YY/T 1465.2-2016: Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)

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Scope

This Part gives the method using the enzyme-linked immunosorbent assay to
determine the levels of serum immunoglobulin and complement component; it is
suitable for the evaluation of immune response products induced by medical
devices/materials.

Basic Data

Standard ID	YY/T 1465.2-2016 (YY/T1465.2-2016)
Description (Translated English)	Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	7,774
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 methods for the determination of serum immunoglobulins and complement components by enzyme-linked immunosorbent assay (ELISA), which is suitable for the evaluation of immune response products produced by medical devices/materials.