YY/T 0456.2-2003 Reagents for blood cell analyzers Part 2: Hemolytic agents
Some standard content:
YY/T0456 "Reagents for blood cell analyzers" is divided into 3 parts: Part 1: Cleaning solution; Part 2: Hemolytic agent; Part 3: Dilution solution. This part is Part 2 of YY/T0456: Hemolytic agent. YY/T 0456.2---2003 This part applies to hemolytic agents for blood cell analyzers. This part is formulated on the basis of quality inspection and a large number of verification work on the supporting reagents of a series of blood cell analyzers, according to the quality control level of domestic hemolytic agent products and referring to the relevant recommended standards of the International Committee for Standardization of Hematology (ICSH) and NCCLS, and then repeatedly soliciting opinions from experts in clinical, production and scientific research. 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 units of this part: Beijing Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration, Jiangxi Tekang Technology Co., Ltd.
The main drafters of this part are Liu Xiaojun, Zhou Honghua, Zhang Zhaoyuan, Yan Xiao and Zhang Hong. 1 Scope
Reagents for blood cell analyzers
Part 2: Hemolytic agents
YY/T 0456.2—2003
This part specifies the naming and classification, requirements, test methods, inspection rules, marking, labeling, instruction manual, packaging, transportation and storage of hemolytic agents for blood cell analyzers. This part is applicable to hemolytic agents for blood cell analyzers based on the principle of 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/T0456. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, the 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 Naming and classification
3.1 Naming of hemolytic agent
Hemolytic agent
Product model
3.2 Classification
Hemolytic agent
Product model
The specific model of blood cell analyzer for which the hemolytic agent is applicable shall be clearly stated in the manufacturer's registered product standard. 4 Requirements
4.1 Appearance
The hemolytic agent shall be a transparent liquid without precipitation, particles or floccules. 4.2 External marking
4.2.1 The marking on the packaging box (box) of the hemolytic agent product shall comply with the requirements of 7.1 4.2.2 The marking on the single package (bottle) of the hemolytic agent product shall comply with the requirements of 7.2. 4.3 Instructions for use
The instructions for use shall comply with the requirements of 7.4.
4.4 Net content
The net content of the hemolytic agent shall comply with the requirements of Table 1. Table 1 Net content requirements
1L≤V≤20
500 mL≤V<1 L
100 mL≤V<500 mlwwW.bzxz.Net
V<100 mL
Maximum allowable negative deviation
YY/T 0456.2—2003
4.5 Absorption peak wavelength
The absorption peak wavelength of the hemoglobin derivative after hemolysis of the hemolytic agent shall not exceed ±10 nm of the product nominal value. 4.6 Absorbance value
The absorbance value at 750nm after the hemolytic agent acts on fresh human blood should be ≤0.012. 4.7 Blank value
When using a blood cell analyzer for determination, the measurement results of white blood cell (WBC) count ≤0.3×10°/L, hemoglobin (HGB) content ≤2 g/L.
The pH value of the hemolytic agent should not exceed ±0.20 of the product nominal value. 4.9 Accuracy
4.9.1 Original hemolytic agent: The relative deviation of hemoglobin (HGB) content should not exceed ±5%, the relative deviation of white blood cell (WBC) count should not exceed ±10%, the relative deviation of large cell grouping results should not exceed ±5%, and the relative deviation of small cell grouping results should not exceed ±8%. 4.9.2 Alternative hemolytic agents: Hemoglobin (HGB) content, white blood cell (WBC) count, large cell grouping results, and small cell grouping results should all be within the range of X ± 2SD of the results obtained by the original reagent. 4.10 WBC histogram
When testing fresh blood of normal people on an applicable hematology analyzer, the WBC histogram obtained should meet the following requirements: a) It has two population peaks of small cells and large cells; b) It conforms to the corresponding WBC grouping peak shape and its peak position mark range of the hematology analyzer; c) There should be no interference peak within 35fI. 4.11 Batch difference
The batch difference of absorption peak wavelength and pH should meet the requirements of: △λmax≤10nm, △pH≤0.20. 4.12 Stability
The hemolytic agent should have a validity period, and the retained sample within three months after the expiration should be tested in 4.1, 4.5~～4.10, and the results should meet the requirements of each item. 5 Test method
5.1 Appearance inspection
Take out an appropriate amount of hemolytic agent 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 marks on the product outer packaging box (box) and single packaging (bottle). They should meet the requirements of 4.2.1 and 4.2.2. 5.3 Instruction manual inspection
Visually inspect the product instruction manual item by item. They should meet the requirements of 4.3. 5.4 Net content determination
Use an applicable general measuring tool to measure or weigh the net mass and calculate the volume according to its density. The result should meet the requirements of 4.4. 5.5 Absorption peak wavelength determination
5.5.1 Instruments and reagents
The instruments and reagents used in the test are as follows:
a) Blood cell analyzer;
b) Spectrophotometer, wavelength range 450nm～800nm, wavelength scanning accuracy better than ±0.5nm;c) Blood: 1.5mg EDTA·Kz anticoagulant per 1mL venous blood;d) Diluent: diluent matching with hemolytic agent. 5.5.2 Measurement: Method
Add the matching diluent, anticoagulant and hemolytic agent to be tested according to the mixing ratio specified by the blood cell analyzer that matches the hemolytic agent, mix well, scan the wavelength from 450nm to 750nm on the spectrophotometer, and find the wavelength corresponding to the maximum absorption peak of the obtained absorption curve λmax, λma2
should meet the requirements of 4.4.
