Some standard content:
National Metrology Technical Specification of the People's Republic of China JJE1129—2005
Calibration Speciflcation of Urine Analzers2005-03-03 Issued
Implementation on 2005-06-03
Issued by the General Administration of Quality Supervision, Inspection and Quarantine JJF 1129-2005
Callbration Specification
of Urine Analyzers
JJF 1129—2005
This specification was approved by the General Administration of Quality Supervision, Inspection and Quarantine on March 3, 2005, and came into effect on June 3, 2005.
Responsible unit: National Physical and Chemical Measurement Technical Committee Main drafting unit: Hebei Institute of Metrology Participating unit: Hebei Quality and Technical Supervision Bureau This specification entrusts the National Physical and Chemical Measurement Technical Committee to be responsible for interpreting this specification Main drafters
Ren Suili
Liu Naoming
Participating drafters:
Fei Shaoping
Sun Lingxin
JJF11292005
(Hebei Institute of Metrology)
(Hebei Institute of Metrology)
(Hebei Institute of Metrology)
[Hebei Institute of Metrology]
(Hebei Quality and Technical Supervision Bureau)
(Hebei Institute of Measurement and Science)
3 Measurement performance requirements
3.2 Indication value
4 General technical requirements
4.1 Appearance
Single bean measurement time
4.3 Insulation resistance
5 Calibration items
5.1 Environmental conditions
5.2 Standard equipment and other equipment
Calibration items and calibration methods
Appearance inspection
6.2 Preparation before calibration
Calibration of control
Indication value control
Single bean measurement time
6.6 Insulation resistance
Expression of test results
Calibration time interval
JJF 1129—2005
Expression methods and gradient tables of various test resultsAppendix A
Appendix B
Preparation of standard solution
Appendix C Calibration record format
Appendix D
Appendix E
Appendix F
Format of calibration certificate cover
Instructions
Format of calibration certificate (inside page)
【3】
【9】
1 Scope
JJF 1129—2005
Standard specification for urine analyzers
This specification applies to the calibration of various types of urine analyzers. 2 Overview
The urine analyzer (hereinafter referred to as the instrument) is used to qualitatively and quantitatively measure urine components based on the independent reaction between the tested components in urine and the corresponding test blocks on the urine test strip to produce color changes. The depth of the color change of the block on the test strip is proportional to the corresponding components in urine, thereby realizing the detection of multiple components such as relative density (SG), H, white blood cells (WBC or LEU), nitrite (NIT), protein (PRO), glucose (IU), ketone bodies (KET), urobilinogen [DHO or UH], bilirubin (BIE), red blood cells [RBC or BII] and vitamins [V].
The instrument is mainly composed of a photoelectric scanning system, a mechanical system, and a main board. , display system and accompanying test strips. 3. Performance requirements
3.1 Blank
Should meet the requirements of Table 1. Technical requirements for blank
iymaln
(somot)
mmml/l
Hemdil!
Violation: 1. The source quantity results of the instrument (SG, IH and VC. In addition to the three anti-drops, there are other two ways to express it, namely "neg" and "neg". Or \mumial", indicating normal. Appendix A, 2. According to the instructions, the measured value of the instrument should meet the requirements of Table 2. General technical requirements 4.1 Appearance 4.1, 1 The appearance of the instrument should be smooth and flat, and there should be no mechanical damage that affects the performance; the display surface should be clean and free of scratches, the readings should be clear, and the functions of various devices, regulators, switches and buttons should be good. 4.1.2 The test strips used with the instrument should be neatly cut, especially discolored, without stratification, the substrate should be straight, and there should be no falling blocks: within the shelf life. JJF 112920E5 Technical requirements for the display of the receiver 26 ~56
school: 1, for the use of the instrument year (, etc.) to explain the use of the month, point out the quality of the space to show the total space KET
16 -31
80~200
(amnn)
to show the completion of the discussion, should be empty heavy the
school number flow house of the maintenance
2. Report the instrument book, individual instrument case 2 card case release continent quantity with the result comparable note (3303)m some: 3. According to the manual, - only F mostly, (+, -) two when: small, 1. The following equipment sound right mark: instrument name, model, serial number, manufacturer and manufacturer" 4.1.4 The instrument shall be accompanied by a product manual and a license. 4.2 The instrument shall be tested in accordance with the requirements of the manufacturer's manual. 4.3 The circuit shall be 1OMQ. 5.1 The calibration conditions shall be 3.1. 1 Environment temperature 20-30)°C, no more than 85% H.5.1.2 Avoid sunlight and heat, no corrosive substances, good ventilation: 1.2 Standard liquid Other solutions in the range of 5 °C: Table 5: Table 3 Accuracy and uncertainty of airborne solutions Extended range Determination 1.X15: 5.50 imur [nms mr?] 20% (3-3) Standard: The most convenient S, pH can be obtained is 5% of the annual blood. 5.2.2 Working standard solution
pcs jd, mmd
See Table 4
Expansion technique
Weng accuracy
JR1129—2005
Working standard solution concentration and uncertainty WTIC!
