GB/T 26124-2011 PDF English
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GB/T 26124-2011 | English | 290 |
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In Vitro Diagnostic Reagent (kit) for Clinical Chemistry
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GB/T 26124-2011: In Vitro Diagnostic Reagent (kit) for Clinical Chemistry---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/GBT26124-2011
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
In Vitro Diagnostic Reagent (kit) for Clinical Chemistry
Issued on. MAY 12, 2011
Implemented on. NOVEMBER 1, 2011
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 4
4 Naming and Classification... 9
5 Requirements... 9
6 Test Methods... 11
7 Markings, Labels and Instructions for Use... 15
8 Packaging, Transportation and Storage... 22
Bibliography... 23
Foreword
This Standard was drafted in accordance with the rules in GB/T 1.1-2009 Directives
for Standardization - Part 1.Structure and Drafting of Standards.
Please be noted that certain content of this document might involve patents. The
institution issuing this document does not undertake the responsibility of identifying
these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee 136 on
System of Medical Clinical Test Lab and In Vitro Diagnostic System of Standardization
Administration of China (SAC/TC 136).
The drafting organization of this Standard. Beijing Institute of Medical Device Testing.
The main drafters of this Standard. Bi Chunlei, Liu Yi, Zhang Hong, Wang Jun, Hu
Dongmei.
In Vitro Diagnostic Reagent (kit) for Clinical Chemistry
1 Scope
This Standard specifies the general technical requirements for the quality inspection
of in vitro diagnostic reagent (kit) for clinical chemistry [hereinafter referred to as
“reagent (kit)”], including terms and definitions, classification and naming,
requirements, test methods, labels and instructions for use, packaging, transportation
and storage.
This Standard is applicable to in vitro diagnostic reagents (kits) based on the principle
of spectrophotometry used in the quantitative inspection of clinical chemistry items in
medical laboratories.
This Standard does not apply to.
a) Performance evaluation reagents (for example, reagents for research
purposes only);
b) In vitro diagnostic reagents for clinical chemistry in POCT (Point of Care
Testing).
2 Normative References
The following documents are indispensable to the application of this document. In
terms of references with a specified date, only versions with a specified date are
applicable to this document. In terms of references without a specified date, the latest
version (including all the modifications) is applicable to this document.
GB 3100 The International System of Units and Its Application
YY 0466-2003 Medical Devices - Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied
YY/T 0638 In Vitro Diagnostic Medical Devices - Measurement of Quantities in
Biological Samples - Metrological Traceability of Assigned Values for Catalytic
Concentration of Enzymes in Calibrators and Control Materials
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 In Vitro Diagnostic Reagent
In vitro diagnostic reagent refers to the chemical, biological or immunological
components, solutions or preparations that are expected to be used by the
manufacturer as an in vitro diagnostic medical device.
3.2 Clinical Chemistry Reagent
Clinical chemistry reagent refers to an in vitro diagnostic reagent based on the principle
of spectrophotometry used in the quantitative inspection of clinical chemistry items in
medical laboratories.
3.3 Kit
Kit refers to a set of components packaged together to complete a specified in vitro
diagnostic test.
3.4 Accuracy
Accuracy refers to the degree of consistency between a measured value and an
acceptable reference value.
3.5 Reference Material
Reference material refers to a material or substance that has one or multiple sufficiently
uniform and well-determined characteristics to calibrate measurement devices,
evaluate measurement methods or assign values to materials.
3.6 Certified Reference Material; CRM
Certified reference material refers to a reference material with an attached certificate;
one or multiple characteristic values are determined by an established traceability
procedure, so that it can be traced to an accurate reproducible measurement unit
representing the characteristic value. Each certified characteristic value is
accompanied by the uncertainty of a given confidence level.
4 Naming and Classification
4.1 Naming
The product name of in vitro diagnostic reagents (kits) for clinical chemistry shall
include the Chinese name of the corresponding test item, and if necessary, the English
(abbreviated) name may be added.
4.2 Classification
The composition, specifications and detection principle of the reagents (kits) shall be
described.
5 Requirements
5.1 Appearance
The appearance shall comply with the normal appearance requirements specified by
the manufacturer.
5.2 Net Weight
The net weight of liquid reagents shall be not less than the indicated value.
5.3 Reagent Blank
5.4 Analytical Sensitivity
When the reagents (kits) are used to test n units of tested object, the difference in
absorbance (A) or the change rate of absorbance (A/min) shall comply with the
range provided by the manufacturer.
5.5 Linearity Range
The analytical performance within the linearity range of the reagents (kits) shall comply
with the following requirements.
5.6 Precision of Measurement
5.7 Accuracy
The accuracy of the reagents (kits) shall comply with the requirements specified by the
manufacturer.
5.8 Stability
The following methods may be selected for the verification of stability.
6 Test Methods
6.1 Basic Requirements for Instruments
Spectrophotometer or biochemical analyzer. the wavelength range covers 340 nm to
700 nm. The biochemical analyzer shall be equipped with a constant-temperature
device (precision ± 0.1 °C). The precision of absorbance measurement is above 0.001.
6.4 Reagent Blank
6.4.1 Use the designated blank samples to test the reagents (kits). At the main
wavelength of the test, record the absorbance (A1) at the start of the test and the
absorbance (A2) after about 5 min (t). The test result of A2 is the measured value of the
6.5 Analytical Sensitivity
Use samples with already-known concentration or activity to test the reagents (kits);
record the absorbance change generated under the specified parameters of the
reagents (kits). Convert it to the difference in absorbance (A) of n units, or, the change
rate of absorbance (A/min) of n units, which shall comply with the requirements of 5.4.
6.6 Linearity Range
6.7 Precision of Measurement
6.7.1 Repeatability
Under repeatability conditions, use the control materials to test the reagents (kits);
repeat the test for at least 10 times (n ≥ 10). Respectively calculate the average value
(x) and standard deviation (s) of the measured values. In accordance with Formula
(1), calculate the coefficient of variation (CV), which shall comply with the requirements
of 5.6.1.
6.7.2 Within-run difference between bottles
Use the control materials to respectively test 10 bottles with the same batch number.
In addition, calculate the average value (x1) and standard deviation (s1) of the 10
measured values.
6.7.3 Between-run difference
Use the control materials to respectively test reagents (kits) with 3 different batch
numbers. For each batch number, test 3 times. Respectively calculate the average
value xi (i = 1, 2, 3) of the 3 tests of each batch. In accordance with Formula (4) and
Formula (5), calculate the relative deviation (R), which shall comply with the
requirements of 5.6.3.
6.9 Stability
The following methods may be selected for the verification of stability.
7 Markings, Labels and Instructions for Use
7.1 General Requirements
The markings, labels and instructions for use shall comply with the following
requirements.
7.2 Markings and Labels of Outer Container
The markings and labels of the outer container shall include the following information.
7.3 Markings and Labels of Immediate Container
If the immediate container is also the outer container, then, the requirements of 7.2
also apply.
7.4 Instructions for Use
The instructions for use shall provide the following information.
8 Packaging, Transportation and Storage
8.1 Packaging
The packaging shall comply with the following requirements.
8.2 Transportation
Transport in accordance with the conditions specified in the contract.
8.3 Storage
Store in accordance with the specified conditions.
...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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