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Program of Pattern Evaluation of Digital Electrocardiographs
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JJF 1389-2013
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Basic data Standard ID | JJF 1389-2013 (JJF1389-2013) | Description (Translated English) | Program of Pattern Evaluation of Digital Electrocardiographs | Sector / Industry | Metrology & Measurement Industry Standard | Classification of Chinese Standard | A56 | Classification of International Standard | 17.220 | Word Count Estimation | 45,413 | Quoted Standard | JJG 1041-2008; GB/T 14710-2009; GB/T 17626.2-2006; GB/T 17626.4-2008; GB/T 17626.5-2008; GB/T 17626.11-2008 | Regulation (derived from) | ?State AQSIQ Announcement 2013 No. 28; | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine | Summary | This standard applies to the evaluation of digital ECG machine type. Not available for analog ECG, vector ECG pattern evaluation and other special-purpose dedicated ECG machine. |
JJF 1389-2013: Program of Pattern Evaluation of Digital Electrocardiographs---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.
Program of Pattern Evaluation of Digital Electrocardiographs
People's Republic of China National Metrology Technical Specifications
Digital ECG machine type evaluation outline
Issued on. 2013-02-16
2013-05-16 implementation
The State Administration of Quality Supervision, Inspection and Quarantine released
Digital ECG machine type evaluation outline
hs
Focal point. the National Radio Technical Commission metering
Main drafting unit. Beijing Institute of Metrology detection
Participated in the drafting unit. China Institute of Metrology
General Logistics Department of the Ministry of Health Drug and Instrument Control
This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement
The main drafters of this Memorandum.
Wen Cummins (Beijing Institute of Metrology detection)
Zhangjian Ling (Beijing Institute of Metrology detection)
Drafters participate.
Bian Xin (China Institute of Metrology)
Jia Jiange (General Logistics Department of the Ministry of Health Drug and Instrument Control)
Gao Yang (Beijing Institute of Metrology detection)
table of Contents
Introduction (Ⅲ)
1 Scope (1)
2. References (1)
3 Overview (1)
4 legal management requirements (1)
4.1 Units of measurement requirements (1)
4.2 legal metrology requirements for marking and identification of measuring instruments (2)
4.3 Other requirements (2)
5 measurement requirements (2)
5.1 Calibration voltage (2)
5.2 input voltage range (2)
5.3 Resistance polarization voltage (2)
5.4 weighting coefficient error (2)
5.5 Internal noise level (2)
5.6 Waveform Recognition and amplitude - time parameter measurement (2)
5.7 Frequency Characteristics (2)
Time constant of 5.8 (2)
5.9 heart rate (HR) measurement error (3)
5.10 common mode rejection ratio (3)
6 General Requirements (3)
6.1 appearance and work of (3)
6.2 Functional requirements (3)
6.3 Climate requirements (3)
6.4 Mechanical environmental requirements (3)
6.5 Power adaptability (3)
6.6 EMC requirements (3)
7 type evaluation item list (4)
8 pilot projects test methods and conditions (4)
8.1 Legal Requirements Management (4)
8.2 metrological requirements (5)
8.3, and appearance check work (12)
8.4 functional requirements (12)
8.5 Climate Environmental Testing (12)
8.6 Mechanical environmental testing (13)
8.7 Power adaptability test (14)
8.8 Electromagnetic compatibility tests (14)
Type 9 Judgment principle results (22)
Appendix A standard ECG signal simulation waveform parameters (23)
Appendix B digital ECG machine type evaluation of the original records (33)
Introduction
This outline is a digital ECG machine type evaluation basis.
The preparation of the outline to JJG1041-2008 "digital ECG machine" GB/T 14710-2009 "Medical Electrical
Environmental requirements and test methods ", GB/T 17626.2-2006" Electromagnetic compatibility - Testing and measurement techniques - Electrostatic discharge
Immunity test ", GB/T 17626.4-2008" Electromagnetic compatibility Testing and measurement techniques - Electrical fast transient burst
Immunity test ", GB/T 17626.5-2008" Electromagnetic compatibility test and measurement technology surge (impact) immunity
Test "and GB/T 17626.11-2008" Electromagnetic compatibility Testing and measurement techniques - Voltage dips, short of
Off and voltage variations immunity tests "basis.
This outline is the first release.
Digital ECG machine type evaluation outline
1 Scope
The outline of the type evaluation type evaluation applied to digital ECG machine; does not apply to analog ECG, heart vector
Type evaluation electrographic machine and other special-purpose dedicated ECG machine.
2. References
This outline references the following documents.
JJG1041-2008 digital electrocardiograph
GB/T 14710-2009 medical electrical environmental requirements and test methods
GB/T 17626.2-2006 Electromagnetic compatibility - Testing and measurement techniques - Electrostatic discharge immunity test
GB/T 17626.4-2008 Electromagnetic compatibility - Testing and measurement techniques - Electrical fast transient burst immunity
test
GB/T 17626.5-2008 Electromagnetic compatibility - Testing and measurement techniques - Surge (impact) immunity test
GB/T 17626.11-2008 Electromagnetic compatibility Testing and measurement techniques - Voltage dips, short interruptions and voltage
Variations immunity tests
These documents contain provisions which through reference in this syllabus constitute provisions of this outline. For dated reference documents
Members, release date only applies to this outline, however, encourage the parties according to research whether this outline agreement
Use the latest versions of these files. For undated references, the latest edition (including all amendments
) Apply to this syllabus.
3 Overview
Digital ECG machine is a physiological electrical signals of the instrument used to record and display the heart activity generated.
Use digital ECG machine ECG electrodes to extract physiological signals from the body via the network input lead, lead selector
Into the preamplifier, a filter circuit, and then after A/D conversion into the control section, after digital processing, filtering, variable
After changing into the recording and display, which records and displays the ECG waveform. The block diagram shown in Figure 1.
Block diagram of Figure 1 digital electrocardiograph
4 legal management requirements
4.1 units of measurement requirements
Measuring instruments shall be the legal units of measurement.
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