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JJF 1393-2013 English PDF

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JJF 1393-2013: Program of Pattern Evaluation of Electrocardiographic Monitors
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Basic data

Standard ID JJF 1393-2013 (JJF1393-2013)
Description (Translated English) Program of Pattern Evaluation of Electrocardiographic Monitors
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 30,391
Quoted Standard JJG 760-2003; 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 ECG (including multi-parameter monitor ECG ECG partial guardianship and cardiac defibrillator monitor part of) the type evaluation.

JJF 1393-2013: Program of Pattern Evaluation of Electrocardiographic Monitors

---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 Electrocardiographic Monitors People's Republic of China National Metrology Technical Specifications ECG pattern evaluation outline Issued on. 2013-02-16 2013-05-16 implementation The State Administration of Quality Supervision, Inspection and Quarantine released ECG pattern evaluation outline hicMonitors Focal point. the National Radio Technical Commission metering Main drafting unit. Beijing Institute of Metrology detection 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 The main drafters of this specification. Gao Yang (Beijing Institute of Metrology detection) Wen Cummins (Beijing Institute of Metrology detection) Drafters participate. Huang Yan (Beijing Institute of Metrology detection) Liu Feng (Inner Mongolia Metrology Institute) Huang Jian-ming (China Institute of Metrology)

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 ECG display section (2) 5.2 Heart rate display section (2) 6 General Requirements (2) 6.1 appearance and work of (2) 6.2 Functional requirements (3) 6.3 Climate requirements (3) 6.4 Mechanical environmental requirements (3) 6.5 Power adaptability (3) 6.6 EMC requirements (3) 7 type evaluation item list (3) 8 type evaluation test methods and conditions (4) 8.1 Legal Requirements management inspection (4) 8.2 metrological performance test (4) 8.3 General technical requirements for test (8) Type 9 Judgment principle results (20) Appendix A ECG pattern evaluation original records (21)

Introduction

This outline is intended to provide the technical basis for a complete ECG pattern evaluation. This outline is based JJF 1015- 2002 "Measuring Instruments type evaluation and type approval of universal norms" and JJF 1016-2009 "Measuring Instruments type evaluation Outline guidelines for the preparation, "written and major references, and reference the following documents. JJG760-2003 ECG 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 This outline is the first release. ECG pattern evaluation outline

1 Scope

This type of evaluation framework applicable to ECG (including multi-parameter monitor ECG monitoring section and cardiac defibrillators Care instrument ECG monitoring section) of the type evaluation. 2. References This outline references the following documents. JJG760-2003 ECG 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. For undated references, the latest edition (including all Amendments) apply to this outline.

3 Overview

ECG (hereinafter referred to as the monitor) is a human ECG, heart rate monitoring and dynamic measuring instrumentation. According to the structure and function can be divided into the following four types. ECG display type, display type ECG heart rate, electrocardiogram Type display records, display ECG heart rate and ECG recording type.

4 legal management requirements

4.1 units of measurement requirements Measuring instruments shall be the legal units of measurement. 4.2 With regard to legal metrology marking and identification requirements for measuring instruments Measuring instruments must nameplate or panel, table top clear part of legal metrology marking and labeling standard measuring instruments Knowledge, its marks, logos and instructions must be clear, solid and reliable. 4.2.1 legal metrology signs generally include the following --- Measurement equipment manufacturing license logo and number (test prototype should stay out of the corresponding position); --- Measurement equipment type approval mark and number (test prototype may be left out of the corresponding position; this item is not mandatory Provisions); --- Product quality stamps certificate (this can be provided separately from the body and measuring instruments).

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