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 1465.5-2016 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

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 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements