YY/T 0654-2017 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0654-2017 | English | 145 |
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Automatic chemistry analyzer
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| YY/T 0654-2008 | English | 519 |
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Automatic Chemistry Analyzer
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YY/T 0654-2017: Automatic chemistry analyzer---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0654-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.100
C 44
Replacing YY/T 0654-2008
Automatic chemistry analyzer
Issued on. MARCH 28, 2017
Implemented on. APRIL 1, 2018
Issued by. China Food and Drug Administration of China
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Classification... 6
5 Requirements... 7
6 Test methods... 9
7 Marks and instructions for use... 15
8 Packaging, transport and storage... 15
Annex A (normative) Preparation method of 50g/L sodium nitrite solution... 17
Annex B (informative) Density of pure water at different temperatures at
standard atmospheric pressure... 18
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard was revised based on YY/T 0654-2008.Compared with YY/T
0654-2008, in addition to the editorial modifications, the main technical changes
are as follows.
- modified the applicable scope as automatic biochemical analyzer for
quantitative analysis of various samples by ultraviolet-visible
spectrophotometry;
- in normative references, modified GB/T 14710 “The environmental
requirements and test methods for medical electrical equipment” to GB/T
14710 “Medical electrical environment requirements and test methods.’
- deleted GB/T 2829 “Sampling procedures and tables for periodic inspection
by attributes (Apply to inspection of process stability)” from normative
references;
- deleted YY 0466 “Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied” (ISO 15233.2000, IDT)
from normative references;
- modified the sample carryover rate as not exceeding 0.1% and modified its
test methods (see 5.8, 6.7);
- adjusted the UREA (urea) test range in the intra-assay precision of clinical
projects to 7.0 mmol/L ~ 11.0 mmol/L (see 5.10);
- added the requirements and test methods for applicable provisions of GB
4793.9 and YY 0648 in safety requirements (see 5.13, 6.12);
- added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility
requirements and test methods (see 5.14, 6.13);
- in the absorbance stability test method, the potassium dichromate solution
used at a wavelength of 340 nm was changed to a yellow orange G
solution (see 6.4);
- in the absorbance repeatability test method, the potassium dichromate
solution used at a wavelength of 340 nm was changed to a yellow orange
G solution (see 6.5);
- the accuracy and repeatability of the test method is modified by the
manufacturer to choose one of two methods (see 6.8);
- the mark and instructions for use shall be changed to meet the requirements
of GB/T 29791.3 (see 7);
- Annex B was replaced by the 1990 International Temperature Standard
Pure Water Density Table.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration of China.
This Standard shall be under the jurisdiction of National Technical Committee
on Medical Clinical Laboratory and In Vitro Diagnostic System of
Standardization Administration of China (SAC/TC 136).
The drafting organizations of this Standard. Beijing Medical Device Inspection
Institute, Hitachi High-Tech (Shanghai) International Trade Co., Ltd. Beijing
Branch, Shanghai Kehua Experimental System Co., Ltd., Beijing Songshang
Technology Co., Ltd., Roche Diagnostics Products (Shanghai) Co., Ltd.,
Beckman Coulter Trading (China) Co., Ltd.
Main drafters of this Standard. Zhao Bingfeng, Cheng Qing, Su Tao, Fu
Yuguang, Tian Wei, Bi Xiao.
Automatic chemistry analyzer
1 Scope
This Standard specifies the terms and definitions, classification, requirements,
test methods, marks and instructions for use, packaging, transport and storage
of automatic chemistry analyzer (hereinafter referred to as the analyzer).
This Standard is applicable to automatic biochemical analyzer for quantitative
analysis of various samples by UV-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 document (including any
amendments) applies.
GB/T 191, Packaging and storage marks
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 absorbance
The ratio of the transmitted light intensity to the incident light intensity is the
transmittance; the common logarithm of the reciprocal of the transmittance is
called the absorbance.
