YY/T 1416.4-2016 English PDF (YYT1416.4-2016)

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YY/T 1416.4-2016: Test method for additive in single-use containers for human venous blood specimen collection--Part 4: Fluoride
YY/T 1416.4-2016
Test method for additive in single-use containers for human venous blood specimen collection--Part 4. Fluoride
ICS 11.120.20
C48
People's Republic of China Pharmaceutical Industry Standard
Disposable human blood sample collection container
Method for determination of additive doses. Part 4. Fluoride
specimencolection-Part 4.Fluoride
Published on.2016-07-29
2017-06-01 Implementation
The State Food and Drug Administration issued
Foreword
YY/T 1416 "Determination of additive content in a single-use human venous blood sample collection container" consists of the following parts.
--- Part 1. ethylenediaminetetraacetic acid (EDTA) salt;
--- Part 2. Sodium citrate;
---Part 3. Heparin;
--- Part 4. Fluoride.
This section is Part 4 of YY/T 1416.
This section 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 involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This section was proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This section was drafted by. Shandong Provincial Medical Device Product Quality Inspection Center, Guangzhou Yangpu Medical Technology Co., Ltd.
The main drafters of this section. Xu Kai, Zhang Limei, Sun Bangfu.
introduction
One-time use of human venous blood sample collection containers (abbreviation. blood collection tube) is matched with one-time use of sterile venous blood sample collection needles.
Blood samples were collected for clinical testing. The use of blood collection tubes containing different additives or additives is different. Fluoride is a type of glycolysis.
The preparations have a good effect of preventing the degradation of blood glucose and are excellent preservatives for blood glucose detection, and are generally used for blood glucose detection.
YY 0314 only gives the concentration ranges of fluoride/oxalate, fluoride/EDTA, and fluoride/heparin. This section gives the corresponding
A method of measuring the amount of additives.
This part of YY/T 1416 recommends the use of ion chromatography to determine the amount of additives in a single blood collection tube to facilitate the quality control of blood collection tubes.
Other methodologically validated assays can also be used.
Disposable human blood sample collection container
Method for determination of additive doses. Part 4. Fluoride
1 Scope
This part of YY/T 1416 specifies the one-time use of human venous blood sample collection capacity for the determination of fluoride in additives by ion chromatography.
Apparatus (abbreviation. blood collection tube) Test method for the amount of additives.
This section applies to blood collection tubes containing fluoride, oxalate, EDTA, and fluoride/heparin as additives.
The amount of oxalate, oxalate and EDTA, for blood collection tubes containing fluoride/heparin additives, the amount of heparin may be in accordance with YY/T 1416.3
The blue spectrophotometric method was used for the determination.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
YY/T 1416.3 Determination of the amount of additives in human venous blood sample collection containers for one-time use Part 3. Heparin
3 Test section
3.1 Test principle
This section uses ion chromatography to determine the fluoride ion, EDTA ion, and oxalate ion in the blood collection tube. The retention time is used for qualitative analysis.
The peak area was quantified and the fluoride, EDTA and oxalate ions in the blood collection tube were determined.
3.2 Instruments and reagents
Unless otherwise specified, the reagents used should be analytically pure, and the test water should meet the requirements for secondary water specified in GB/T 6682.
a) Instruments and equipment. ion chromatography;
b) Chromatographic conditions. column. AS-11HC1); eluent. 30 mmol/L KOH solution; flow rate. 1.00 mL/min; column temperature.
30 °C; suppressor current. 75mA;
1) Other suitable model columns can also be used. The chromatographic conditions must be determined experimentally.
c) fluoride ion standard solution. commercially available, concentration of 1000mg/L;
d) EDTA ion standard solution [ρ(EDTA2-)=1000mg/L]. Weigh 0.1280g disodium EDTA accurately
Hydrate (EDTA-Na2 · 2H2O), water to volume to 100mL;
e) Oxalate standard solution [ρ(C2O42-)=1000mg/L]. Weigh 0.1522g Na2C2O4 accurately and use it to remove water
Capacity to 100mL.
Note. The concentration of all standard solutions is the mass concentration of ions, and the calculation result must be converted into the mass concentration of additives.
3.3 Test procedure
3.3.1 Drawing of Standard Curve
Precisely take 4 mL of each of the standard solution of fluoride ion, EDTA ion, or oxalate ion in 3.2, and dilute to 100 mL with water to obtain the concentration.
About 40mg/L mixed standard solution. Measure 0.5 mL, 1.0 mL, 2.0 mL, 3.0 mL, and 4.0 mL of the mixed standard solution, respectively.
5.0 mL, respectively, to 10 mL, to obtain a concentration of about 2 mg/L, 4 mg/L, 8 mg/L, 12 mg/L, 16 mg/L, 20 mg/L
Combined standard solution, direct injection analysis. Use the concentration ρ (mg/L) as the abscissa and the peak area as the ordinate to draw a standard curve, and find the regression
equation.
Note. Since both EDTA and oxalic acid are weak acids, ionization is incomplete at higher concentrations. Therefore, regression of the standard curve using a first-order function may cause the correlation coefficient to be not
In the high case, the concentration range of the standard solution may be adjusted as appropriate or a quadratic function regression equation may be used.
3.3.2 Determination of Samples
Take 1 blood collection tube, add water to nominal capacity, vortex and collect it in a suitable volumetric flask, and then add the nominal capacity of water again and again.
After washing, collect the washing solution into the same volumetric flask, dilute it with water to the mark, and shake it to make the sample dissolved within the standard curve.
Liquid, injection analysis. Find out the fluoride ion, EDTA ion, or oxalate ion in each blood collection tube on the standard curve or using the regression equation.
The concentration value is then converted into the quality of the additive.
Note. When the sample is measured, it is calculated in advance according to the labeled amount of the additive so that the concentration of each ion in the sample is within the range of the standard curve concentration. In addition, when
When heparin is contained in the product, heparin is preferably removed from the sample because heparin damages the column. However, because the heparin concentration has been
A relatively low level, as long as it is not measured in large quantities over a long period of time, the effect on the column will not be great, and it will add to the sample except for heparin.
Additive content determination has no effect.
Take another blood collection tube and repeat the above procedure.
4 Test report
The test report should include at least the following.
a) Identification of test samples;
b) the standard number of this section;
c) test results;
d) test date;
e) Test personnel.