JJG 464-2011 English PDF

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JJG 464-2011: Verification Regulation of Semiautomatic Clinical Chemistry Analyzers
Status: Valid

JJG 464: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJG 464-2011	399	Add to Cart	3 days	Verification Regulation of Semiautomatic Clinical Chemistry Analyzers	Valid
JJG 464-1996	479	Add to Cart	4 days	Verification Regulation of Ceinical Chemistry Analyzer	Obsolete

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Basic data

Standard ID: JJG 464-2011 (JJG464-2011)
Description (Translated English): Verification Regulation of Semiautomatic Clinical Chemistry Analyzers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A61
Word Count Estimation: 17,190
Date of Issue: 2011-11-30
Date of Implementation: 2012-05-30
Older Standard (superseded by this standard): JJG 464-1996
Regulation (derived from): State Administration of Quality Supervision, Inspection and Quarantine of 2011 No. 202
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This standard applies to semi-automatic biochemical analyzer's initial verification, testing and use of follow-up checks. Type evaluation and prototype tests for measuring performance test may refer to.

JJG 464-2011: Verification Regulation of Semiautomatic Clinical Chemistry Analyzers

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Verification Regulation of Semiautomatic Clinical Chemistry Analyzers State verification procedures People's Republic of China Semi-automatic biochemical analyzer Issued on. 2011-11-30 2012-05-30 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Semi-automatic biochemical analyzer test procedures zers Replacing JJG 464-1996 The regulations by the State Administration of Quality Supervision, Inspection and Quarantine approved on November 30, 2011, and from From May 30, 2012 implementation. NFP. National Technical Committee biometric The main drafting units. China Institute of Metrology Participated in the drafting unit. Tianjin Institute of Labor Hygiene and Occupational Tianjin Institute of Pharmaceutical Sciences Tianjin Central Scientific Instruments Company This procedure entrust the National Technical Committee is responsible for interpreting biometric The main drafters of this procedure. Xiebao Min (China Institute of Metrology) Drafters participate. Yan-let (Tianjin Institute of Occupational Health) Wang Qian (Tianjin Institute of Pharmaceutical Sciences) Single Kwong Chi (Tianjin Central Scientific Instrument Company)

table of Contents

1 Scope (1) 2 Overview (1) 3 metering performance requirements (1) 4 General Requirements (3) 4.1 Appearance and initial inspection (3) 4.2 Insulation resistance (3) 5 control of measuring instruments (3) 5.1 test conditions (3) 5.2 Verification Project (3) 5.3 Verification Methods (4) 5.4 Verification Results Processing (6) 5.5 test cycle (6) A method for the preparation of standard solution of sodium nitrite appendix (7) Preparation method B standard solution of cobalt chloride appendix (8) Appendix C test recording format (9) Appendix D test certificate-page format (11) Appendix E test results in the notice page format (12) Semi-automatic biochemical analyzer test procedures

1 Scope

The order applies to semi-automatic biochemical analyzer's initial verification, use and subsequent verification check. Type evaluation and Prototype tests relating to the measurement performance test can be implemented by reference.

2 Overview

Semi-automatic biochemical analyzer (hereinafter referred to as the analyzer), refers to the analysis part of the operation done manually, While another part of the operation by the analyzer automatically. Analyzer special UV, visible region produced according to the test substance Intrinsic absorption spectrum to comply with Lambert - Beer (Lambert-Beer) law principles, unknown concentration of sample with a known concentration Standards of comparing the measured substance or quantitative analysis based on the molar extinction coefficient method. Lambert - Beer Law expressed as follows. A = -lgτ = abc Where. A --- substances absorbance; τ --- substance transmittance; Absorption coefficient of a --- substances; b --- optical path length; c --- concentration of the substance. Part of the analyzer is mainly composed of a light source, a monochromator, absorption cell, detector, data processing.

3 metering performance requirements

Spectral analyzer according to different types of principles into two categories. The first category is a spectroscopic (prism or grating), second Class filter type (interference filters or absorption filters). Each class spectral analyzer according to the principles of the technical level is not The same is divided into A, B, C three. Metrological performance analyzer requirements as shown in Table 1 and Table 2. Table 1 analyzer measurement performance requirements (wavelength) Class level Wavelength Range / nm Wavelength indication Error/nm Repeatability / nm Center wavelength Error/nm Bandwidth/nm 340 to 700 ± 1 0.5 ± 3 1.5 ± 5 2.5 340 to 700 ± 2 ≤10 ± 4 ≤12 ± 6 ≤15 ......

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