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YY/T 1416.3-2016 English PDF (YY/T1416.3-2016)

YY/T 1416.3-2016 English PDF (YY/T1416.3-2016)

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YY/T 1416.3-2016: Test method for additive in single-use containers for human venous blood specimen collection--Part 3: Heparin

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Scope

This Part of YY/T 1416 specifies the experiment method of using methylene blue
spectrophotometric method to determine the amount of additive “heparin” in single-use
containers for human venous blood specimen collection (abbreviated as blood-
collecting vessel).
This Part applies to the blood-collecting vessel whose additive is heparin lithium /
heparin sodium.

Basic Data

Standard ID YY/T 1416.3-2016 (YY/T1416.3-2016)
Description (Translated English) Test method for additive in single-use containers for human venous blood specimen collection--Part 3: Heparin
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Word Count Estimation 5,564
Date of Issue 2016-07-29
Date of Implementation 2017-06-01
Quoted Standard GB/T 6682
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 heparin in the disposable venous blood sample collection vessel (abbreviation: blood collection tube) by methylene blue spectrophotometry. This standard applies to the additive for heparin lithium/heparin sodium blood collection tube.


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