JJG 714-2012_English: PDF (JJG714-2012)
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Verification Regulation of Blood Cell Analyzers
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JJG 714-2012
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Standards related to: JJG 714-2012
| Standard ID | JJG 714-2012 (JJG714-2012) | | Description (Translated English) | Verification Regulation of Blood Cell Analyzers | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A61 | | Classification of International Standard | 17.020 | | Word Count Estimation | 15,116 | | Older Standard (superseded by this standard) | JJG 714-1990 | | Quoted Standard | YY/T 0653-2008 | | Drafting Organization | China Institute of Metrology | | Administrative Organization | National Clinical Measurement Technical Committee | | Regulation (derived from) | AQSIQ Announcement No. 96 of 2012 | | Issuing agency(ies) | State Administration of Quality Supervision, Inspection and Quarantine | | Summary | This standard applies to the blood cell analyzer initial verification, testing and use of follow-up checks. | JJG 714-2012
JJG
METROLOGICAL VERIFICATION REGULATION
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing JJG 714-1990
Verification Regulation of Blood Cell Analyzers
ISSUED ON. JUNE 18, 2012
IMPLEMENTED ON. DECEMBER 18, 2012
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Verification Regulation of Blood Cell Analyzers
Administrative organization. National Technical Committee of Clinical Medicine
Metrology
Main drafting organization. China National Institute of Metrology
Participating drafting organizations. Beijing Institute of Metrology and Testing;
Qingdao Institute of Metrology and Testing
This Regulation shall be interpreted by the National Technical Committee of
Clinical Medicine Metrology.
Table of Contents
1 Scope ... 5
2 Normative References ... 5
3 General ... 5
4 Metrological Performance Requirements ... 6
5 General Technical Requirements ... 6
6 Control of Measuring Devices ... 6
7 Handlings of Verification Results ... 9
8 Verification Cycle ... 9
Annex A Verification Original Data Log Sheet ... 10
Annex B Format of Inner-Pages of Verification Certificate/Verification Result
Letter ... 13
Verification Regulation of Blood Cell Analyzers
1 Scope
This Regulation applies to the initial verification, subsequent verification and in-use
verification of blood cell analyzers.
2 Normative References
The following document is referenced in this Regulation.
YY/T 0653-2008, Hematology Analyzer
For dated references, only the edition dated applies to this document. For undated
references, the latest edition of the referenced documents (including all amendments)
applies to this Regulation.
3 General
Blood cell analyzers (hereinafter referred to as analyzers) are capable of measuring
the red blood cell count (RBC), white blood cell count (WBC), blood platelet count (PLT)
and hemoglobin concentration (HGB) in human blood, which are mainly used for blood
tests by hospitals and scientific research departments and other departments.
The measuring methods for the red blood cell count in the analyzers include electrical
impedance method, laser scattering method, fluorescent staining method and so on.
The method widely used is the electrical impedance method; gem hole is used as the
sensor; after the sensor absorbs a fixed quantity of blood cell specimen, the blood cell
count is converted into the corresponding electrical pulse count. The electrical pulse is
amplified, voltage discriminated and shaped; then the blood cell count is determined
by measuring the electrical pulse count. The measurement of hemoglobin
concentration is generally carried out in accordance with the colorimetric principle; the
photoelectric element is used as the sensor; the sensor converts the variation of
hemoglobin concentration into the variation of the corresponding voltage signal; the
hemoglobin concentration is determined by measuring the variation of voltage after the
voltage signal goes through amplification operation.
The apparatus consist of mechanical system, electrical system, testing system and
control system and so on.
apparatus to preheat them; preset all switches and rotary knobs. The apparatus are
verified in accordance with the routine procedures if their self-inspection is normal. For
the apparatus having mode selection functions, set them to the whole blood
measurement mode. Reagents, which are from the manufacturer or whose
effectiveness can be proved, shall be used for the apparatus.
6.4.3 Blank value verification
Take an appropriate amount of apparatus blank diluent to pour into a clean measuring
cup; repeat the measurement for 4 times. Discard the measured value for the first time;
record the maximum values of the other 3 measured results, i.e. the blank values of
RBC, WBC, PLT, HGB.
6.4.4 Carryover verification
Select one kind of standard substances of high and low values; mix up before use. In
accordance with the sequence from high values to low values, carry out measurement
continuously for 3 times. The measured values are respectively i1, i2, i3 and j1, j2, j3.
Calculate the carryovers of RBC, WBC, PLT and HGB in accordance with Formula (1).
where,
CO—the carryover;
i3—the value of standard substance of a high value measured for the third time;
j1—the value of standard substance of a low value measured for the first time;
j3—the value of standard substance of a low value measured for the third time.
6.4.5 Verification of indication error
Take 3 ~ 5 kinds of blood cell standard substances of different concentrations within
the commonly-used measuring range of the apparatus (take 5 kinds for the first
verification); carry out measurement continuously for 5 times after mixing up
respectively; calculate respectively the relative error ΔT of indicating value of the
apparatus in accordance with Formula (2); take ΔT having the maximum absolute
value as the verification results of the indication error of RBC, WBC, PLT and HGB of
the apparatus.
where,
Ts—the standard value of standard substance;
Annex B
Format of Inner-Pages of Verification Certificate/Verification Result
Letter
B.1 Format of the second page of verification certificate/verification result letter
Certificate No. xxxx - xxxx
Verification body authorization instructions.
Environmental conditions and site for verification
Temperature. °C Site.
Relative humidity. % Others.
Metrological standard apparatus used for verification
Name Measuring range
Uncertainty/accuracy
grade/maximum
allowable error
Metrological
standard
certificate no.
Valid until
Standard instruments used for verification
Name Measuring range
Uncertainty/accuracy
grade/maximum
allowable error
Metrological
standard
certificate no.
Valid until
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