YY 0650-2022 Active Industry standards-Medicine

YY 0650-2022 General technical requirements for radio frequency ablation equipment

Publish Date: 2022-10-17 Implement Date: 2025-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0650-2022

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: 2022-10-17

Implement Date: 2025-11-01

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: 8 pages

Scope

本文件规定了射频消融治疗设备（以下简称设备)的术语和定义、要求、试验方法。
本文件适用于射频消融治疗设备及其附件。
本文件不适用于进行非创伤性浅表治疗的射频治疗设备。

Development Information

Word Count: 18 Thousand words Pages: 8 pages

Replace the following standards

YY 0650-2008 Gynecological radio frequency therapy instrument YY 0897-2013 Radio-frequency ablation equipment for ear,nose and throat

Referenced Standards

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 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 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 0778-2010 Radio frequency ablation catheter YY 0778-2018 Radio frequency ablation catheter YY/T 1057-2016 General specifications for medical foot switch YY 1057-2016 General specifications for medical foot switch

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