YY 0604-2007 (English Version) PDF

Scope: This standard specifies the requirements for sterile, disposable extracorporeal circulation blood gas exchangers (oxygenators) (hereinafter referred to as oxygenators), which are used to supply oxygen to human blood and remove carbon dioxide from the blood. This standard also applies For heat exchangers that are an integral part of the oxygenator, this standard does not apply to: 　——Implantable oxygenator; 　——Liquid oxygenator; 　——Extracorporeal circulation pipeline; 　——Separate heat exchanger; 　——Separate accessories

YY 0604-2007 Referenced Document

GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 14437-1997 Single sampling procedures and tables by attributes for product quality audit
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 1962.2-2001 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
GB/T 2828.1 Inspection procedure by count sampling part 1: Lot by lot inspection sampling plan retrieved by acceptance quality limit (AQL)*， 2013-02-15 Update
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products

2018 YY 0604-2016 Cardiopulmonary bypass system blood gas exchanger (oxygenator)
2007 YY 0604-2007 Cardiovascular implants and artificial organs.Blood-gas exchangers(oxygenators)