冯怀亮、李崇崇、付步芳、陈丹丹、付海洋、刘丽、柯林楠、古燕娥、梁洪彬

Word Count: 22 Thousand words Pages: 12 pages

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 15812.1-2005 Catheters other than intravascular catheters—Part 1:Test methods for common properties GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements YY 1282-2016 Intravenous catheter for single use 中华人民共和国药典(2015版第四部) GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB/T 9969-2008 General principles for preparation of instructions for use of industrial products GB 9969.1-1998 General principles for preparation of instructions for use of industrial products 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 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood 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 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0995-2015 Medical devices for human assisted reproductive technology—Terminology and definitions YY/T 1434-2016 Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology—Biological evaluation—Human sperm survival assay YY/T 1535-2024 Medical devices for human assisted reproductive technology—Human sperm viability assay(HSVA)

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