YY 0899-2020 Active Industry standards-Medicine

YY 0899-2020 General requirements for accessories of microwave equipmentin medical practices

YY 0899-2020 General requirements for accessories of microwave equipmentin medical practices

Publish Date: 2020-06-30 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0899-2020
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: 2020-06-30
Implement Date: 2022-06-01
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: 10 pages

Scope

本标准规定了医用微波设备附件的术语和定义、要求、试验方法。
本标准适用于为完成治疗目的,在医疗实践中与医用微波设备配合使用的医用微波设备附件。

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、安阳市翔宇医疗设备有限公司

Drafting Persons:

段乔峰、叶明旸、刘辉、贾若贤、唐淑君、李明华、李飞

Word Count: 18 Thousand words Pages: 10 pages

Replace the following standards

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals 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 9706.6-1992 Particular requirements for the safety of microwave therapy equipment GB 9706.6-2007 Medical electrical equipment—Part 2:Particular requirements for the safety of microwave therapy equipment 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 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 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance YY 0838-2011 Microwave ablation/coagulation equipment YY 0838-2021 Microwave ablation/coagulation equipment YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical instruments GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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