YY 0838-2021 Active Industry standards-Medicine

YY 0838-2021 Microwave ablation/coagulation equipment

Publish Date: 2021-03-09 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0838-2021

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: 2021-03-09

Implement Date: 2023-05-01

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

本标准规定了微波热凝设备(以下简称设备)的组成及分类、要求、试验方法。
本标准适用于使用接触应用器，在组织中传送频率大于300 MHz但不超过30 GHz的电磁场，使患者局部组织产生凝固/消融的医疗实践中使用的微波热凝设备，本标准也适用于具有微波热凝功能的组合设备。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、南京康友医疗科技有限公司、柯惠(中国)医疗器材技术有限公司、天津市顺博医疗设备有限公司

Drafting Persons:

段乔峰、叶明旸、刘辉、贾若贤、唐淑君、李明华

Word Count: 18 Thousand words Pages: 12 pages

Replace the following standards

YY 0838-2011 Microwave ablation/coagulation equipment

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 9706.206-2020 Medical electrical equipment—Part 2-6:Particular requirements for the basic safety and essential performance of microwave therapy equipment 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 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 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0899-2013 General requirements for accessories of microwave equipment in medical parctices YY 0899-2020 General requirements for accessories of microwave equipmentin medical practices YY/T 1057-2016 General specifications for medical foot switch YY 1057-2016 General specifications for medical foot switch

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