YY/T 1416.1-2016 English PDF (YYT1416.1-2016)

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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
YY/T 1416.1-2016
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 1. Ethylene diamine tetraacetic acid (EDTA) salt
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 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
Appendix A (Informative) Preparation of calcium titration solution .. 10
Foreword
YY/T 1416.1-2016 “Test method for additive in single-use containers for human
venous blood specimen collection” is composed of the following parts.
- Part 1. Ethylene diamine tetraacetic acid (EDTA) salt;
- Part 2. Sodium citrate;
..
This part is Part 1 of YY/T 1416.1-2016.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may be patented. The
issuing agency of this document shall not be responsible for the identification
of these patents.
This part was proposed by China Food and Drug Administration.
This part shall be under the jurisdiction of National Technical Committee for
Standardization of Medical Infusion Instruments (SAC/TC 106).
The drafting organizations of this part. Shandong Quality Inspection Center of
Medical Device Product, Beidi Medical Instruments (Shanghai) Co., Ltd,
Shandong Xinhua Ande Medical products Co., Ltd., Shengguang Medical
products Co., Ltd.
The main drafters of this part. Qin Yang, Zhou Xiuhua, Meng Qingsong, Qiao
Xiaohong, Liu Ye.
Test method for additive in single-use containers for
human venous blood specimen collection - Part 1.
Ethylene diamine tetraacetic acid (EDTA) salt
1 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.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
Pharmacopoeia of the People's Republic of China, 2nd part, 2010 edition
3 Osmotic pressure method
3.1 Test principle
Prepare a series of standard solutions with EDTA salt standard reserve solution.
Measure the osmotic pressure of each standard concentration solution by
freezing point osmosimeter. Draw a standard curve (linear) of the osmotic
pressure. Measure by the same method the osmotic pressure of EDTA salt
solution in the blood collection tube where the nominal capacity is reached by
adding water. Find from the standard curve or calculate by linear regression
equation the concentration of ethylene diamine tetraacetic acid (EDTA) salt
corresponding to the osmotic pressure of the sample.
3.2 Instruments and reagents
3.2.1 Instrument
Instruments for osmotic pressure method include.
a) Freezing point osmometer;
b) Electronic balance with precision of 0.1mg.
3.2.2 Reagent
Unless otherwise specified, the reagent used shall be analytical pure, and the
water used shall conform to the requirements of the 2nd class water specified in
GB/T 6682, of which.
a) Ethylene diamine tetraacetic acid disodium dishydrate (EDTA-Na2·2H2O).
analytical purity≥99.0%;
b) Ethylene diamine tetraacetic acid dipotassium dihydrate (EDTA-
K2·2H2O). analytical purity≥99.0%;
c) Anhydrous ethylene diamine tetraacetic acid tripotassium (EDTA-K3).
analytical purity≥99.0%.
3.3 Test steps
3.3.1 Drawing of standard curve
Accurately weigh appropriate amount of ethylene diamine tetraacetic acid
(EDTA) salt [a), b) or c) in 3.2.2] corresponding to the additive to be tested in
single-use blood collection tube. Add water to dissolve and dilute to a mass
concentration of EDTA salt at about 10 mg/mL. Thus, the standard reserve
solution is prepared. Accurately measure appropriate amount of the reserve
solution respectively. Add water to dilute to a series of standard solution with
the concentration of EDTA salt at 0.5mg/ mL~4.0 mg/mL. Determine the
osmotic pressure of each concentration solution according to the method of the
osmotic pressure molar concentration specified in the second part IX G of the
Pharmacopoeia of the People's Republic of China 2010 edition. Draw a
standard curve with the concentration C (mg/mL) as ordinate and the osmotic
pressure value X (mOsm/kg) as abscissa. Also make the regression equation.
3.3.2 Determination of sample solution
Take 3 EDTA blood collectors, add water of nominal volume with precision,
shake fully until anticoagulant is dissolved. Respectively determine the osmotic
pressure of the 3 EDTA blood collectors by the method of osmotic pressure
specified in the second part IX G of the Pharmacopoeia of the People's
Republic of China. Find on the standard curve or calculate by regression