YY/T 1416.2-2016: Test method for additive in single-use containers for human venous blood specimen collection. Part 2-Sodium citrate

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Scope

This Part of YY/T 1416 specifies the method for determining the amount of additive
“sodium citrate” in single-use containers for human venous blood specimen collection
(hereafter referred to as blood-collecting vessel).
This Part applies to the determination of the sodium citrate in the form of non-buffered
dihydrate in single-use containers for human venous blood specimen collection and
the determination of the sodium citrate in buffered sodium-citrate additive.

Basic Data

Standard ID	YY/T 1416.2-2016 (YY/T1416.2-2016)
Description (Translated English)	Test method for additive in single-use containers for human venous blood specimen collection. Part 2-Sodium citrate
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.120.20
Word Count Estimation	6,686
Date of Issue	2016-01-26
Date of Implementation	2017-01-01
Quoted Standard	GB/T 6682
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 method for the determination of the amount of sodium citrate in the disposable venous blood collection container (hereinafter referred to as "blood collection tube"). This standard is applicable to the determination of sodium citrate in sodium citrate and buffered sodium citrate additives in the form of unbuffered dihydrate in a collection of human venous blood sampling containers.