YY/T 0776-2023 Active Industry standards-Medicine

YY/T 0776-2023 Radio frequency ablation equipment for liver

Publish Date: 2023-06-20 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0776-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Physiotherapy and traditional Chinese medicine instruments and equipment

ICS Name: Treatment equipment

Publish Date: 2023-06-20

Implement Date: 2025-07-01

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物理治疗设备分技术委员会(SAC/TC 10/SC 4)

Pages: 12 pages

Scope

本文件规定了肝脏射频消融治疗设备（以下简称“设备”)及其配用附件的要求、试验方法。
本文件适用于肝脏射频消融治疗设备及其配用附件。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、迈德医疗科技(上海)有限公司

Drafting Persons:

刘博、杨建刚、张龙飞、李雅楠、候飞翔、卢苏阳

Word Count: 20 Thousand words Pages: 12 pages

Replace the following standards

YY/T 0776-2010 Radio frequency ablation instrument for liver

Referenced Standards

GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests 中华人民共和国药典 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 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance YY/T 1057-2016 General specifications for medical foot switch YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical instruments YY 1057-2016 General specifications for medical foot switch

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