YY/T 1416.4-2016: Test method for additive in single-use containers for human venous blood specimen collection--Part 4: Fluoride

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Scope

This Part of YY/T 1416 specifies the experiment method of using ion chromatography
method to determine the amounts of additives in single-use containers for human
venous blood specimen collection (abbreviated as blood-collecting vessel, whose
additives have fluoride).
This Part applies to the blood-collecting vessels whose additives are fluoride/oxalate,
fluoride/EDTA and fluoride/heparin. They can separately determine the amount of
fluoride, oxalate and EDTA. For the blood-collecting vessel which contain the additive
of fluoride/heparin, the amount of heparin can be determined by the methylene blue
spectrophotometric method in YY/T 1416.3.

Basic Data

Standard ID	YY/T 1416.4-2016 (YY/T1416.4-2016)
Description (Translated English)	Test method for additive in single-use containers for human venous blood specimen collection--Part 4: Fluoride
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C48
Word Count Estimation	5,568
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Quoted Standard	GB/T 6682; YY/T 1416.3
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the method for the determination of the amount of fluoride in the additive used in the determination of the fluoride in the additive using the intravenous blood collection container (abbreviation: blood collection tube). This standard applies to the addition of fluoride/oxalate, fluoride/EDTA, fluoride/heparin blood collection tube, can be measured fluoride, oxalate and EDTA, for fluoride/heparin additives containing blood vessels, The amount of heparin can be YY/T 1416.3 in the methylene blue spectrophotometric method for determination.