Standard No.:	YY 0838-2011/XG1-2020
English Name:	Microwave ablation/coagulation equipment, includes Amendment 1
Chinese Name:	《微波热凝设备》含行业标准第1号修改单
Chinese Classification:	C42    Physiotherapy and TCM instrument and equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Source Content Issued by:	China Food and Drug Administration
Issued on:	2020-02-21
Implemented on:	2020-2-21
Status:	valid
Superseding:	YY 0838-2011 Microwave ablation/coagulation equipment
Target Language:	English
File Format:	PDF
Word Count:	9500 words
Translation Price(USD):	285.0
Delivery:	via email in 1~3 business day

本标准规定了微波热凝设备的术语和定义、组成及分类、要求、试验方法、检验规则、标志、包装、运输及贮存。
本标准适用于3.1所定义的医疗实践中使用的微波热凝设备的要求。
组合设备如具有微波热凝功能,热凝功能必须满足本标准要求,理疗部分应满足GB9706.6—2007《医用电气设备 第二部分:微波治疗设备安全专用要求》的要求。