This part specifies the naming and classification, requirements, test methods, inspection rules, labels, instructions for use, packaging, transportation and storage of cleaning fluids used in blood cell analyzers. This part applies to cleaning fluids used in blood cell analyzers. YY/T 0456.1-2003 Reagents used in blood cell analyzers Part 1: Cleaning fluids YY/T0456.1-2003 Standard download decompression password: www.bzxz.net

YY/T0456 "Reagents for blood cell analyzers" is divided into 3 parts: Part 1: Cleaning fluid; Part 2: Hemolytic agent; Part 3: Dilution fluid. This part is Part 1 of YY/T0456. YY/T 0456.1—2003 This part is applicable to cleaning fluids for blood cell analyzers, which are used for cleaning and flushing the pipeline system of blood cell analyzers, and can effectively remove residual blood components and other particles that affect blood cell counts. This part is formulated on the basis of a series of quality inspections and a large number of verifications of supporting reagents for blood cell analyzers, based on the quality control level of domestic cleaning fluid products, and after 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 1: Cleaning fluid
YY/T0456.1--2003
This part specifies the naming and classification, requirements, test methods, inspection rules, marking, labeling, instruction manual, packaging, transportation and storage of cleaning fluid for blood cell analyzers. This part applies to cleaning fluid for blood cell analyzers. 2 Normative references
The clauses in the following documents constitute the clauses of this part through the use of 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 the 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 Appendix Class D3 of Part II of the Pharmacopoeia of the People's Republic of China (2000) Nomenclature and classificationWww.bzxZ.net
3.1 Naming of cleaning fluid
XXX cleaning fluid
Product model
3.2 Classification of cleaning fluid
According to its use, it can be divided into:
Cleaning fluid
Product model
Class A cleaning fluid: It can soak and rinse the measuring channel and pipeline, so as to slowly remove blood protein. Class B cleaning fluid: The cleaning fluid itself contains protease or sodium hypochlorite or other ingredients with strong removal effect on blood protein, which can effectively remove deposited protein.
3.3 Applicable models
The specific model of the blood cell analyzer to which the cleaning fluid is applicable should be clearly stated in the manufacturer's registered product standard. 4 Requirements
4.1 Appearance
The cleaning liquid should be a transparent liquid without precipitation, particles or floccules. 4.2 External marking
The external marking of the cleaning liquid product shall comply with the requirements of 7.1. 4.3 Net content
The net content of the cleaning liquid shall comply with the requirements of Table 1. YY/T0456.1—2003
1≤V≤20\1
500 mL≤V<1 L
100 mlL≤V<500 ml
V<100 ml
The pH value of the cleaning liquid shall comply with the following requirements: Table 1 Net content requirements
a) The pH value of the cleaning liquid without protease at (25±1)℃ shall be ≥7.0; b) The pH value of the cleaning liquid containing protease shall be within ±0.5 of the nominal value. 4.5 Blank count
Maximum allowable negative deviation
When using a blood cell analyzer for measurement, the measured results of white blood cell count (WBC) should be ≤0.3X10°/I, red blood cell count (RBC) ≤0.10×102/L, and platelet count (PLT) ≤20×10°/L. 4.6 Cleaning rate
The cleaning rate of the cleaning solution should meet the following requirements: a) The cleaning rate of Class A cleaning solution should not be less than 30%; b) The cleaning rate of Class B cleaning solution should not be less than 90%. 4.7 Batch difference
The batch difference of pH value should meet the requirements: △pH≤0.50. 4.8 Stability
The cleaning solution should have a specified validity period, and the retained sample within three months after the expiration should be tested in 4.1, 4.4~4.6, and the results should meet the requirements of each item.
5 Test method
Appearance inspection
Take out an appropriate amount of cleaning solution 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 marks of the product outer packaging box. 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 value determination
Take an appropriate amount of cleaning solution and measure it according to the method specified in GB/T97241988. Measure it three times in a row, and the average value should meet the requirements of 4.4. 5.5 Blank count determination
When using a fully automatic or semi-automatic blood cell analyzer, first empty the original reagent inside the analyzer, introduce the diluent matching the cleaning solution to be tested, and then use the cleaning solution as a sample for blank determination. Measure it three times in a row, and the maximum value of the results of each indicator should meet the requirements of 4.5.
5.6 Determination of cleaning rate
5.6.1 Principle
The nitrogen content in the blood stain protein soaked in the cleaning solution is determined by the Kjeldahl method, and compared with the nitrogen content in the blood stain protein not soaked in the cleaning solution, so as to indirectly evaluate the cleaning effect of the cleaning solution on the blood protein. 5.6.2 Test apparatus and device
The test apparatus and device are as follows:
b) Kjeldahl flask;
c) Kjeldahl nitrogen analyzer;
iron stand,
d) vacuum pump.
