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JJF 1390-2013 English PDF

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JJF 1390-2013: Program of Pattern Evaluation of Electoroencephalographs
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Basic data

Standard ID JJF 1390-2013 (JJF1390-2013)
Description (Translated English) Program of Pattern Evaluation of Electoroencephalographs
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 44,426
Quoted Standard 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 specifies the evaluation criteria used in medical diagnosis analog EEG machine.

JJF 1390-2013: Program of Pattern Evaluation of Electoroencephalographs

---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 Electoroencephalographs People's Republic of China National Metrology Technical Specifications EEG machine type evaluation outline Issued on. 2013-02-16 2013-05-16 implementation The State Administration of Quality Supervision, Inspection and Quarantine released EEG machine type evaluation outline hs 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 China Institute of Metrology This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement Drafters of this specification. When Shen Hong (Shanghai Institute of Measurement and Testing) Qian Ding (Shanghai Institute of Measurement and Testing) Drafters participate. Ning Quan (Inner Mongolia Metrology Institute) He Zhao (China Institute of Metrology) Huang Lijie (Shanghai Institute of Measurement and Testing)

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 (1) 4.3 Other requirements (2) 5 measurement requirements (2) 5.1 Calibration voltage (amplitude internal calibrator) (2) Voltage measurement 5.2 (2) 5.3 the sensitivity (gain) (2) Interval 5.4 (2) 5.5 recording speed (2) 5.6 Record lag (2) 5.7 GB (2) 5.8 overshoot (2) Time constant of 5.9 (2) 5.10 Frequency Characteristics (2) 5.11 filter (2) 5.12 base line width (2) 5.13 Baseline Wander (2) 5.14 Noise (2) 5.15 common mode rejection ratio (3) 5.16 polarization voltage resistance (3) 5.17 input impedance (3) 6 General Requirements (3) 6.1 appearance and work requirements (3) 6.2 Climate requirements (3) 6.3 Mechanical environmental requirements (3) 6.4 supply voltage adaptability requirements (4) 6.5 Safety requirements (4) 6.6 EMC requirements (4) 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 (6) 8.3, and appearance check work (16) 8.4 Climate Environmental Testing (17) 8.5 Mechanical environmental testing (19) 8.6 safety test (21) 8.7 supply voltage adaptability test (21) 8.8 Electromagnetic compatibility tests (21) Type 9 Judgment principle (28) Results Appendix A pattern evaluation project recording format (29)

Introduction

This outline is based on JJG1043-2008 "EEG" technical indicators and write. Environmental testing of this syllabus is GB/T 14710-2009 "medical electrical environmental requirements and test methods" and reference Prepared. EMC Part reference GB/T 17626.2-2006, GB/T 17626.5-2008 and other relevant countries Standards development. This outline 5-9 chapter includes EEG measurement requirements, technical requirements, test conditions, pilot projects and Test methods and results determined principles. Technical requirements, test conditions, test items and test methods specified in this syllabus and who does not JJG1043-2008 Same to this Memorandum shall prevail. EEG machine type evaluation outline

1 Scope

This type evaluation type evaluation outline (hereinafter referred to as the Outline) for medical diagnostic analog EEG machine. 2. References This outline references the following documents. 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 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

EEG is the human brain electrical activity signal is amplified and waveform trace certain records obtained by the Instrument, it is mainly by the input circuit, amplifiers and recorders and other components. Its main function is as a clinical diagnosis of Brain and nervous system diseases provide the basis.

4 legal management requirements

4.1 units of measurement requirements EEG machine should adopt legal units of measurement. 4.2 legal metrological requirements for marking and measuring instruments logo Must be marked with signs and legal metrology measuring instruments and other parts clearly identified in the EEG machine nameplate or panel, its standard Chi, number and description must be clear, solid and reliable. 4.2.1 legal metrology signs generally include the following. a) measurement equipment manufacturing license logo and number (test digital EEG machine should stay out of the corresponding position). b) measurement equipment type approval mark and number (EEG test may be left out of the corresponding position; this item is not mandatory Provisions). c) product quality stamps certificate (this can be provided separately from the body and measuring instruments).

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