Standard Number: YY 0604-2016(YY0604-2016)
Chinese:心肺转流系统 血气交换器(氧合器）
English:Cardiopulmonary bypass systems- Blood-gas exchangers (Oxygenators)
Effective Date:2018-01-01
ICS:11.040.40
Standard Applicability:This standard applies to blood gas exchangers (oxygenators) used in cardiopulmonary diversion systems and to heat exchangers that are an integral part of an oxygenator. This standard specifies requirements for sterile, single-use blood gas exchangers (oxygenators) for use in cardiopulmonary bypass systems. This standard does not apply to implantable oxygenators, liquid oxygenators, extracorporeal circulation tubing, separated heat exchangers, and separated accessories. This standard replaces YY 0604-2007 “Cardiovascular implants and artificial organs blood gas exchanger (oxygenator)”.
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