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JJF 1392-2013 English PDF

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JJF 1392-2013: Program of Pattern Evaluation of Ambulatory Electrocardiographs
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Standard similar to JJF 1392-2013

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Basic data

Standard ID JJF 1392-2013 (JJF1392-2013)
Description (Translated English) Program of Pattern Evaluation of Ambulatory Electrocardiographs
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 38,330
Quoted Standard JJG 1042-2008; 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 the following two types of dynamic (moving) pattern evaluation ECG machine: a) continuous recording, analysis of ECG and achieve full playback. Can be recorded, analysis or playback after recording by an independent workstation st

JJF 1392-2013: Program of Pattern Evaluation of Ambulatory Electrocardiographs

---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 Ambulatory Electrocardiographs People's Republic of China National Metrology Technical Specifications Dynamic (movable) ECG machine Type Evaluation Outline Issued on. 2013-02-16 2013-05-16 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Dynamic (movable) ECG machine Type Evaluation Outline hs Focal point. the National Radio Technical Commission metering Main drafting unit. Beijing Institute of Metrology detection Participated in the drafting. General Logistics Department of Health Drug and Instrument Control China Institute of Metrology This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement The main drafters of this specification. Wen Cummins (Beijing Institute of Metrology detection) Zhangjian Ling (Beijing Institute of Metrology detection) Drafters participate. Xue Li Yong (General Logistics Department of the Ministry of Health Drug and Instrument Control) He Zhao (China Institute of Metrology) Gao Yang (Beijing Institute of Metrology detection)

table of Contents

Introduction (Ⅲ) 1 Scope (1) 2. References (1) 3 Overview (1) 4 legal management requirements (2) 4.1 Units of measurement requirements (2) 4.2 legal metrology requirements for marking and identification of measuring instruments (2) 4.3 Other requirements (2) 5 measurement requirements (2) 5.1 Maximum input range (2) 5.2 tracings minimum sensitivity threshold (2) 5.3 Resistance polarization voltage (2) 5.4 Input impedance (2) 5.5 Sensitivity error (2) 5.6 sensitivity stability (2) 5.7 Calibration voltage (applies only to analog memory device to be examined) (2) 5.8 Frequency Response (3) 5.9 Overshoot (3) Hysteresis 5.10 (3) 5.11 timing error (only applicable to the event insertion means to be examined on a recorder) (3) 5.12 hard copy (printout or photo) tracings speed error (3) Interference between 5.13 (3) 5.14 common mode rejection ratio (3) 5.15 system noise level (3) 5.16 compliance and pacing pulse detection capability (3) 6 General Requirements (3) 6.1 appearance and work of (3) 6.2 Climate requirements (4) 6.3 Mechanical environmental requirements (4) 6.4 Power adaptability (4) 6.5 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 requirements (5) 8.3, and appearance check work (15) 8.4 Climate Environmental Testing (15) 8.5 Mechanical environmental testing (16) 8.6 Power adaptability test (16) 8.7 Electromagnetic compatibility tests (17) Type 9 Judgment principle results (25) Appendix A dynamic (movable) ECG machine type evaluation original record format (26)

Introduction

This outline is dynamic (movable) ECG machine type evaluation basis. The preparation of the outline to JJG1042-2008 "dynamic (movable) 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 - Testing and measurement techniques - Surge (Impact) immunity test "and GB/T 17626.11-2008" electromagnetic compatibility test and measurement technology voltage sags Drop, short interruptions and voltage variations immunity tests "basis. This outline is the first release. Dynamic (movable) ECG machine Type Evaluation Outline

1 Scope

This type of evaluation outline for the following two types of dynamic pattern evaluation (removable) ECG machine. a) continuous recording, analysis and electrocardiogram achieve full playback. It may be recorded after storage back to the stand-alone workstation Caving or recorded, analyzed simultaneously. b) continuous analysis but only a part of the record, does not provide full playback. 2. References This outline references the following documents. JJG1042-2008 dynamic (movable) 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 - 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

Dynamic (movable) ECG machine capable of continuously 24h or longer, three-channel recording in the patient's natural state Or multi-channel ECG signal by means of a computer for display, analysis and processing, find all kinds of arrhythmia and ST events Segment abnormalities, provide an important basis for clinical diagnosis and treatment. Dynamic (movable) ECG machine is usually divided into two types. a) for continuous recording and analytical dynamic (movable) ECG machine 1) Conventional dynamic (movable) ECG machine, the first recorded ECG signal, and then dividing by the individual workstation Analysis process; 2) real-time dynamic (movable) ECG, recorded and analyzed simultaneously. b) Continuous analysis but some recordable dynamic (movable) ECG machine 1) In the course of the entire ECG only on important events or specific ECG recording; 2) In the whole course of the real ECG recording ECG, but only generates time and amplitude compression formats

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