Standard No.:	YY 0677-2008
English Name:	Liquidnitrogen cryosurgical equipment
Chinese Name:	液氮冷冻外科治疗设备
Chinese Classification:	C37    General requirements on medical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Administration
Issued on:	2008-10-17
Implemented on:	2010-6-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	160.0
Delivery:	via email in 1~3 business day

本标准规定了液氮冷冻外科治疗设备的范围、定义和术语、要求、试验方法、检验规则及标志、标签、包装等要求。
本标准适用于制冷剂为液氮，利用其汽化相变潜热制冷，且液氮存贮器容量大于1L的冷冻外科治疗设备。治疗设备主要对靶组织产生低温，用于冷冻坏死、冷冻阻滞、炎性反应及冷冻粘连用。