This part specifies the classification and naming, requirements, test methods, inspection rules, marking, packaging, transportation and storage of diluents for blood cell analyzers. YY/T 0456.3-2003 Reagents for blood cell analyzers Part 3: Dilutions YY/T0456.3-2003 Standard download decompression password: www.bzxz.net

YY/T0467 "Reagents for blood cell analyzers" is divided into 3 parts: - Part 1: Cleaning solution;
Part 2: Hemolytic agent;
- Part 3: Diluent.
This part is Part 3 of YY/T0467: Diluent. YY/T0456.3--2003
This part is applicable to diluents for blood cell analyzers. This product is an electrolyte balance solution with acid-base buffering effect, appropriate ionic strength and conductivity, used as a diluent for human blood cell counting, volume measurement and white blood cell classification counting. As a special reagent for designated blood cell analyzers, the method of use of this product should comply with the method specified in the manual of the designated blood cell analyzer. Appendix A of this part is a normative appendix.
This part is proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Laboratory and In Vitro Diagnostic System. Drafting organizations of this part: Beijing Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration, Jiangxi Tekang Technology Co., Ltd.
Main drafters of this part: Liu Xiaojun, Zhou Honghua, Zhang Zhaoyuan, Yan Xiao, Zhang Hong. 1 Scope
YY/T0456.3—2003
Reagents for blood cell analyzers Part 3: Diluents This part specifies the classification and naming, requirements, test methods, inspection rules, marking, packaging, transportation and storage of diluents for blood cell analyzers.
This part applies to diluents for blood cell analyzers using the electrical impedance method. 2 Normative references
The clauses in the following documents constitute the clauses of this part through reference in this part of YY/T0467. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to an agreement based on this part are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this part.
GB/T191-2000 Pictorial marking for packaging, storage and transportation GB/T9724--1988 General rules for determination of pH value of chemical reagents 3 Classification and naming
3.1 Naming of diluents
Diluents
3.2 Classification
Product model
Diluents
Product model
The specific model of the blood cell analyzer to which the diluent is applicable shall be clearly stated in the manufacturer's registered product standard. 4 Requirements
4.1 Appearance
The diluent shall be a colorless and transparent liquid without precipitation, particles or floccules. 4.2 External marking
The external marking of the diluent product shall comply with the requirements of 7.1. 4.3 Net content
The net content of the diluent shall comply with the provisions of Table 1.
Table 1 Net content requirements
1 ≤V≤20 L
Maximum allowable negative deviation
The pH value of the diluent at (25℃±1℃) shall not exceed ±0.20 of the nominal value. The nominal value shall be clearly specified in the manufacturer's registered product standard according to the design requirements of the applicable hematology analyzer. 4.5 Conductivity
The conductivity (p) value of the diluent at (25℃±1℃) shall not exceed ±0.50mS/cm of the nominal value. The nominal value shall be clearly specified in the manufacturer's registered product standard according to the design requirements of the applicable hematology analyzer. 1
YY/T0456.3—2003
4.6 Osmotic concentration
The osmotic concentration value of the diluent shall not exceed ±10 mmol/L±10mOsm/kg of the nominal value). The nominal value shall be clearly specified in the manufacturer's registered product standard according to the design requirements of the applicable blood cell analyzer. 4.7 Blank value
When using a blood cell analyzer for determination, the measurement results are white blood cell count (WBC) <0.3×10°/L, red blood cell count (RBC) <0.05×1012 /L, platelet count (PLT) ≤10×10°/I, and hemoglobin content (HGB) ≤2g/I. 4.8 Accuracy
4.8.1 Original diluent: The relative deviation of white blood cell (WBC) count shall not exceed ±10%, the relative deviation of red blood cell (RBC) count shall not exceed 5%, the relative deviation of hemoglobin (HGB) content shall not exceed ±5%, the relative deviation of platelet (PLT) count shall not exceed ±15%, and the relative deviation of mean corpuscular volume (MCV) shall not exceed ±5%. 4.8.2 Alternative diluent: White blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (HGB) content, platelet (PLT) count, mean corpuscular volume (MCV) should all fall within the range of X ± 2SD of the results obtained by the original reagent. 4.9 Colony count
Microbial count <50CFU/ml.
4.10 Batch difference
pH value batch difference should be ≤0.20; conductivity batch difference should be ≤0.50mS/cm; osmotic concentration batch difference should be ≤10mmol/L (10 mOsm/kg).
4.11 Stability
The diluent should have a specified validity period. Take the retained sample within three months after the expiration date to test 4.1, 4.4~4.9. The results should meet the requirements of each item.
5 Test method
5.1 Appearance inspection
After the dilution is shaken, take out an appropriate amount and put it into a colorimetric tube. Visually inspect it against light. It should meet the requirements of 4.1. 5.2 External mark inspection
Visually inspect the external mark of the product packaging. It should meet the requirements of 4.2. 5.3 Net content determination
Use an applicable general measuring tool to measure or weigh the net weight and calculate the volume according to its density. The result should meet the requirements of 4.3. 5. 4 pH determination
Take an appropriate amount of dilution and determine its pH value according to the method specified in GB/T9724-1988. Measure it three times in a row, and the average value should meet the requirements of 4.4.
