YY/T 1914-2023 Active Industry standards-Medicine

YY/T 1914-2023 Medical devices for human assisted reproductive technology—General requirements of apparatus products

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1914-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2023-09-05

Implement Date: 2024-09-15

Publisher: 国家药品监督管理局

Technical Committee: 中国食品药品检定研究院

Pages: 8 pages

Scope

本文件规定了人类辅助生殖技术用医疗器械器具类产品的通用要求，包括要求和试验方法。
本文件适用于人类辅助生殖技术用医疗器械器具类产品，包括辅助生殖导管、辅助生殖穿刺取卵/取精针，以及辅助生殖微型工具。

Development Information

Drafting Units:

中国食品药品检定研究院、山东省医疗器械和药品包装检验研究院、瑞柏生物(中国)股份有限公司、太平洋康泰科学仪器(济南)有限公司、艾尔斯(浙江)医学科技有限公司

Drafting Persons:

李崇崇、韩倩倩、毛歆、赵丹妹、王涵、卢文博、冯怀亮、毕胜成、千日成、付步芳、刘丽、陈丹丹、刘叶

Word Count: 13 Thousand words Pages: 8 pages

Referenced Standards

GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 中华人民共和国药典(2020年版)　四部 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 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) YY/T 1688-2021 Medical devices for human assisted reproductive technology—A method for blastocyst cell staining and counting

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