GB 12259-1990
Abolished
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
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
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
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced