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Calibration specification of urine analyzers
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JJF 1129-2005
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Basic data Standard ID | JJF 1129-2005 (JJF1129-2005) | Description (Translated English) | Calibration specification of urine analyzers | Sector / Industry | Metrology & Measurement Industry Standard | Classification of Chinese Standard | A61 | Classification of International Standard | 17.180 | Word Count Estimation | 19,192 | Date of Issue | 2005-03-03 | Date of Implementation | 2005-06-03 | Issuing agency(ies) | State Administration of Quality Supervision, Inspection and Quarantine | Summary | This standard applies to all types of urine analyzer calibration. |
JJF 1129-2005: Calibration specification of urine analyzers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Calibration specification of urine analyzers
National Metrology Technical Specification of the People's Republic
Urine Analyzer Calibration Specifications
Released on.2005-03-03
2005-06-03 implementation
The General Administration of Quality Supervision, Inspection and Quarantine issued
Urine Analyzer Calibration Specifications
ofUrineAnaly
Zers
This specification was approved by the General Administration of Quality Supervision, Inspection and Quarantine on March 3,.2005, and
It will take effect on June 3,.2005.
Focal Point. National Physical and Chemical Metrology Technical Committee
Main drafting unit. Hebei Institute of Metrology
Participated in drafting unit. Hebei Bureau of Quality and Technical Supervision
This specification entrusts the National Physical and Chemical Measurement Technical Committee to explain
The main drafters of this specification.
Ren Yanli (Hebei Institute of Metrology)
Liu Zengming (Hebei Institute of Metrology)
Liu Yan (Hebei Institute of Metrology)
Participate in the drafters.
Wang Shaoping (Hebei Institute of Metrology)
Ban Li (Hebei Province Quality and Technical Supervision Bureau)
Sun Lingxin (Hebei Institute of Metrology)
table of Contents
1 Scope (1)
2 Overview (1)
3 Metrological performance requirements (1)
3.1 blank (1)
3.2 indication (1)
4 General technical requirements (1)
4.1 Appearance (1)
4.2 Single measurement time (2)
4.3 Insulation resistance (2)
5 Calibration conditions (2)
5.1 Environmental conditions (2)
5.2 Standard solutions and other equipment (2)
6 Calibration items and calibration methods (3)
6.1 Visual inspection (3)
6.2 Preparation before calibration (3)
6.3 blank calibration (3)
6.4 Calibration of indication values (3)
6.5 Single measurement time (3)
6.6 Insulation resistance (3)
7 Expression of calibration results (3)
8 re-study interval (4)
Appendix A Representation of various measurement results and gradient table (5)
Appendix B Preparation of working standard solution (7)
Appendix C Calibration Record Format (8)
Appendix D Calibration Certificate Cover Format (9)
Appendix E Calibration Instructions (10)
Appendix F Calibration Certificate (Inside) Format (11)
Urine Analyzer Calibration Specifications
1 Scope
This specification applies to the calibration of various types of urine analyzers.
2 Overview
The urine analyzer (hereinafter referred to as the instrument) is based on the measured components in the urine and the corresponding test blocks on the urine test strip.
Independent reactions produce color changes for qualitative and quantitative measurement of urine composition. Test strip color block color change
The depth is proportional to the corresponding components in the urine, so that the relative density (SG), pH, and whiteness of the urine are achieved.
Cell (WBC or LEU), nitrite (NIT), protein (PRO), glucose (GLU), ketone body (KET),
Urobilinogen (URO or UBG), bilirubin (BIL), red blood cells (RBC or BLD), and vitamin C (VC)
Detection of the component.
The instrument is mainly composed of photoelectric scanning system, mechanical system, motherboard, display system and attached test strips.
3 Metrological performance requirements
3.1 blank
Should meet the requirements of Table 1.
Table 1 Technical requirements for instrument blank
Parameter SG pH
WBC
/( /μl)
NIT
/(μmol/l)
PRO
/(g/l)
GLU
/(mmol/l)
KET
/(mmol/l)
URO
/(μmol/l)
BIL
/(μmol/l)
RBC
/( /μl)
VC
/(mmol/l)
measuring
result
1.000~
1.010
5.0~
6.0
0 0 0 0 0 ≤3.4 0 0 0
Note. 1. The measurement results of the instrument (except SG, pH and VC) have two other representation methods, namely “-” and
"neg", both of which are negative; or "normal", indicating normal. See Appendix A.
2. According to the instructions, individual instruments GLU ≤ 0.6mmol/l.
3.2 indication
The measured values of the instrument shall comply with the requirements of Table 2.
4 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 affecting the working performance; the surface of the display should be smooth and clean.
No scratches, clear readings; good function of each device, regulator, switch and buttons.
4.1.2 Test strips used with the instrument should be neatly cut, no discoloration, no delamination, flat substrate, no falling block
Like; during the warranty period.
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