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JJF 1860-2020 English PDF

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JJF 1860-2020: Calibration Specification for Defibrillator Analyzers
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JJF 1860-2020509 Add to Cart 4 days Calibration Specification for Defibrillator Analyzers Valid

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Basic data

Standard ID: JJF 1860-2020 (JJF1860-2020)
Description (Translated English): Calibration Specification for Defibrillator Analyzers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A55
Word Count Estimation: 22,254
Date of Issue: 2020-09-11
Date of Implementation: 2021-03-11
Regulation (derived from): Announcement No. 40 (2020) of the State Administration for Market Regulation
Issuing agency(ies): State Administration for Market Regulation

JJF 1860-2020: Calibration Specification for Defibrillator 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.
Calibration Specification for Defibrillator Analyzers National Metrology Technical Specifications of the People's Republic of China Calibration Specification for Defibrillator Analyzer 2020-09-11 released 2021-03-11 implementation Issued by the State Administration for Market Regulation Calibration Specification for Defibrillator Analyzer Focal point. National Technical Committee of Clinical Medicine Metrology Main drafting unit. Beijing Institute of Metrology and Testing Science China Institute of Metrology Participated in the drafting. Joint Logistics Support Force Drug Instrument Supervision and Inspection Station This specification entrusts the National Clinical Medical Metrology Technical Committee to be responsible for interpretation The main drafters of this specification. Zeng Dehua (Beijing Institute of Metrology and Testing Science) Liu Li (Beijing Institute of Metrology and Testing Science) Shao Haiming (Chinese Academy of Metrology) Participating drafters. Wu Wenjun (General Station for Supervision and Inspection of Drug Equipment of Joint Logistics Support Force) Zhao Jianhui (Beijing Institute of Metrology and Testing Science) Jia Jiange (General Station for Supervision and Inspection of Drug Equipment of Joint Logistics Support Force) Zhao Wei (China Institute of Metrology)

table of Contents

Introduction (Ⅱ) 1 scope (1) 2 Reference documents (1) 3 Term (1) 4 Overview (1) 5 Measurement characteristics (1) 5.1 Load resistance (1) 5.2 QRS wave(2) 5.3 Sine wave(2) 5.4 Release energy (2) 6 Calibration conditions (2) 6.1 Environmental conditions (2) 6.2 Measurement standards and other equipment (2) 7 Calibration items and calibration methods (3) 7.1 Appearance and normal working inspection (3) 7.2 Load resistance (3) 7.3 QRS wave heart rate (4) 7.4 Sine wave frequency (4) 7.5 Amplitude frequency characteristics (5) 7.6 Sine wave distortion (5) 7.7 Indication error of released energy (5) 7.8 Repeatability of indication error of released energy (8) 8 Calibration result expression (8) 9 Re-calibration interval (9) Appendix A Format of the original calibration record (recommended) (10) Appendix B Internal page of calibration certificate (recommended) format (13) Appendix C Example of Uncertainty Evaluation of Indication Error in the Measurement of Release Energy by Defibrillator Analyzer (15)

Introduction

This specification is based on JJF 1071-2010 "Rules for the Compilation of National Metrology and Calibration Specifications", JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Expression" was formulated. The main indicators of this specification refer to JJG1016-2006 "Electrocardiogram Monitor Verifier", JJF 1149-2014 "Calibration Specification for Cardiac Defibrillators", GB 9706.8-2009 "Medical Electrical Equipment Part 2-4.Cardiac Defibrillators Safety specific requirements. This specification is released for the first time. Calibration Specification for Defibrillator Analyzer

1 Scope

This specification applies to the calibration of defibrillator analyzers (including defibrillator test or calibration devices).

2 Reference documents

This specification refers to the following documents. JJG1016-2006 ECG monitor calibrating instrument JJF 1149-2014 Cardiac Defibrillator Calibration Specification GB 9706.8-2009 Medical electrical equipment Part 2-4.Particular requirements for the safety of cardiac defibrillators For dated reference documents, only the dated version applies to this specification; for undated reference documents, The latest version (including all amendments) is applicable to this specification.

3 term

3.1 Cardiac Defibrillator Apply electrical pulses to the patient's skin (external electrodes) or exposed heart (internal electrodes) through electrodes. The medical electrical equipment used to defibrillate the heart of a patient is called a defibrillator for short. [GB 9706.8-2009,2.1.101] 3.2 Cardiac Defibrillator Monitor A defibrillator with ECG monitoring function can obtain and display patient ECG signals through defibrillation electrodes or ECG monitoring lead electrodes, Referred to as defibrillator monitor. 3.3 Release energy The energy released by the electrodes of the defibrillator and dissipated in the patient or the resistance of the specified resistance. [GB 9706.8-2009,2.12.101]

4 overview

The defibrillator analyzer is a special measurement and analysis instrument used to calibrate the defibrillator and defibrillator monitor. The defibrillator analyzer detects the voltage applied to the load resistance that simulates the human body impedance when the defibrillator is discharged And (or) current, measure the released energy of the defibrillator, and can generate QRS waveforms and sinusoidal waveforms that simulate human ECG, Used to test the defibrillation monitoring performance of the defibrillation monitor. The defibrillator analyzer is mainly composed of load resistance, attenuation resistance network, sampling circuit, analog/digital converter, waveform generator, It is composed of microprocessor and display components.

5 Metrological characteristics

5.1 Load resistance Non-inductive resistance, resistance value 50Ω, maximum allowable error. ±1%.
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