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YY/T 0654-2017

Chinese Standard: 'YY/T 0654-2017'
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Detail Information of YY/T 0654-2017; YY/T0654-2017
Description (Translated English): Automatic chemistry analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 12,191
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Older Standard (superseded by this standard): YY/T 0654-2008
Drafting Organization: Beijing Medical Device Inspection Institute, Hitachi High-Tech (Shanghai) International Trade Co., Ltd. Beijing Branch, Shanghai Branch, the experimental system Co., Ltd., Song Song Technology Co., Ltd. Beijing, Roche Diagnostics (Shanghai) Co., Ltd., Beckman Coulter Commerce (China) Co., Ltd.
Administrative Organization: National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136)
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 38
Proposing organization: China Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration

YY/T 0654-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 0654-2008
Automatic chemistry analyzer
全自动生化分析仪
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);
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
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
Recycling or single use.
5 Requirements
5.1 Normal working environment
5.1.1 Power supply voltage. 220V ± 22V, 50Hz ± 1Hz.
5.1.2 Ambient temperature. 15°C~30°C.
5.1.3 Relative humidity. 40%~85%.
5.1.4 Atmospheric pressure. 86.0kPa~106.0kPa.
NOTE. If the conditions in 5.1.2~5.1.4 are inconsistent with the conditions stated in the manufacturing
mark, the conditions specified in the product shall prevail.
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.
5.4 Absorbance accuracy
Comply with Table 1.
Table 1 -- Absorbance accuracy requirements
Absorbance value Allowable error
0.5 ±0.025
1.0 ±0.07
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
ci - relative concentration;
i - concentration serial number, range is 5~11.
Where,
Ai - the average value of the absorbance actually measured at a certain
concentration point;
ci - relative concentration;
n - selected number of concentration;
i - concentration serial number, range is 1~4.
The absorbance range of relative bias less than ±5% is the linear range of
absorbance and shall meet the requirements of 5.3.
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.
Repeat the measurement 3 times and calculate the difference between the
arithmetic mean of the 3 measurements and the standard value, which shall
meet the requirements of Table 1.
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%). The
measurement solution at any wavelength in the wavelength range of 600 nm to
700 nm has an absorbance of 0.5 (in terms of absorbance of 0.5). Deionized
water is blank, allowing a deviation of ±5%) of copper sulfate standard solution.
According to the following setting conditions a) and b), the absorbance of the
above solution shall be measured on the analyzer, and the difference between
Vr - reagent addition volume.
NOTE 1. Surfactants can be added to deionized water (such as TritonX-100).
NOTE 2. Allow adoption of 600nm~700nm as a sub-wavelength.
6.8 Sample loading accuracy and repeatability
It can be divided into two types. colorimetric and weighing methods,
manufacturers can choose one of two methods.
6.8.1 Weighing method
The weighing method is determined as follows.
a) Start the test after balancing the analyzer, degassed deionized water, etc.
in a constant temperature, constant humidity laboratory for several hours.
Prepare a suitable container (to prevent moisture evaporation in the
container) and zero on an electronic balance with a graduation value of
0.01 mg;
b) Place the container in the appropriate position, control the reagent needle
or sample needle to add the specified amount of degassed deionized
water to the container, and weigh the mass on the electronic balance;
c) Repeat weighing 20 times for each specified addition amount. The actual
amount added each time is equal to the mass of degassed deionized
water divided by the density of pure water at that temperature. The density
of pure water at different temperatures is shown in Annex B. Calculate the
coefficient of variation according to formula (4), calculate the loading error
according to formula (6), and the result shall meet the requirements of 5.9.
Where,
Bi - loading deviation;
Xi - average amount of actual addition;
T - prescribed amount.
6.8.2 Colorimetric method
Colorimetric method is determined by the following steps.
a) Preparation of Orange G serum (pigment solution). weigh 0.35 g of
Orange G powder with an electronic balance with a graduation value of
measured on a spectrophotometer (478nm ± 1nm).
Calculate the actual sample addition amount according to formula (9).
e) Calculate the coefficient of variation of the sample and the accuracy of the
sample according to formula (4) and formula (6). The result shall meet the
requirements of 5.9.
6.9 Intra-assay precision of clinical projects
Repeat the test u......
Related standard:   YY/T 0653-2017  YY/T 0657-2017
   
 
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