3.3 carry-over
Carrying a test sample reaction by the measurement system to another analyte
discontinuity that detects the sample reaction, thereby erroneously affecting the
amount of performance of the other test sample.
3.4 stray light
Light other than the wavelength that deviates from the normal light path and
reaches the detector.
4 Classification
4.1 Instrument type
Discrete, mobile.
4.3 Light path form
Front splitting or post splitting.
4.4 Colorimetric container type
Recycling or single use.
5 Requirements
5.1 Normal working environment
5.1.1 Power supply voltage. 220V ± 22V, 50Hz ± 1Hz.
5.2 Stray light
Absorbance is not less than 2.3.
5.3 Absorbance linear range
The maximum absorbance of the relative bias within ±5% shall be no less than
2.0.
5.5 Absorbance stability
The change in absorbance shall not be greater than 0.01.
5.6 Absorbance repeatability
Expressed by coefficient of variation, not exceeding 1.5%.
5.7 Temperature accuracy and volatility
The temperature value is within ±0.3°C of the set value, and the fluctuation is
not more than ±0.2°C.
5.8 Sample carry-over rate
The sample carry-over rate shall not exceed 0.1%.
5.10 Intra-assay precision of clinical projects
The coefficient of variation (CV) shall meet the requirements of Table 2.
5.11 Appearance requirements
The appearance shall meet the following requirements.
5.12 Environmental test requirements
Meet the requirements of the applicable provisions of GB/T 14710.
5.13 Safety requirements
Meet the requirements of the applicable provisions of GB 4793.1, GB 4793.9,
YY 0648.
5.14 Electromagnetic compatibility requirements
Meet the requirements of the applicable provisions of GB/T 18268.1 and GB/T
18268.26.
6 Test methods
6.1 Stray light
Using deionized water as a reference, determine a 50 g/L sodium nitrite
standard solution at 340 nm (see Annex A for the preparation method); or
measure the absorbance of the JB400 cut-off filter at 340 nm using air as a
reference, which shall meet the requirements of 5.2.
6.3 Absorbance accuracy
Use deionized water as a reference. Determine the absorbance of the
potassium dichromate standard solution of which the absorbance is about 0.5
(with deionized water as blank, allowable deviation is ±5%) and 1.0 (with
deionized water as blank, allowable deviation of ±5%) at 340 nm on the analyzer.
6.4 Absorbance stability
Perform the absorbance stability measurement at any wavelength in the 340
nm and 600 nm to 700 nm wavelength range of the analyzer. The 340 nm
measurement solution is Orange G standard solution with an absorbance of 0.5
(with deionized water as a blank and an allowable deviation of ±5%).
6.5 Absorbance repeatability
Carry out the absorbance repeatability measurement at 340 nm wavelength of
the analyzer. The 340 nm wavelength measurement solution is Orange G
standard solution with an absorbance of 1.0 (with deionized water as a blank
and an allowable deviation of ±5%).
6.6 Temperature accuracy and fluctuation
Place the probe of the temperature tester with an accuracy of not less than
0.1°C, or the same precision and calibrated special temperature test tool
provided by the analyzer manufacturer, at the position specified by the
manufacturer. After the temperature is stable, the temperature shall be
measured every other analyzer interval or 30s. The measurement time is the
analyzer's nominal maximum reaction time or 10min.
6.10 Appearance
Perform visual inspection, which shall comply with the provisions of 5.11.
6.11 Environmental test
Test in accordance with the method specified in GB/T 14710, the results shall
comply with the provisions of 5.12.
6.12 Safety requirements
Test according to the methods specified in GB 4793.1, GB 4793.9, YY 0648,
the results shall meet the requirements of 5.13.
6.13 Electromagnetic compatibility
Test according to the method specified in GB/T 18268.1 and GB/T 18268.26,
the results shall comply with the provisions of 5.14.
7 Marks and instructions for use
Meet the requirements of GB/T 29791.3.
8 Packaging, transport and storage
8.1 Packaging
The analyzer packaging shall meet the following requirements.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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