YY/T 1465.1-2016: Immunogenic Evaluation Method of Medical Devices - Part 1: T Lymphocyte Transformation Test in Vitro

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Scope

This Part gives the MTT method and CFSE method for the T lymphocyte
transformation test in vitro; it is applicable to evaluate the effect of medical
devices/materials on the T lymphocyte immune function.

Basic Data

Standard ID	YY/T 1465.1-2016 (YY/T1465.1-2016)
Description (Translated English)	Immunogenic Evaluation Method of Medical Devices - Part 1: T Lymphocyte Transformation Test in Vitro
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	7,795
Date of Issue	2016-01-26
Date of Implementation	2017-01-01
Quoted Standard	GB/T 16886.1; GB/T 16886.2; GB/T 16886.12; GB/T 16886.20
Regulation (derived from)	China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the MTT assay and CFSE method for in vitro T lymphocyte transformation assays, which are useful for assessing the effect of medical devices/materials on T lymphocyte immune function.