5.5 Conductivity determination
Adjust and calibrate the conductivity meter according to the instrument manual, and then determine the conductivity value of the dilution at 25℃±1℃ according to the steps and methods specified in the operating manual of the conductivity meter. The average value of the three consecutive measurements shall meet the requirements of 4.5. 5.6 Osmotic concentration determination
Use a calibrated freezing point osmotic concentration meter to determine the osmotic concentration value of the diluent according to the steps and methods specified in the instrument operating manual. The average value of the three consecutive measurements shall meet the requirements of 4.6. 5.7 Blank value determination
When using a fully automatic or semi-automatic blood cell analyzer, first empty the original reagents inside the analyzer, introduce the diluent to be tested, and perform a blank measurement. The maximum value of the results obtained for each indicator shall meet the requirements of 4.7 after three consecutive measurements. 5.8 Accuracy determination
5.8.1 Original diluent: According to the provisions of the blood cell analyzer operating manual, use fixed-value blood as a specimen and measure it on the analyzer with the diluent to be tested. Measure three times in a row and take the average value of the measurement results. The relative deviation between the mean value and the fixed blood label value shall comply with 2 of 4.8.1.
YY/T0456.3--2003
7 Marking and labeling
7.1 The marking on the outer packaging of the diluent product shall include at least the following contents: a)
Product name and model;
Main ingredients and net content;
Product use and applicable instruments;
Product registration number;
Implementation product standard number;Www.bzxZ.net
Precautions;
Production batch number and validity period;
Manufacturer name and address;
Product packaging, storage, transportation and graphic marking shall comply with the relevant requirements of GB/T191-2000. 7.2 The outer packaging box of the diluent product should be accompanied by a certificate of conformity, which should at least include the following: product name and model;
production batch number;
inspector code;
"Qualified".
8 Packaging, transportation, purchase and storage
The diluent should be packaged in a suitable container and sealed with a cover. 8.1
8.2 The product packaging should meet the requirements specified in the contract, ensuring that the product packaging is not damaged during long-distance transportation and that the reagents do not leak. 8.3 The product should be stored under the specified conditions. 4
A.1 Preparation of culture medium
A.1.1 Raw materials
For every 1000mL of culture medium, the following should be taken:
Beef extract: 3g;
Peptone: 10g;
Sodium chloride: 5g;
Agar: 15g~20g;
Water: 1 000mL.
A.1.2 Preparation
Appendix A
(Normative Appendix)
Method for determination of colony count
YY/T0456.3—2003
A.1.2.1 Dissolve the weighed raw materials in a conical flask with water, filter with 2 to 3 layers of gauze to make up for the lost water. A.1.2.2 Use 1 mol/L sodium hydroxide or hydrochloric acid solution to adjust the pH value of the culture medium to between 7.0 and 7.2, then plug the bottle mouth with a cotton plug and seal it with kraft paper. If it cannot be sterilized in time, it should be stored in a refrigerator at 2℃ to 8℃. A.2 Sterilization
Plug the sampling tube with a rubber plug, then wrap all the sampling tubes with a layer of kraft paper and tie them into a bundle with a thin rope. Wrap the culture blood, pipette and other required items with kraft paper respectively. Then sterilize it at 121℃ for 20 minutes together with the prepared culture medium. A.3 Sampling
Bring alcohol lamps, sampling tubes and other items. Light the alcohol lamp, open the lid of the diluent barrel, bring the alcohol lamp flame close to the barrel mouth, pour 5mL~10ml of diluent from the diluent barrel into the sampling tube, and use the flame to rotate the sampling tube mouth and rubber stopper for 1s~2s, and finally plug the tube mouth. A.4 Inoculation
A.4.1 Before inoculation, soak your hands with 0.05%~0.1% of Sanisol, then put the culture blood, culture medium, sample, pipette, etc. into the clean bench, and mark each culture dish accordingly. Two parallel control dishes are required for each sample. And make a blank control. A.4.2 Add sample: use a pipette to absorb 1mL of sample and inject it into the corresponding culture dish. No sample is added to the blank control. A.4.3 Add ordinary agar culture medium: add 15mL~20mI. of ordinary agar culture medium (about 45℃) to culture III, preferably just covering the bottom of the dish. Add the blank control dish first, and immediately cover the dish after adding other samples. Gently shake the dish to mix the sample with the agar.
A.4.4 After all the ordinary agar culture media have cooled and solidified, wrap the culture III with kraft paper again, write the inoculation date on the outside of the paper, and invert it in a constant temperature incubator at 35℃～37℃ for culture. A.5 Result recording
Observe every 24h, record the number of colonies grown after 24h and 48h, and the size, shape, color, etc. of the colonies, and finally record the number of colonies after 48h.
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