JJF 1388-2013Program of Pattern Evaluation of Digital Electroencephalogram Mapping and Brain Activity Mapping (English PDF)

1 Scope (1)

2 References (1)

3 Overview (1)

4 Legal management requirements (1)

5 Measurement requirements (2)

6 General Requirements (2)

7 Type evaluation item list (4)

8 Type evaluation test methods and conditions (5)

9 Results, type evaluation of decision rules (24)

Appendix A pattern evaluation project recording format (25)

Introduction

This outline is based on JJG954-2000 "digital EEG and EEG topographic map instrument" in the technical indicators, at the same time part of JJG1043-2008 "EEG" technical indicators and write.

Environmental testing of this syllabus is GB/T 14710-2009 "medical electrical environmental requirements and test methods" written reference.

EMC Part reference GB/T 17626.2-2006, GB/T 17626.5-2008 and other relevant national standards People's Republic of China established.

5 to 9 This outline includes the EEG measurement requirements, technical requirements, test conditions, pilot projects and Test methods and results determined principles.

The technical requirements specified in this syllabus, test conditions, test items and test methods and Van with JJG954-2000 JJG1043-2008 different to this Memorandum shall prevail.

Digital EEG and EEG topographic map instrument Type Evaluation Outline

1 Scope

This type of evaluation outline (hereinafter referred to as the Outline) suitable for medical clinical diagnosis of digital EEG and EEG topographic map instrument (hereinafter referred to as the digital EEG) of pattern evaluation.

2. References

This outline references the following documents.

JJG954-2000 digital EEG and EEG topographic map instrument JJG1043-2008 EEG 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 references, Only dated edition applies to this syllabus, however, encouraged to whether the latest versions of these files according to the parties that this outline agreement.

For undated references, the latest edition (including any amendments) applies to this outline.

3 Overview

Digital EEG machine is the biological activity of human tissue analog electrical signals generated by the brain through the input circuit, an amplifier, Data acquisition and analog to digital converter, etc., and converted into digital storage, digital stored after treatment playback display or print out the time-domain EEG, as a medical diagnosis based on clinical brain system diseases.

EEG topographic map instrument is to increase the EEG signal in the frequency domain analysis function in the digital EEG machine, and the results of the analysis to the power spectrum, in the form of brain electrical activity mapping displayed or printed.

4 legal management requirements 4.1 units of measurement requirements Digital EEG machine should adopt legal units of measurement.

4.2 legal metrological requirements for marking and measuring instruments logo it must be marked with signs and legal metrology measuring instruments and other parts clearly identified in the digital EEG machine nameplate or panel.