5.6 Determination of absorbance value
5.6.1 Instruments and reagents
Instruments and reagents shall meet the following requirements:
YY/T 0456.2—2003
a) Instrument: spectrophotometer, absorbance range: -0.500～3.000, absorbance accuracy: 0.001, and shall have a wavelength of 750nm; b) Blood: 1.5mg EDTA·K per 1mL of venous blood, anticoagulant; c) Diluent: diluent matching with hemolysing agent. 5.6.2 Measurement method
Mix the diluent, hemolysing agent and anticoagulated blood according to the ratio specified by the adapted blood cell analyzer, and after mixing, adjust the zero value with the diluent and hemolysing agent mixed in the same ratio, select 750nm wavelength on the spectrophotometer to measure the absorbance, and measure three times continuously, and calculate the average value. The result shall meet the requirements of 4.5. 5.7 Determination of blank value
When using a fully automatic or semi-automatic blood cell analyzer, first empty the original reagents in the analyzer, introduce the hemolytic agent to be tested and the matching diluent, and then use the hemolytic agent as a sample for blank determination. Perform three consecutive determinations, and the maximum value of the results of each indicator should meet the requirements of 4.7.
5.8 Determination of pH value
Take an appropriate amount of hemolytic agent and determine its pH value according to the method specified in GB/T9724-1988. Perform three consecutive determinations, and the average value should meet the requirements of 4.8.
5.9 Determination of accuracy
5.9.1 Original hemolytic agent: According to the provisions of the operating manual of the blood cell analyzer, use the fixed value blood as the specimen and perform three consecutive white blood cell counts and hemoglobin content determinations on the analyzer using the hemolytic agent to be tested. The determination results are averaged, and the relative deviation between the average value and the indicated value of the fixed value blood should meet the requirements of 4.9.1. Using the microscope counting method as the reference method, the test agent is used for cell population determination. The deviation between the average value of the results of repeated measurements three times and the average value of the reference method should meet the requirements of 4.9.1. 5.9.2 Alternative hemolytic agent: According to the provisions of the operating manual of the hemolytic agent, measure the same normal adult fresh EDTA·K anticoagulated blood on the applicable hemolytic agent, calculate the mean and standard deviation of the results of 10 repeated measurements with the original imported hemolytic agent, and obtain the x±2SD range of the measurement results of each parameter of the blood sample. Then measure the blood sample 3 times with the alternative imported hemolytic agent, calculate the average value, and the result should meet the requirements of 4.9.2.
5.10 WBC histogram test
5.10.1 Instruments and reagents
The instruments and reagents used in the test are as follows:
Instrument: Hemolytic agent applicable to the hemolytic agent; b)
Blood: Normal human venous blood, each 1mL of blood contains 1.5mg EDTA·K2 anticoagulant; c)
Dilution and cleaning agent used with the hemolytic agent (if necessary); d)
Original imported reagents.
5.10.2 Test method
According to the operating instructions of the blood cell analyzer, use blood as a specimen to measure the matching original imported reagents and the reagents to be tested on the analyzer. The white blood cell histogram should meet the requirements of 4.10. 5.11 Batch difference determination
Take three consecutive batches of hemolytic agents and measure the absorption peak wavelength and pH value respectively according to the methods specified in 5.5, 5.6, and 5.8. The difference (△) between the maximum and minimum measured values of each indicator should meet the requirements of 4.11. 5.12 Stability determination
In the production process of hemolytic agents, samples of each batch should be retained in the original packaging. Take the retained samples within three months after the expiration date and measure them according to the provisions of 5.1, 5.5~5.10. The results obtained should meet the requirements of 4.12. 3
YY/T 0456.2--2003
6 Inspection rules
6.1 Principle
The hemolytic agent shall be inspected by the technical inspection department of the manufacturer and shall be submitted for acceptance only after passing the inspection. 6.2 Inspection
It is divided into factory inspection and type inspection.
6.3 Factory inspection
6.3.1 Sampling
One production batch is an inspection batch. At least three products including the first box (box) and the last box (box) in the production process are extracted from each batch.
