YY/T 1416.3-2016 English PDF (YYT1416.3-2016)

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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
YY/T 1416.3-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Test method for additive in single-use containers
for human venous blood specimen collection –
Part 3. Heparin
ISSUED ON. JULY 29, 2016
IMPLEMENTED ON. JUNE 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3 
Introduction .. 4 
1 Scope .. 5 
2 Normative references . 5 
3 Test section . 5 
4 Test report . 7 
Introduction
Single-use containers for human venous blood specimen collection (abbreviated as
blood-collecting vessel) and single-use needle for sterile venous blood specimen
collection shall be used together. Venous blood samples shall be collected for clinical
test. The use of blood-collecting vessels which contain different additives or addenda
are different. Heparin is widely distributed in almost all tissues, such as lung, liver and
spleen, and in the granule of mast cells and basophilic granulocytes around blood
vessels. Heparin can enhance the inactivation from antithrombin III (AT-III) to serine
proteases, therefore, it can prevent the formation of thrombin and prevent several kinds
of anticoagulation such as platelet aggregation. Although heparin can maintain the
natural morphology of red blood cells, however, it often causes leukocyte aggregation,
and when smears are used for Roche staining, blue background can be produced.
Therefore, heparin anticoagulation is not suitable for general whole-hematology
examinations. Heparin is the ideal anticoagulant for red-blood-cell permeability test.
YY 0314 only gives the concentration range of heparin sodium / heparin lithium. This
part of YY/T 1416 gives the method for determining the amount of each additive.
This section recommends methylene blue spectrophotometric method to determine the
amount of additive “heparin sodium / heparin lithium” in single blood-collecting vessel,
so as to facilitate the quality control of single-use containers for human venous blood
specimen collection. Other methods of measurement may also be used, but
methodological confirmation shall be required.
Test method for additive in single-use containers
for human venous blood specimen collection –
Part 3. Heparin
1 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.
2 Normative references
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this standard.
GB/T6682 Water for analytical laboratory use - Specification and test method
3 Test section
3.1 Test principle
This Part is the experiment method of using methylene blue spectrophotometric
method to determine the potency of heparin lithium / heparin sodium in blood-collecting
vessel; it uses heparin to react with the methylene blue solution to conduct the fading
reaction; and it determines the content of heparin lithium / heparin sodium by the
relation that the decrease in absorbance is proportional to the concentration of heparin
in solution.
3.2 Instruments and reagents
Unless otherwise specified, the reagents used shall be analytically pure; the test water
shall meet the requirements for Grade-2 water specified in GB/T 6682.