Standard No.:	YY 0603-2015
English Name:	Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems(with/without filter)and soft venous reservoir bags
Chinese Name:	心血管植入物及人工器官 心脏手术硬壳 贮血器/静脉贮血器系统（带或不带过滤器）和静脉贮血软袋
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
Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2017-1-1
Status:	to be superseded
Superseded by:	YY 0603-2024 Cardiopulmonary bypass systems—Hard-shell cardiotomy/venous reservoir systems(with/without filter)and soft venous reservoir bags
Superseded on:	2027-7-20
Superseding:	YY 0603-2007 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Language:	English
File Format:	PDF
Word Count:	7000 words
Price(USD):	210.00
Delivery:	via email in 1~3 business day

本标准代替YY 0603-2007《心血管植入物及人工器官 心脏手术硬壳 贮血器/静脉贮血器系统（带或不带过滤器）和静脉贮血软袋》。
本标准规定了对无菌、一次性使用的体外循环心脏手术硬壳贮血器、静脉贮血器系统（带或不带过滤器）和静脉贮血软袋（简称贮血器）的试验方法、标志、标签、使用说明书、包装、运输和贮存等要求。上述器件拟供进行心肺转流手术（CPB）时贮血使用。
本标准适用于多功能系统的贮血器件，该系统可能有整体性的部件，如血气交换器（氧合器）、血液过滤器、祛泡器、血泵等。