YY/T 1929-2024 Active Industry standards-Medicine

YY/T 1929-2024 Breast biopsy and excision equipment

Publish Date: 2024-02-07 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1929-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical instruments and materials

Publish Date: 2024-02-07

Implement Date: 2025-03-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)

Pages: 20 pages

Scope

本文件界定了乳房活检与旋切设备及旋切针的术语和定义，规定了材料、要求，描述了相应的试验方法。本文件适用于乳房活检与旋切设备。

Development Information

Drafting Units:

重庆西山科技股份有限公司、上海市医疗器械检验研究院、重庆市药品技术审评查验中心、麦默通医疗器械制造(上海)有限公司、巴德医疗科技(上海)有限公司、上海修能医疗器械有限公司

Drafting Persons:

郭毅军、余元骏、陈弸中、徐超、郑文浩、顾丽华、岳鑫、蒋小奇、张燕青、陈竹、孙赟辉

Word Count: 23 Thousand words Pages: 20 pages

Referenced Standards

GB/T 1220-2007 Stainless steel bars GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices 中华人民共和国药典(2020版) GB/T 2965-1996 Titanium and titanium alloy bars GB/T 2965-2007 Titanium and titanium alloy bars GB/T 2965-2023 Titanium and titanium alloy bars GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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