Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is a reversion of YY/T 0654-2008. In addition to editorial changes, the following main technical changes have been made with respect to YY/T 0654-2008:
——The applicable range has been changed to an automatic chemistry analyzer for quantitative analysis of various samples by ultraviolet-visible spectrophotometry;
——GB/T 14710 The environmental requirements and test methods for medical electrical equipment referenced in "Normative references" has been changed to GB/T 14710 Environmental requirement and test methods for medical electrical equipment;
——GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of stability for productive process) referenced in "Normative references" has been deleted;
——YY 0466 Medical devices — Symbols to be used with medical device labels labelling and information to be supplied (ISO 15233: 2000, IDT) referenced in "Normative references" has been deleted;
——The sample carry-over rate has been changed to "shall be no more than 0.1%" and the test method has been changed (see 5.8 and 6.7);
——The test range of UREA in the in-batch precision of clinical items has been adjusted to 7.0 mmol/L ~ 11.0 mmol/L (see 5.10);
——The requirements and test method for applicable provisions in GB 4793.9 and YY 0648 have been added in the safety requirements (see 5.13 and 6.12);
——The electromagnetic compatibility requirements and test methods in GB/T 18268.1 and GB/T 18268.26 have been added (see 5.14 and 6.13);
——The potassium dichromate solution used at the wavelength of 340 nm in the absorbance stability test method has been changed to Orange G solution (see 6.4);
——The potassium dichromate solution used at the wavelength of 340 nm in the absorbance repeatability test method has been changed to Orange G solution (see 6.5);
——The content in the test method of sample addition accuracy and repeatability has been changed to "the manufacturer may choose either colorimetry method or weighing method" (see 6.8);
——The content in the marking and instructions for use has been changed to "it shall meet the requirements of GB/T 29791.3" (see 7);
——Annex B has been changed to refer to the pure water density of the International Temperature Scale of 1990.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This collateral standard is under the jurisdiction of SAC/TC 136 National Technical Committee on Medical Clinical Laboratory Testing and Invitro Diagnostic Test Systems Standardization Administration of China.
Automatic chemistry analyzer
1 Scope
This standard specifies the terms and definitions, classification, requirements, test methods, marking and instructions for use, as well as packaging, transportation and storage of the automatic chemistry analyzer (hereinafter referred to as analyzer).
This standard is applicable to the automatic chemistry analyzer for quantitative analysis of various samples by ultraviolet-visible spectrophotometry.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendment) applies.
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 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use — Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
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
GB/T 29791.3 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
absorbance
absorbance is the common logarithmic of the reciprocal of the transmittance, of which is the ratio of transmitted light intensity to incident light intensity
Note: In this document, all absorbance refer to the values when the optical path is 10 mm
3.2
automatic chemistry analyzer
automatic chemistry analyzer with automation in the whole analytical processes (sample and reagent filling, interaction, chemical and biological analysis, result calculation and result readout)
3.3
carry-over
amount of analyte discontinuity carried by the measurement system from one test sample reaction to another test sample reaction, thereby erroneously affecting the amount of expression of the other test sample
3.4
stray light
light outside the determination wavelength and deviates from the normal light path and reach the detector
4 Classification
4.1 Instrument type
Discrete type and flow type.
4.2 Monochrome device
Filter type, grating type or other types.
4.3 Optical path form
Front light split or back light split.
4.4 Types of colorimetric containers
Recycled type or disposable type
5 Requirements
5.1 Normal working conditions
5.1.1 Supply voltage: 220 V ± 22 V, 50 Hz ± 1 Hz;
5.1.2 Ambient temperature: 15°C ~ 30°C;
5.1.3 Relative humidity: 40% ~ 85%.
5.1.4 Atmospheric pressure: 86.0 kPa ~ 106.0 kPa.
Note: In case of inconsistency between the conditions specified in 5.1.2 ~ 5.1.4 and the manufacturer's nominal conditions, the conditions specified in the product shall prevail.
5.2 Stray light
The absorbance is not less than 2.3.
5.3 Linear range of absorbance
The maximum absorbance with relative bias within ±5% shall not be less than 2.0.
5.4 Accuracy of absorbance
It shall meet those specified in Table 1.
Table 1 Requirements for accuracy of absorbance
Absorbance value Allowable error
0.5 ± 0.025
1.0 ± 0.07
5.5 Stability of absorbance
The change of absorbance shall not be greater than 0.01.
5.6 Repeatability of absorbance
The coefficient of variation (CV) for the repeatability of absorbance shall not be greater than 1.5%.
5.7 Temperature accuracy and fluctuation
The temperature value is within ± 0.3°C of the set value, and the fluctuation is no more than ± 0.2°C.
5.8 Sample carry-over rate
The sample carry-over rate shall be no more than 0.1%.
5.9 Sample addition accuracy and repeatability
Conduct the test for the instrument's nominal minimum and maximum sample addition amount as well as the sample addition amount of about 5 μL, with the deviation of the sample addition accuracy no more than ±5% and the CV no more than 2%.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
7 Marking and instructions for use
8 Packaging, transportation and storage
Annex A (Normative) Preparation method of 50g/L sodium nitrite solution
Annex B (Informative) Density of pure water at different temperatures at standard atmospheric pressure
