Standard No.:	YY/T 0730-2009
English Name:	Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO)
Chinese Name:	心血管外科植入物和人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求
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:	SFDA
Issued on:	2009-6-16
Implemented on:	2010-12-1
Status:	superseded
Superseded by:	YY/T 0730-2023 Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO)
Superseded on:	2024-1-15
Target Language:	English
File Format:	PDF
Word Count:	5000 words
Translation Price(USD):	150.00
Delivery:	via email in 1~3 business day

本标准规定了心肺旁路和体外膜肺氧合(ECMO)使用的一次性使用管道套包的要求,适用于所有拟用于心肺旁路(CPB)以及/或者体外膜肺氧合(ECMO)的医用管道,但对于在CPB 手术(短期,如6h以下)或ECMO(长期,如24h以上)期间拟与血泵一起使用的管道,应符合规定的要求和试验。本标准中有关无菌及无热原的规定适用于标有无菌字样的管道套包。
本标准仅适用于多功能设备的管道,该多功能设备具备完整的部件,如血气交换器(氧合器)、贮血器、血液微栓过滤器、祛沫剂、血泵等。