YY 0580-2011 (English Version) PDF

Scope: This standard specifies the requirements for sterile, disposable arterial line blood filters (hereinafter referred to as filters). This device is intended to be used to filter microemboli, debris, and microorganisms from human blood during cardiopulmonary bypass surgery. Blood clots, microbubbles and other potentially hazardous substances.

YY 0580-2011 Referenced Document

GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*， 2023-09-08 Update
GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
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YY 0604 Cardiopulmonary bypass system blood gas exchanger (oxygenator)*， 2018-01-01 Update
YY/T 0287 Medical devices.Quality management systems.Requirements for regulatory purposes*， 2017-01-19 Update

2011 YY 0580-2011 Cardiovascular implants and artificial organs.Cardiopulmonary bypass systems.Arterial blood line filters
2005 YY 0580-2005 Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial line blood filters