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YY/T 1416.1-2016 English PDF (YY/T1416.1-2016)

YY/T 1416.1-2016 English PDF (YY/T1416.1-2016)

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YY/T 1416.1-2016: Test method for additive in single-use containers for human venous blood specimen collection. Part 1: Ethylene diamine tetraacetic acid (EDTA) salt

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Scope

In this part of YY/T 1416 specifies the method for determining the volume of
EDTA salt additive in a single-use container for human venous blood specimen
collection (hereinafter referred to as "collection container").
This part applies to single-use containers for human venous blood specimen
collection which only contains the additive of ethylene diamine tetraacetic acid
(EDTA) salt.

Basic Data

Standard ID YY/T 1416.1-2016 (YY/T1416.1-2016)
Description (Translated English) Test method for additive in single-use containers for human venous blood specimen collection. Part 1: Ethylene diamine tetraacetic acid (EDTA) salt
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 7,714
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Quoted Standard GB/T 6682
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the method for the determination of the amount of ethylenediaminetetraacetic acid (EDTA) added in the disposable venous blood collection container (hereinafter referred to as "blood collection tube"). This standard applies to single-use intravenous blood sample collection containers containing only ethylenediaminetetraacetic acid (EDTA) salt additives.


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