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JJF 1388-2013 English PDF

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JJF 1388-2013: Program of Pattern Evaluation of Digital Electroencephalogram Mapping and Brain Activity Mapping
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Basic data

Standard ID JJF 1388-2013 (JJF1388-2013)
Description (Translated English) Program of Pattern Evaluation of Digital Electroencephalogram Mapping and Brain Activity Mapping
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 37,324
Quoted Standard JJG 954-2000; JJG 1043-2008; 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 medical clinical diagnosis for digital EEG and EEG topographic instrument (hereinafter referred to as the digital EEG machine) type evaluation.

JJF 1388-2013: Program of Pattern Evaluation of Digital Electroencephalogram Mapping and Brain Activity Mapping


---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 Electroencephalogram Mapping People's Republic of China National Metrology Technical Specifications Digital EEG and EEG topographic map instrument Type Evaluation Outline Issued on. 2013-02-16 2013-05-16 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Digital EEG and EEG topographic map instrument Type Evaluation Outline Focal point. the National Radio Technical Commission metering Main drafting unit. Shanghai Institute of Measurement and Testing Participated in the drafting unit. Inner Mongolia Institute of Measurement and Testing The outline of the national commission of radio technical committee responsible for the interpretation of measurement The main drafters of this Memorandum. When Shen Hong (Shanghai Institute of Measurement and Testing) Qian Ding (Shanghai Institute of Measurement and Testing) Drafters participate. Yueyuan Peng (Inner Mongolia Metrology Institute) Huang Lijie (Shanghai Institute of Measurement and Testing)

table of Contents

Introduction (Ⅱ) 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 (1) 4.3 Other requirements (2) 5 measurement requirements (2) 5.1 EEG and BEAM section (2) 5.2 software features section (2) 6 General Requirements (2) 6.1 appearance and work requirements (2) 6.2 Climate requirements (3) 6.3 Mechanical environmental requirements (3) Ability to adapt to the requirements of the power supply voltage 6.4 (3) 6.5 Safety requirements (3) 6.6 EMC requirements (3) 7 type evaluation item list (4) 8 type evaluation test methods and conditions (5) 8.1 Legal Requirements Management (5) 8.2 metrological performance test (5) 8.3, and appearance check work (12) 8.4 Climate Environmental Testing (12) 8.5 Mechanical environmental testing (15) 8.6 safety test (17) 8.7 supply voltage adaptability test (17) 8.8 Electromagnetic compatibility tests (17) Results 9 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.

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