YY/T 1492-2016 Cardiopulmonary bypass systems—General requirement for coating products

GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals YY 0580-2011 Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters YY 0603-2015 Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems(with/without filter)and soft venous reservoir bags YY 0604-2016 Cardiopulmonary bypass systems—Blood-gas exchangers(oxygenators) YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging YY/T 0730-2009 Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO) GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices

ISO 11658:2012