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Program of Pattern Evaluation of Electoroencephalographs
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JJF 1390-2013
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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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