JJF 1129-2005Calibration specification of urine analyzers (English PDF)

1 Scope (1)

2 Overview (1)

3 Metrological performance requirements (1)

4 General technical requirements (1)

5 Calibration conditions (2)

6 Calibration items and calibration methods (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

NIT

/(µmol/l)

PRO

GLU

/(mmol/l)

KET

/(mmol/l)

URO

/(µmol/l)

BIL

/(µmol/l)

RBC

/(mmol/l)

measuring

result

1.000~

1.010

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.