YY/T 1465.1-2016
Immunogenic evaluation method of medical devices.Part 1: T Lymphocyte transformation test in vitro (English Version)

Standard No.

YY/T 1465.1-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 1465.1-2016

Scope

This section provides the MTT method and CFSE method for in vitro T lymphocyte transformation tests, which are suitable for evaluating the impact of medical devices/materials on the immune function of T lymphocytes.

YY/T 1465.1-2016 Referenced Document

• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices

YY/T 1465.1-2016 history

• 2016 YY/T 1465.1-2016 Immunogenic evaluation method of medical devices.Part 1: T Lymphocyte transformation test in vitro