YY 0948-2015: Translated English of Chinese Standard. YY0948-2015: Cardiopulmonary bypass systems - Arteriovenous cannula for single use
https://www.chinesestandard.net, 23 apr 2018 - 12 pagine
This standard specifies the classification and structure, requirements, testing methods, marks, labels, instructions for use, packaging, transportation and storage of aseptic disposable arteriovenous cannula (hereinafter referred to as Arteriovenous cannula). This standard is suitable for arteriovenous cannula supporting cardiopulmonary bypass system. It is used for drainage or perfusion of blood during direct vision cardiac operation of cardiopulmonary bypass (CPB).
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3 Classification and structure
5 Testing method
6 Marks labels instructions for use
7 Packaging transportation storage
according to GB/T arterial cannula arteriovenous cannula aseptic atmospheric pressure Bending resistance test Biological evaluation biological hazard Biological performance blank control solution blood Cardiopulmonary bypass systems Chemical performance Classification and structure conform connection of arteriovenous Connection strength Corrosion resistance equipment for medical ethylene oxide Evaporation residue exceed following marks glass flask Heavy metal individual package injection equipment labels Leakage test line Marking line Marking line Marking Medical Device methods for infusion methods GB/T model specification number of particles observe carefully oxygenated Particulate pollution perfuses period of validity Physical performance plug Product external package Product name Production batch number pyrogen Reducing substance referenced document requirements residue test Test routine control seal all outlets specifications in 4.2.1 standard sterilization GB sterilization process Temperature adaptability Test length Test methods test solution test Take test Test according Tube body UV absorbance vacuum pump Validation and routine validity period venous cannula words or marks YY/T