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Calibration Specification for Multiparameter Physiological Simulators
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JJF 1470-2014
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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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