Standard No.:	YY 1048-2016
English Name:	Cardiopulmonary bypass systems―Extracorporeal blood circuit
Chinese Name:	心肺转流系统体外循环管道
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-03-23
Implemented on:	2018-1-1
Status:	valid
Superseding:	YY 1048-2007 Artificial heart-lung machine-extracorporeal blood circuit
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	160.0
Delivery:	via email in 1~3 business day

本标准适用于人工心肺机使用的体外循环管道以及与其连为一体的附属管路，该产品在心血管及相关手术中供体外循环作为血液通道及通道连接一次性使用。
本标准规定了心肺转流系统体外循环管道的分类与命名、要求、试验方法、标志、包装、运输、贮存等内容。