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YY/T 1416.2-2016 (YYT1416.2-2016)

YY/T 1416.2-2016_English: PDF (YYT 1416.2-2016, YYT1416.2-2016)
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YY/T 1416.2-2016English125 Add to Cart 0--9 seconds. Auto-delivery Test method for additive in single-use containers for human venous blood specimen collection. Part 2-Sodium citrate Valid YY/T 1416.2-2016

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 & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.120.20
Word Count Estimation 6,661
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 6682
Drafting Organization Shandong Province medical equipment product quality inspection center
Administrative Organization National Standard Committee on Medical Infusion Equipment
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Proposing organization State Administration of Food and Drug Administration
Issuing agency(ies) State Administration of 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.

Standards related to: YY/T 1416.2-2016

YY/T 1416.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 31
Test method for additive in single use containers
for human venous blood specimen collection –
Part 2. Sodium citrate
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3 
Introduction .. 4 
1 Scope .. 5 
2 Normative references . 5 
3 Osmotic pressure method .. 5 
4 Titration method . 7 
5 Test report . 8 
Test method for additive in single use containers
for human venous blood specimen collection –
Part 2. Sodium citrate
1 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.
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/T 6682 Water for analytical laboratory use - Specification and test methods
Pharmacopoeia of the People's Republic of China (2010) - Volume II
3 Osmotic pressure method
3.1 Test principle
The osmotic pressure method is suitable for the determination of the concentration of
the sodium citrate in the form of non-buffered dihydrate in single-use blood-collecting
vessel. Use the sodium-citrate standard stock solution to prepare a series of standard
solutions. Use the freezing point osmometer to measure the osmotic-pressure value
of each standard-concentration solution; draw the standard curve (linear) between the
concentration and the osmotic pressure. Use the same method to measure the osmotic
pressure of the sodium citrate solution in blood-collecting vessel. Use the standard
curve to look up or use the linear regression equation to calculate the sodium-citrate’s
concentration corresponding to the osmotic pressure of the sample.
3.2 Instruments and reagents
4 Titration method
4.1 Test principle
Use the perchloric acid titrant whose concentration is known to titrate the content of
sodium citrate in each blood-collecting vessel; use crystal violet as the indicator; titrate
it until the color of the solution changes from violet to green.
4.2 Instruments and Reagents
4.2.1 Instruments
Main instruments include.
a) Magnetic stirrer;
b) Electronic balance with the accuracy of 0. 1 mg;
c) Closed automatic burette (acid).
4.2.2 Reagents
Unless otherwise specified, the reagents used should be the analytically pure. The test
water shall meet the requirements for Grade-2 water specified in GB/T 6682. Wherein.
a) Glacial acetic acid. analytically pure. The purity shall be ≥ 99%, CAS 64-19-7;
b) Crystal violet. weigh 1.0 g of biological stain “crystal violet”; add 100 mL of glacial
acetic acid to dissolve it; that is the crystal violet;
c) Perchloric acid titrant [c(HClO4) = 0.1 mol/L]. use the commercially available
certified product; or it can be prepared or calibrated by the “VF perchloric acid
titrant” in Appendix X of the “Pharmacopoeia of the People's Republic of China
(2010) - Volume II”; place it in the brown glass bottle; keep it sealed.
d) Perchloric acid titrant [c(HClO4) = 0.1 mol/L]. take 0.1 mol/L perchloric acid titrant;
prepare it by diluting it with the anhydrous acetic acid; and calibrate its
concentration.
4.3 Test procedures
Take 1 blood-collecting vessel; use a small amount of water to rinse the vessel’s wall
and plug, for 3 times separately; collect all the rinsed solution and transfer it to a
erlenmeyer flask of 250 mL. Heat the erlenmeyer flask until the solution is evaporated
...