Standard No.:	YY 0604-2016
English Name:	Cardiopulmonary bypass systems―Blood-gas exchangers(oxygenators)
Chinese Name:	心肺转流系统血气交换器（氧合器）
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 0604-2007 Cardiovascular implants and artificial organs—Blood-gas exchangers(oxygenators)
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	250.0
Delivery:	via email in 1~3 business day

本标准适用于心肺转流系统使用的血气交换器（氧合器），也适用于作为氧合器整体一部分的热交换器。本标准规定了无菌、一次性使用的心肺转流系统使用的血气交换器（氧合器）的要求。
本标准不适用于植入式氧合器、液态氧合器、体外循环管道、分离式热交换器、分离式附件。