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JJF 1470-2014 English PDF

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JJF 1470-2014: Calibration Specification for Multiparameter Physiological Simulators
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Basic data

Standard ID JJF 1470-2014 (JJF1470-2014)
Description (Translated English) Calibration Specification for Multiparameter Physiological Simulators
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 25,219
Date of Issue 8/1/2014
Date of Implementation 11/1/2014
Quoted Standard GB 9706.25-2005
Regulation (derived from) AQSIQ Notice 2014 No. 89
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine
Summary This Standard applies to multiple physiological parameters simulated instrument calibration.

JJF 1470-2014: Calibration Specification for Multiparameter Physiological Simulators

---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 Multiparameter Physiological Simulators People's Republic of China National Metrology Technical Specifications Multi-parameter simulation Calibration physiological norm Issued on. 2014-08-01 2014-11-01 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Multi-parameter simulation Calibration physiological norm Focal point. the National Radio Technical Commission metering Drafted by. General Logistics Department of Health Drug and Instrument Control China Institute of Metrology Army Medical Research Center, Test Measurement This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement The main drafters of this specification. Wu Wenjun (General Logistics Department of the Ministry of Health Drug and Instrument Control) Li Yong snow (Army Medical Research Test Center measured) LIU Ke (China Institute of Metrology) Paragraph Xin'an (General Logistics Department of the Ministry of Health Drug and Instrument Control) Drafters participate. He Zhao (China Institute of Metrology) WU Jian-gang (General Logistics Department of the Ministry of Health Drug and Instrument Control)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) 3.1 The term (1) 3.2 units of measurement (1) 4 Overview (1) 5 Metrological characteristics (2) 5.1 ECG signal amplitude (2) 5.2 Heart rate (2) 5.3 Respiratory base impedance (2) 5.4 analog blood pressure signals (2) 5.5 cardiac output analog signals (2) 5.6 analog temperature signal (2) 5.7 Reference Waveform (2) Calibration Condition 6 (2) 6.1 environmental conditions (2) 6.2 standards and other measuring devices (2) 7 calibration items and calibration methods (3) 7.1 ECG signal amplitude (3) 7.2 Heart rate (4) 7.3 Respiratory impedance base (4) 7.4 analog blood pressure signals (5) 7.5 cardiac output analog signals (5) 7.6 temperature analog signals (6) 7.7 Reference Waveform (7) 8 calibration results expression (7) 8.1 Calibration records (7) 8.2 Calibration process results (7) 9 Recalibration interval (8) Appendix A calibration record format (9) Appendix B Calibration Certificate page format (12) Appendix C Measurement Uncertainty Example (15)

Introduction

This specification based JJF 1071-2010 "National Calibration Specifications writing rules", JJF 1059.1-2012 "Evaluation and Expression of Uncertainty in Measurement" establishment. This specification more physiological parameters of a typical analog instrument metrological characteristics with reference to the domestic market mainstream brands Technical Specifications determine. The specification for the first time to develop. Multi-parameter simulation Calibration physiological norm

1 Scope

This instruction applies to multi-parameter physiological simulation instrument calibration. 2. References This specification refers to the following documents. GB 9706.25-2005 Medical electrical equipment - Part 2-27. ECG monitoring equipment safety requirements 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 terminology and units of measurement

3.1 Terms 3.1.1 Multi-parameter physiological simulator multiparametersimulators Simulated human ECG, respiration, invasive blood pressure, cardiac output and medical testing equipment, body temperature and other physiological parameters, the main Parameters to be used for multi-parameter monitors and other medical equipment for testing. Lead lead [3.1.2] GB 9706.25-2005,2.102 Electrodes for ECG recording of a connection. 3.1.3 arrhythmia arrhythmia An exception occurred site of origin of heart rate, cardiac frequency and rhythm and conduction. 3.1.4 sinus sinusrhythm Electrical impulses emitted by the heart rhythm caused by sinus node activity. 3.2 units of measurement Units of measurement and reference ECG waveform amplitude is mV, the reference waveform frequency unit Hz; respiratory group Base impedance measurement unit is generally Ω.

4 Overview

Multi-parameter physiological simulator is mainly used for multi-parameter patient quality control and technical training monitor can output sine Wave, square wave and triangular wave reference waveform, and can simulate human ECG, respiration, invasive blood pressure, cardiac output, body temperature And many other electrophysiological parameters. Various waveforms required by the digital to analog converter and physiological signals generated by the input signal amplitude and frequency Into the digital control. ECG signal generated by the microcontroller control DAC, via a resistor network attenuated by a guide Union Distribution network output; analog signals through analog breathing respiratory impedance changes, with ECG output; blood pressure Analog signal generated by the resistive bridge sensors, and the applied voltage is proportional to the excitation; cardiac output analog signals using heat The relationship between resistance and temperature-sensitive indirect simulation; analog temperature thermistor resistance value at a specified temperature Simulation.

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