JJF 1389-2013Program of Pattern Evaluation of Digital Electrocardiographs (English PDF)

1 Scope (1)

2 References (1)

3 Overview (1)

4 Legal management requirements (1)

5 Measurement requirements (2)

6 General Requirements (3)

7 Type evaluation item list (4)

8 Pilot projects test methods and conditions (4)

9 Type, 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.