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JJF 1391-2013 English PDF

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JJF 1391-2013: Program of Pattern Evaluation of Electrocardiograph
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Basic data

Standard ID JJF 1391-2013 (JJF1391-2013)
Description (Translated English) Program of Pattern Evaluation of Electrocardiograph
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 37,390
Quoted Standard JJG 543-2008; 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 real-time measurement of body surface potential heart-channel analog, type evaluation of multi-channel ECG machine.

JJF 1391-2013: Program of Pattern Evaluation of Electrocardiograph

---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 Electrocardiograph People's Republic of China National Metrology Technical Specifications ECG machine type evaluation outline Issued on. 2013-02-16 2013-05-16 implementation The State Administration of Quality Supervision, Inspection and Quarantine released ECG machine type evaluation outline Focal point. the National Radio Technical Commission metering Main drafting unit. Beijing Institute of Metrology detection Participated in the drafting unit. Inner Mongolia Institute of Measurement and Testing China Institute of Metrology This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement The main drafters of this specification. Zhangjian Ling (Beijing Institute of Metrology detection) Wen Cummins (Beijing Institute of Metrology detection) Drafters participate. Ning Quan (Inner Mongolia Metrology Institute) Tao Yi (China Institute of Metrology) Huang Yan (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 (amplitude internal calibrator) (2) Voltage measurement 5.2 (2) Interval 5.3 (2) 5.4 GB (2) 5.5 Frequency Characteristics (2) 5.6 Resistance polarization voltage (2) 5.7 Noise (2) 5.8 common-mode rejection ratio (2) 5.9 the sensitivity (gain) (2) Recording speed 5.10 (3) 5.11 record hysteresis (3) 5.12 overshoot (3) Time constant of 5.13 (3) 5.14 base line width (3) 5.15 baseline drift (3) 5.16 input impedance (3) 6 General Requirements (3) 6.1 appearance and working properly check (3) 6.2 Climate requirements (3) 6.3 Mechanical environmental requirements (3) 6.4 Power adaptability (3) 6.5 EMC requirements (3) 7 type evaluation item list (4) 8 pilot projects test methods and conditions (5) 8.1 Legal Requirements Management (5) 8.2 metrological requirements (5) 8.3, and appearance check work (14) 8.4 Climate Environmental Testing (14) 8.5 Mechanical environmental testing (15) 8.6 Power adaptability test (16) 8.7 Electromagnetic compatibility tests (16) Type 9 Judgment principle (24) Results Appendix A simulation model electrocardiogram evaluation formula original record format (25)

Introduction

This outline is simulated ECG machine type evaluation basis. The preparation of the outline to JJG543-2008 "ECG", GB/T 14710-2009 "Medical Electrical Environment 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 Test "and GB/T 17626.11-2008" electromagnetic compatibility test and measurement techniques - Voltage dips, short interruptions and Voltage variations immunity tests "basis. This outline is the first release. ECG machine type evaluation outline

1 Scope

This type of evaluation framework for real-time measurement of body surface potential cardiac analog single-channel, multi-channel electrocardiograph The pattern evaluation. 2. References This outline references the following documents. JJG543-2008 ECG 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

ECG tracings is heart tissue activity of biological signals generated by the instruments for clinical diagnosis and for medical Biological wave, which is mainly composed of an input circuit, amplifiers and recorders and other components, divided into single-channel ECG And multi-channel electrocardiograph. Single Channel ECG electrocardiogram by the way is an analog linear amplifier and recorder composition Machine; multi-channel ECG machine is a multi-channel linear amplifier and an analog recording device consisting of ECG machine. Block diagram of Figure 1 ECG machine

4 legal management requirements

4.1 units of measurement requirements

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