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YY/T 0589-2016 PDF English

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YY/T 0589-2016: Electrolyte analyzer
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YY/T 0589: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 0589-2016English180 Add to Cart 0-9 seconds. Auto-delivery Electrolyte analyzer Valid
YY/T 0589-2005English519 Add to Cart 3 days Electrolyte analyzer Obsolete

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YY/T 0588   YY/T 0653   YY 0648   YY/T 0576   

YY/T 0589-2016: Electrolyte analyzer

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PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 Replacing YY/T 0589-2005 Electrolyte analyzer ISSUED ON: MARCH 23, 2016 IMPLEMENTED ON: JANUARY 01, 2017 Issued by: China Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 5 2 Normative references ... 5 3 Classification and basic parameters ... 6 4 Requirements ... 7 5 Test method ... 8 6 Signs, labeling, instruction manual ... 12 7 Packaging, transportation and storage ... 14 Appendix A (Normative) Preparation method of fixed value mass control test solution ... 15 Electrolyte analyzer

1 Scope

This Standard specifies the classification and basic parameters, requirements, test methods, signs, labeling, instruction manual and packaging, transportation, and storage of electrolyte analyzers. This Standard applies to electrolyte analyzers which use ion-selective electrodes as sensors (hereafter referred to as instruments); the instruments are suitable for human clinical electrolyte testing. The electrolyte module on the biochemical analyzer can refer to this Standard.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191, Packaging - Pictorial marking for handling of goods GB 4793.1, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements GB/T 14710, Environmental requirement and test methods for medical electrical equipment GB/T 18268.1, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements GB/T 18268.26, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements YY 0648, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 4.2.4 Save and print the measurement data of the instrument. 4.3 Appearance The appearance shall meet the following requirements: a) The whole machine shall be complete, without scratches and cracks; b) The fastener connection shall be firm and reliable, without loosening; c) There shall be no obvious defects on the surface of metal parts. 4.4 Safety It shall meet the requirements of the applicable clauses in GB 4793.1 and YY 0648. 4.5 Environmental test It shall meet the requirements of the applicable clauses in GB/T 14710. 4.6 Electromagnetic compatibility It shall meet the requirements of the applicable clauses in GB/T 18268.1, GB/T 18268.26.

5 Test method

5.1 Test conditions Normal working conditions of the instrument: -- power supply: AC 220 V ± 22 V, 50 Hz ± 1 Hz; or other applicable power supply; -- ambient temperature: 15 °C ~ 30 °C; -- relative humidity: not more than 85%; -- away from interference sources of strong electromagnetic fields. Note: When the conditions in 5.1 are inconsistent with the manufacturer's product regulations, the product regulations shall prevail. The manufacturer shall state in the product standard. 5.2 Accuracy For the sample, select a reference substance that has fixed value data based on serum. SD -- standard deviation; -- the average value of the 10 continuously output measured values. 5.4 Linear For the sample, select No. 1, No. 2, No. 3, No. 4 and No. 5 K+, Na+, Cl- fixed mass control test solution that is prepared in Table A.1 of Appendix A. For the sample, select No. 1, No. 2, No. 3, No. 4 and No. 5 iCa2+, Li+ fixed mass control test solution that is prepared in Table A.2 of Appendix A. Under normal working conditions of the instrument, first, perform the calibration according to the conventional test procedure; then, respectively measure each of the certain value of the mass control test solution continuously for 3 times in sequence; take the average value as the actual-measured value; for each analytical element, there is a group of measured value Y of different concentrations. Between a group of actual-measured values of different concentrations of each analytical element, Yn, and a group of nominal values of different concentrations corresponding to it, X, firstly, use the linear regression analysis method to calculate the linear regression parameters, a (slope) and b (intercept), of each analytical element; derive the linear regression equation Y = a · X + b of each analytical element. For each analytical element, substitute a known group of nominal values X of different concentrations into their corresponding linear regression equations to obtain a corresponding group of linear regression values Y. Respectively calculate the absolute value of absolute deviation or relative deviation of the actual-measured value Yn relative to the linear regression value Y of different concentrations of each analytical element; calculate the correlation coefficient of linear regression |r|, which shall meet the requirements of 4.1.3. 5.5 Stability For the sample, select No. 3 K+, Na+, Cl- fixed value mass control test solution that is prepared in Table A.1 of Appendix A. For the sample, select No. 3 iCa2+, Li+ fixed value mass control test solution that is prepared in Table A.2 of Appendix A. Under normal working conditions of the instrument, first, perform the calibration in accordance with the conventional test procedures; then, test the No. 3 fixed- value mass control test solution; perform the test, respectively, at 0 h, 4 h, and 8 h, and record the measured values of each analytical element; obtain three Where: CHL -- Carrying pollution rate; L1 ~ L4 -- the 1st ~ 4th measurement value of each group of low concentration solution; H1 ~ H4 -- the 1st ~ 4th measurement value of each group of high concentration solution. 5.7 Function Perform the function test according to the use method of the instruction manual and the operation prompt of the display, which shall comply with the provisions of 4.2. 5.8 Appearance Visually inspect, which shall meet the requirements of 4.3. 5.9 Safety Perform according to the test methods of the applicable clauses in GB 4793.1 and YY 0648. 5.10 Environmental test Perform the test according to applicable test procedures and test methods of GB/T 14710. During the high temperature storage, low temperature storage, damp heat storage and vibration collision tests, the electrode, pump tube and reagents can be withdrawn; the test results shall meet the requirements of 4.4. 5.11 Electromagnetic compatibility Perform the test according to the applicable clauses in GB/T 18268.1 and GB/T 18268.26, which shall meet the requirements of 4.6.

6 Signs, labeling, instruction manual

6.1 Overview The text of the signs, labeling and instruction manual must be in Chinese; other languages can be attached. The use of Chinese shall conform to the national language standards. The text, symbols, graphics, tables, numbers, photos, pictures, etc. of the instruction manual, labeling and packaging marks shall be accurate, clear and standardized. The symbols which are used in signs, labeling and instruction manual shall meet the requirements of YY/T 0466.1.

Appendix A

(Normative) Preparation method of fixed value mass control test solution A.1 Equipment A.1.1 Analytical balance (the maximum weighing is not more than 200 g; the accuracy is 0.1 mg) and weighing bottle with lid. A.1.2 Volumetric flask (1 000 mL, grade A) and pipette (10 mL, grade A). A.1.3 Electric oven, beaker (100 mL) and dryer. A.2 Reagent A.2.1 Potassium chloride [KCl], guaranteed reagent (content ≥ 99.5%). A.2.2 Sodium chloride [NaCl], guaranteed reagent (content ≥ 99.5%). A.2.3 Sodium acetate [CH3COONa], guaranteed reagent (content ≥ 99.0%). A.2.4 Boric acid [H3BO3], guaranteed reagent (content ≥ 99.0%). A.2.5 Anhydrous lithium chloride [LiCl], guaranteed reagent (content ≥ 99.0%). A.2.6 Anhydrous calcium chloride [CaCl2], guaranteed reagent (content ≥ 99.5%). A.2.7 Sodium 3-(N-morpholino) propanesulfonate [MOPSNa], guaranteed reagent (content ≥ 99.0%). A.2.8 3-(N-morpholino) propanesulfonic acid [MOPS], guaranteed reagent (content ≥ 99.0%). A.2.9 Deionized water [resistivity ≥ 10 mΩ]. A.3 Preparation requirements and methods A.3.1 Preparation requirements According to Table A.1, Table A.2, prepare 5-point fixed value mass control test solution. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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