6.3.2 Inspection items
Inspect each item according to the requirements of 4.1~4.8 and 4.10. 6.3.3 Judgment
If one item fails, the batch is judged to be unqualified. 6.4 Type inspection
6.4.1 General
Type inspection shall be conducted in the following cases: before new products are put into production (including old products transferred to other factories); a)
b) after formal production, when production is stopped for more than six months and when production is resumed if there are major changes in the production process that may affect product performance; c)
When raw materials are changed;
When continuous production is carried out, at least once every 12 months; e)
When the national supervision and management department conducts quality spot checks. f)
6.4.2 Sampling
From the products that have passed the export inspection, three different batches shall be randomly selected, and one to three independent packages (boxes) shall be randomly selected from each batch. When the national supervision and management department conducts quality spot checks, a batch of products within three months of their expiration date shall be selected. 6.4.3 Inspection items
Inspect each item according to the requirements of 4.1 to 4.12. 6.4.4 If one item is unqualified, the batch is deemed unqualified. 7 Marking, labeling, instruction manual 7.1 The markings on the packaging box (box) of the hemolytic agent product shall include at least the following: a) Product name and model; b) Main ingredients and net content; Product use and applicable instruments; Product registration number; Product standard number to be implemented; Precautions; Production batch number and validity period; Manufacturer name and address; Product packaging, storage and transportation, and graphic markings shall comply with the relevant requirements of GB/T191-2000; If it contains cyanide, the cyanide composition and content shall be clearly indicated, and a "highly toxic" warning shall be marked in a prominent position. 7.2 The label on the single package (bottle) of the hemolytic product shall include at least the following: a) Product name and model;
Filling volume;
Production batch number and expiration date;
Storage conditions;
If it contains cyanide, there should be a "highly toxic" warning. 7.3 The packaging box (box) of the hemolytic product shall be accompanied by a certificate of conformity, which shall include at least the following: Product name and model;
Production batch number;
Inspector code;
"Qualified" word.
The instruction manual should be placed in the packaging of the hemolytic agent, and should at least include the following contents: a)
Product name, manufacturer name, address, postal code and contact number; product registration number;
Implementation product standard number;
Product specifications;
Main ingredients;
Product use and applicable instruments;
Detailed instructions for use;
Precautions;
Storage method and validity period.
Packaging, transportation and storage
The hemolytic agent should be packaged in suitable containers and sealed with a cover. 8.1
YY/T0456.2—2003
The product packaging should meet the transportation requirements specified in the contract, ensure that the product packaging is not damaged during long-distance transportation, and ensure that the reagent does not leak. 8.3 The product should be stored under the specified conditions. 51 The markings on the packaging box (box) of hemolytic agent products shall at least include the following: a)
Product name and model;
b) Main ingredients and net content;
Product use and applicable instruments;
Product registration number;
Implementation product standard number;
Precautions;
Production batch number and validity period;
Manufacturer name and address;
Product packaging, storage, transportation and graphic markings shall comply with the corresponding requirements of GB/T191-2000; if it contains cyanide, the cyanide composition and content shall be clearly indicated, and a "highly toxic" warning shall be marked in a prominent position. 7.2 The label on the single package (bottle) of the hemolytic product shall include at least the following: a) Product name and model;
Filling volume;
Production batch number and expiration date;
Storage conditions;
If it contains cyanide, there shall be a "highly toxic" warning. 7.3 The packaging box (box) of the hemolytic product shall be accompanied by a certificate of conformity, which shall include at least the following: Product name and model;
Production batch number;
Inspector code;
"Qualified" word.
The instruction manual should be placed in the packaging of the hemolytic agent, and should at least include the following contents: a)
Product name, manufacturer name, address, zip code and contact number; product registration number;
Implementation product standard number;
Product specifications;
Main ingredients;
Product use and applicable instruments;
Detailed instructions for use;
Precautions;
Storage method and validity period.
Packaging, transportation and storage
The hemolytic agent should be packaged in suitable containers and sealed with a cover. 8.1
YY/T0456.2—2003
The product packaging should meet the transportation requirements specified in the contract, ensure that the product packaging is not damaged during long-distance transportation, and ensure that the reagent does not leak. 8.3 The product should be stored under the specified conditions. 51 The markings on the packaging box (box) of hemolytic agent products shall at least include the following: a)
Product name and model;
b) Main ingredients and net content;
Product use and applicable instruments;
Product registration number;
Implementation product standard number;
Precautions;
Production batch number and validity period;
Manufacturer name and address;
Product packaging, storage, transportation and graphic markings shall comply with the corresponding requirements of GB/T191-2000; if it contains cyanide, the cyanide composition and content shall be clearly indicated, and a "highly toxic" warning shall be marked in a prominent position. 7.2 The label on the single package (bottle) of the hemolytic product shall include at least the following: a) Product name and model;
Filling volume;
Production batch number and expiration date;
Storage conditions;
If it contains cyanide, there should be a "highly toxic" warning. 7.3 The packaging box (box) of the hemolytic product shall be accompanied by a certificate of conformity, which shall include at least the following: Product name and model;
Production batch number;
Inspector code;
"Qualified" word.
The instruction manual should be placed in the packaging of the hemolytic agent, and should at least include the following contents: a)
Product name, manufacturer name, address, postal code and contact number; product registration number;
Implementation product standard number;
Product specifications;
Main ingredients;
Product use and applicable instruments;
Detailed instructions for use;
Precautions;
Storage method and validity period.
Packaging, transportation and storage
The hemolytic agent should be packaged in suitable containers and sealed with a cover. 8.1
YY/T0456.2—2003
The product packaging should meet the transportation requirements specified in the contract, ensure that the product packaging is not damaged during long-distance transportation, and ensure that the reagent does not leak. 8.3 The product should be stored under the specified conditions. 5
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