YY/T 1849-2022 Recombinant collagen protein

中华人民共和国药典 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices 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 YY/T 1453-2016 Tissue engineering medical device products—Methods for determination of type Ⅰ collagen YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) YY/T 1465.3-2016 Immunogenic evaluation method of medical devices—Part 3:Plaque forming cells assay—Agar gel solid-phase method YY/T 1465.4-2017 Immunogenic evaluation method of medical devices—Part 4:Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes—Ex-vivo method YY/T 1465.5-2016 Immunogenic evaluation method of medical devices—Part 5:Determination of α-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody YY/T 1465.6-2019 Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry YY/T 1465.7-2021 Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry YY/T 1805.2-2021 Tissue engineering medical device products—Collagen protein—Part 2:Determination of molecular weight of type Ⅰ collagen—Sodium dodecyl sulfate polyacrylamide gel electrophoresis YY/T 1805.3-2022 Tissue engineering medical device products—Collagen protein—Part 3:Quantification of collagen based on marker peptide detection—Liquid chromatography-mass spectrometry 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