This standard specifies the requirements for the evaluation of alginate gel fixation or microencapsulation, including alginate gel fixation or microencapsulation, the performance and investigation of microcapsules or microbeads, and the biological phase of alginate gel. Capacity inspection. This standard applies to the evaluation of alginate gel fixation or microencapsulation.
YY/T 1574-2017 Referenced Document
GB 16352 Standards for γ-rays radiation sterilization of disposable medical appliances
GB 18278.1 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
GB 18281.1 Sterilization of health care products.Biological indicators.Part 1:General requirements
GB 18281.2 Biological indicators for sterilization of healthcare products - Part 2: Biological indicators for ethylene oxide sterilization
GB 18281.3 Biological indicators for sterilization of healthcare products - Part 3: Biological indicators for moist heat sterilization
GB 18281.4 Biological indicators for sterilization of healthcare products - Part 4: Biological indicators for dry heat sterilization
GB 18281.5 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam
GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
YY/T 0606.8 Tissue engineered medical products.Part 8:Alginate
YY/T 1574-2017 history
2017YY/T 1574-2017 Tissue engineering medical device products.Standard guide for immobilization or encapsulation in alginate gels