Note: The midpoint, H two items are not all calculated. GL:
10% (=3)
S.2.3 Insulation resistance meter: Test: 500; Accuracy 10 level 6 Approval items and calibration methods
6.1 External double-set
Carry out according to the requirements of 4.1.
6.2 Preparation before calibration
Turn on the power of the instrument and preheat for 10m:
6.3 Calibration of blank
Lrd/l)
(uralr;bZxz.net
According to the instructions of the instrument and test paper, take an appropriate amount of blank solution into a test tube, and dip the test paper into the blank liquid (all color blocks must not pass through the blank liquid). Then take out the dried color liquid and measure on the stand. Measure three times in succession and observe the measured value. The measurement should meet the requirements of 1. 6.4 Calibration of indication
Take appropriate No. 1 and No. 2 as standard solutions respectively, and measure the indication for 5 times in succession according to the method given in 6.3. , 5 The soft test record value should meet the requirements of Table 2:
6.5 Single measurement time
The time required to start the measurement by pressing the instrument key until the measurement is completed. It can be carried out simultaneously with 6.3 or 6.4 and should meet the requirements of 4.2
6.6 Insulation resistance
When the instrument is turned on but not powered on, use a megohmmeter to measure the electrical resistance between the power plug and the outer shell (instrument grounding wire). It should meet the requirements of 4.3 Requirements.
Expression of calibration results
The calibration results should be reflected in the calibration certificate or calibration report. The calibration results of urine analyzers should include the measurement results of the air and working standards:
The calibration results should include the uncertainty: The on-site calibration should state the "on-site calibration" and the environmental conditions. 3
JJr1129—2005
The specific requirements of the calibration certificate or report are shown in Appendix C, D, E and F.
The recalibration time interval [validity period] of the calibrated urine analyzer is 1 year.
Appendix A
125 pcs/pl
500 pcsl
O remal/
JJF 1129—2005
Expression methods of various measurement results An gradient table 1.000
0 pcs/pl
125-pcsl
5on·pcs
0 mgrdl
1ongal
0. 15 g/1 :
Qangdl
15ngtll
30 mgfdt
1xmg/al
300 mgral
±(+-)
+2{++}
+3{+++)
+[(+}
+2(++)
±(+-)
12 (+ +)
+3(+++
NEGATIVE (Heg)
MODERATE
NEGA IVE (neg)
POSTTTVE(pog)
POSTTTVE(paa)
NEGAIVE(neg)
MODEELATE
0maraol/
2. 8 momol/
5.6 mmn/3
14 mmol/l
24mmol
56 riran/l
0.5raml/l
1.5 rnml/l
B mimoll
3.3 μmol/l
16 perolt
33 perxi/
o eooE
131 gmal/
μmual/l|| tt ||17 prln | 1129—2005
Omg/dl
5u rgydl
10n migfell
250 ma l
sou mgr dl
1000 riefrl
Omg/dl
Smg/di
40 mgrdl
RO rngy/al
0.2 mg/dl
Imgrdl
2 merdl
4 mg/dl
# rrighit
0mgrdl
Imgrdl
3 merdl | ++)
±(+-)
+3(++ +)
+ (+-)
-1 (+)
+3(+++)
+2(++)
+3(1F)
± (+-)
+2 (++)
+3 (+++)
±(+-)
+2 (++)
+3(+++)
NEGATIVE (neg.