5.6.3 Reagents
The reagents used in the test are as follows:
Copper sulfate solution: 30%;
Boric acid solution: 10%;
Sodium hydroxide solution: 40%;
Sulfuric acid standard titration solution: 0.005mol/L; Methyl red-bromocresol green mixed indicator;
Sulfuric acid, potassium sulfate.
5.6.4 Preparation of blood stains
YY/T0456.1—2003
Add 1mL of distilled water and 50μI of fresh anticoagulated blood to a dry 30mL Kjeldahl flask, mix well, connect the mouth of the Kjeldahl flask to a vacuum pump, turn on the vacuum pump to reduce pressure, and then rotate and heat the Kjeldahl flask to evenly coat the inner wall of the Kjeldahl flask until the blood sample evaporates, and then bake it in an oven at 80℃ for 2h.
5.6.5 Determination method
5.6.5.1 Fill the Kjeldahl flask prepared in 5.6.4 with cleaning solution, soak it for 15 hours, then discard the cleaning solution, slowly add distilled water along the bottle wall to wash twice, and then obtain the sample bottle with residual blood stains. Use the Kjeldahl flask with residual blood stains without cleaning solution as the control bottle. Prepare two duplicate samples for each sample, and avoid shaking during the operation. Use a clean Kjeldahl flask as a blank control. 5.6.5.2 Determine the titrated acid consumed by the sample bottle, control bottle and blank control bottle according to the second method (semi-micro method) in the nitrogen determination method of Appendix ИD of Part II of the Pharmacopoeia of the People's Republic of China (2000). 5.6.6 Calculation
Calculate the cleaning rate according to the following formula:
_Average acid consumption of sample bottles minus average acid consumption of control bottles)×100%Cleaning rate (%)=(1-
[Average acid consumption of control bottles minus average acid consumption of blank control bottles] The cleaning rate result should meet the requirements of 4.6.
5.7 Batch difference determination
Take three consecutive batches of cleaning solution and determine the pH value according to the method specified in 5.4. The difference (△) between the maximum and minimum measured values ​​should meet the requirements of 4.7.
5.8 Stability determination
Each batch of cleaning solution should be packaged in the original packaging during production. Pack the retained samples. Take the retained samples within three months after the expiration date and measure them according to the provisions of 5.1, 5.4~5.6. The results should meet the requirements of 4.8. 6 Inspection rules
6.1 Principle
The cleaning liquid should be inspected by the technical inspection department of the manufacturer and can only be submitted for acceptance after passing the inspection. 6.2 Inspection
It is divided into factory inspection and periodic inspection.
6.3 Factory inspection
6.3.1 Sampling
One production batch is one inspection batch. At least three products including the first box and the last box in the production process are extracted from each batch. 6.3.2 Inspection items
YY/T 0456.1—-2003
According to 4.1~4.5. Test each item one by one. 6.3.3. Judgment. If one item is unqualified, the batch is judged unqualified. 6.4. Type inspection. 6.4.1. General. Type inspection should be carried out in the following cases: a) before the new product is put into production (including the transfer of old products to the factory); b) after formal production, if there is a major change in the production process, which may affect the product performance; c) when the production is resumed after more than six months of suspension; d) when the raw materials are changed; e) when continuous production, at least once a year; f) when the national supervision and management department conducts quality spot checks. 6.4.2. Sampling. Randomly select three different batches from the products that have passed the factory inspection, and randomly select one to three independent packages from each batch. When the national drug supervision and management department conducts supervision and spot checks on product quality, it should select a batch of products within three months of expiration. 6.4.3. Inspection items. Test each item according to the requirements of 4.1 to 4.7. 6.4.4 If any item is unqualified, the batch is deemed unqualified. 7 Marks, labels and instructions for use 7.1 The external markings of cleaning fluid products shall include at least the following: a) Product name and model; b) Main ingredients and net content; c) Product use and applicable instruments; d) Product registration number; Implementation product standard number; Precautions; g) Production batch number and validity period; Manufacturer name and address; i) Product packaging, storage and transportation, and graphic markings shall comply with the corresponding requirements of GB/T191-2000. 7.2 The outer packaging box of cleaning fluid products shall be accompanied by a certificate of conformity, which shall include at least the following: a) Product name and model; b) Production batch number; Inspector code; d) The word "qualified".
7.3 The instruction manual shall include at least the following contents: a) product name, manufacturer name, address, postal code and contact number; b) product registration number;
implemented product standard number;
d) product specifications;
main ingredients;
f) product use and applicable instruments;
detailed instructions for use;
precautions;
storage method and validity period.
Packaging, transportation and storage
The cleaning solution shall be packaged in a suitable container and sealed with a cover. YY/T 0456.1—2003
The product packaging shall meet the requirements specified in the contract and ensure that the product packaging is not damaged during long-distance transportation and the reagents do not leak. 8.2
8.3 The product shall be stored under the specified conditions. 5
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.