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JJF 1383-2012 English PDF

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JJF 1383-2012: Calibration Specification for Portable Blood Glucose Meters
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
JJF 1383-2012	English	369	Add to Cart	3 days [Need to translate]	Calibration Specification for Portable Blood Glucose Meters	Valid	JJF 1383-2012

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Basic data

Standard ID	JJF 1383-2012 (JJF1383-2012)
Description (Translated English)	Calibration Specification for Portable Blood Glucose Meters
Sector / Industry	Metrology & Measurement Industry Standard
Word Count Estimation	16,125
Quoted Standard	JJF 1001-2011; JJF 1059-1999; GB 6682-2008; GB/T 19634-2005; WS/T 226-2002
Regulation (derived from)	AQSIQ Announcement No. 212 of 2012
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine
Summary	This standard provides a portable blood glucose analyzer metrological characteristics, calibration conditions and calibration methods. This specification is for in vitro monitoring of blood sugar levels portable blood glucose analyzer.

JJF 1383-2012: Calibration Specification for Portable Blood Glucose Meters

---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.
Calibration Specification for Portable Blood Glucose Meters People's Republic of China National Metrology Technical Specifications Portable blood glucose analyzer calibration specification Issued on. 2012-12-21 2013-03-21 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Portable blood glucose analyzer calibration specification Focal point. the National Technical Committee on Clinical Measurement Main drafting unit. Hangzhou quality technical supervision detection hospital China Institute of Metrology Guangzhou Institute of Measurement and Detection Participated in the drafting unit. Ningbo Institute of Measurement and Testing Shanghai, a real medical equipment Co., Ltd. This specification commissioned the National Technical Committee of Clinical Medicine is responsible for interpretation of measurement The main drafters of this specification. Jiang Xueping (Hangzhou Quality and Technical Supervision and Inspection Institute) Xu Bei (China Institute of Metrology) Shao Lei (Hangzhou Quality and Technical Supervision and Inspection Institute) Huliang Yong (Guangzhou Institute of Measurement and Detection) Drafters participate. Yushan Cheng (Ningbo Institute of Measurement and Testing) Zhu Renming (Shanghai, a real medical equipment Co., Ltd.)

1 Scope (1) 2. References (1) 3 Terms and Definitions (1) 3.1 carryover (1) 4 Overview (1) 5 Metrological characteristics (1) 5.1 indication error (1) 5.2 Measurement repeatability (2) 5.3 linearity error (2) 5.4 carryover (2) Calibration Condition 6 (2) 6.1 environmental conditions (2) 6.2 standards and other measuring equipment (2) 7 calibration items and calibration methods (2) 7.1 appearance and working properly check (2) 7.2 preparation before calibration (2) 7.3 Indication error (2) 7.4 Measurement repeatability (3) 7.5 Linearity error (3) 7.6 carryover (3) 8 calibration results expression (4) 9 Recalibration interval (4) Appendix A portable blood glucose analyzer calibration record format (5) Appendix B portable blood glucose analyzer calibration certificate (within the page) format (6) Appendix C portable blood glucose analyzer Indication Error of Measurement Uncertainty (7) Portable blood glucose analyzer calibration specification

1 Scope

This specification defines the metrological characteristics of a portable blood glucose analyzer calibration conditions and calibration methods. The specification for the body External monitoring of blood glucose content portable blood glucose analyzer. 2. References JJF 1001-2011 common measurement terms and definitions JJF 1059-1999 Measurement Uncertainty and representation GB 6682-2008 analytical laboratory use specifications and test methods GB/T 19634-2005 vitro diagnostic test systems for self blood glucose monitoring system General technical requirements WS/T 226-2002 portable blood glucose meter blood glucose measurement guide For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.

3 Terms and Definitions

3.1 carryover carry-overrate By the measurement system will carry a test sample reaction to detect the analyte another sample of the reaction discrete amount by This error affected the performance of another quantity of the test sample. Usually taken given the known nominal value of high and low sample Measured value of the sample cross many times, calculated using a specific formula.

4 Overview

Portable blood glucose analyzer according to the measure of sugar technology can be divided electrochemical test and the light reflective technology test two categories. The former is an enzyme reacts with glucose to produce an electronic current through the counting device, read the number of electrons; microcontroller according to Correspondence between the current size and the blood glucose concentration in the blood glucose concentration is calculated and displayed. The latter is by Contact with the blood test reagent block blood glucose test strips, and color change agent blocks react portable blood glucose By irradiating the test wells analyzer reagent strip block strip on the platform, and measuring the reflected light, thereby obtaining a reagent strip Built-in microcontroller based on the color of the corresponding block and reagent strip blood glucose concentration; changes in color blocks Relationship between blood glucose concentration values calculated and displayed. Portable blood glucose analyzer by the analysis system, microcontrollers, data storage, LCD display, data output interface Ports and other components. Rapid measurement portable blood glucose analyzer is mainly used in fresh capillary whole blood glucose content can also be used Venous whole blood, rapid measurement of serum (plasma) of the glucose content.

5 Metrological characteristics

5.1 Indication error

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