MODEHATE
NEGATIVE[neg?
MODERATE
NORMAL (mor)
MLDTIE
NEGAIVE(nGR.||tt ||MODERATE
NEGATTVE(neg)
MUDERATE
NEGATTVT(neg)
MODERATE
B.1 formulation
JIF 113-2HI5
Preparation of working standard solution
B.1.1 Human urine: 20.0% hyaluronic acid, 10.0% sodium chloride, 1.0% myoglobulin, 2.0% potassium hydride, 4% vitamin C (, 3.5% edible coloring lemon, 250.0ml, B.1.2 Sodium bicarbonate: weigh 5000ml of uric acid. B.1.35601 sugar solution: weigh 25.2225% anhydrous sodium sulfate, 250.0ml of sodium bicarbonate. B.1.210l/1 sodium nitrate solution: weigh 0.344 sodium nitrate, add 500.0mlB.1.52l sodium nitrate solution: weigh 0.375 sodium nitrate: dissolve in 500.0ml8.1.55 uml/1 sodium nitrate solution: weigh 0.485 sodium nitrate, add 500.0ml sodium nitrate. R.1.7 (3.1 trul1 vitamin C thread: weigh 1.76l sodium nitrate, add 100.0ml sodium nitrate trL: B2 empty liquid: take soil 25.0, record acid solution 18.0, forging solution about 20, add water to make it reach the designated value, then measure the maximum, set the temperature to 55, use 1ml of mature sodium bicarbonate solution, 3.3T standard liquid, 3.1 working standard solution: weigh 0.2% bovine serum, 5000/l white blood cell solution, 3ml of 5000/l red blood cell solution: 5ml of 560mmol/l glucose solution, 3ml of 10mmul/l sodium nitrite solution, 1ml of 0.1ol/vitamin B solution, 0.1ml of endotoxin, 5ml of 2mmol/l hemoglobin solution, 5mmul/l urobilinogen, 5l of artificial 150.0ml water, 90.0ml sodium hydroxide solution, 150.0ml densely mixed, 50.0mol 0.1mol hydroxide solution, densely mixed, then measure the world with a H meter, add 0.1ml/1 sodium hydride to make the H reach 6.5, adjust the density to 1.015 with sodium sulphate, add water to 1000.0ml, B.3.22 No. 2 as standard solution: weigh or ox blood disinfectant 42.06, 000 l average dissolution 25m, 5000: red non-cell solution 30,560mmcl/grape solution 5ml, 1 (mmol sodium oxychloride water solution 1) l, 0.1ol/vitamin solution 20ml, internal agent 0.6ml2mmo tannin solution 37.5ml: 5mmnl/charcoal point 20 rl. Artificial urine 150.0 ml, potassium isocyanate 90.0 ml, buffer solution 150.0 m, 0.1 mal/mL hydrogen peroxide. 0.0 blood, package, natural, H, H, add [mo oxygen oxidizing agent, make the car 7.: still raise the rate 1.025, water 1000.0: || tt || 1. There are large-scale strategies in the market, the total type of the pool can be very reagents, this heart-shaped drug, the year of Le Ming more can year 35 - base 9 taste etc.:
2, with more than one to install, the version of the North recognized, is, Niu Xue self-production group you, red list you product is difficult to determine the product, the system can be divided into new forms.
Appendix C
Inspection unit
To the factory
Only the number
Cabinet for Lu degree
General technical requirements:
Blank calibration:
Indication calibration:
Single measurement call time:
Absolute resistance:
6Remarks:
JJF 1129 - -20 No. 5
Calibration record format
Certificate abbreviation
Instrument model
Verifier
Verifier
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