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JJF 1149-2014

JJF 1149-2014_English: PDF (JJF1149-2014)
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JJF 1149-2014English759 Add to Cart 6 days Calibration Specification for Cardiac Defibrillators JJF 1149-2014 Valid JJF 1149-2014

BASIC DATA
Standard ID JJF 1149-2014 (JJF1149-2014)
Description (Translated English) Calibration Specification for Cardiac Defibrillators
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Classification of International Standard 17.220
Word Count Estimation 33,387
Date of Issue 2014/8/1
Date of Implementation 2015/2/1
Older Standard (superseded by this standard) JJF 1149-2006
Quoted Standard JJG 760-2003; GB 9706.8-2009
Adopted Standard IEC 60601-2-14-2010, NEQ
Drafting Organization General Logistics Department of the Ministry of Health Drug and Instrument Control; China Institute of Metrology; Test Center measured the army medical; Hangzhou quality technical supervision detection hospital; Shenzhen Mindray Bio-Medical Electronics Co
Administrative Organization National Radio Measurement Technology Committee
Regulation (derived from) AQSIQ Notice 2014 No. 89
Issuing agency(ies) State Administration of Quality Supervision, Inspection and Quarantine
Summary This Standard applies to manual defibrillators and automated external defibrillators (AED) defibrillator calibration is directly related to the metrological characteristics; does not apply to implantable defibrillators, remote defibrillator calibration.

JJF 1149-2014
Calibration Specification for Cardiac Defibrillators
People's Republic of China National Metrology Technical Specifications
Defibrillator calibration specification
Issued on. 2014-08-01
2015-02-01 implementation
The State Administration of Quality Supervision, Inspection and Quarantine released
Defibrillator calibration specification
Replacing JJF 1149-2006
Focal point. the National Radio Technical Commission metering
The main drafting units. General Logistics Department of Health Drug and Instrument Control
China Institute of Metrology
Participated in the drafting unit. Measurement Army Medical Research Test Center
Hangzhou quality technical supervision detection hospital
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
This specification commissioned the National Radio Technical Commission responsible for the interpretation of measurement
The main drafters of this specification.
Xue Li Yong (General Logistics Department of the Ministry of Health Drug and Instrument Control)
Jia Jiange (General Logistics Department of the Ministry of Health Drug and Instrument Control)
Huang Jian-ming (China Institute of Metrology)
Drafters participate.
Wu Wenjun (General Logistics Department of the Ministry of Health Drug and Instrument Control)
Yang Dong (Army Medical Research Test Center measured)
Jiang Xueping (Hangzhou Quality and Technical Supervision and Inspection Institute)
Li Yong (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.)
table of Contents
Introduction (Ⅲ)
1 Scope (1)
2. References (1)
3 terminology and units of measurement (1)
3.1 The term (1)
3.2 units of measurement (2)
4 Overview (2)
5 Metrological characteristics (2)
5.1 releases energy (2)
5.2 charging or discharging process inside the center electrode monitor tracings signal amplitude fluctuations (2)
5.3 transcutaneous pacing pulse frequency (3)
5.4 transcutaneous pacing pulse width (3)
5.5 transcutaneous pacing pulse current amplitude (3)
5.6 ECG voltage indication error (3)
5.7 ECG display shows the scanning speed error (3)
5.8 frequency characteristics (3)
5.9 heart rate indication error (3)
6 calibration conditions (3)
Environmental conditions 6.1 (3)
6.2 standards and other measuring equipment (3)
7 calibration items and calibration methods (4)
7.1 Appearance working properly check (4)
7.2 releases energy (6)
7.3 charging or electrical fluctuations center monitor signal amplitude tracings of an internal discharge process (8)
7.4 transcutaneous pacing pulse frequency (9)
7.5 transcutaneous pacing pulse width (10)
7.6 transcutaneous pacing pulse current amplitude (10)
7.7 ECG voltage indication error (11)
7.8 ECG display shows the scanning speed error (11)
7.9 Frequency Characteristics (11)
Heart rate indication error 7.10 (11)
8 calibration results expression (11)
8.1 Calibration records (11)
8.2 Calibration process results (11)
9 Recalibration interval (12)
Appendix A sync pattern detector (13)
Appendix B Measurement Uncertainty Example (16)
Appendix C calibration record format (20)
Appendix D calibration certificate page format (24)
introduction
JJF 1071 "National Calibration Specifications writing rules", JJF 1001 "common measurement terms and definitions"
JJF 1059 "Evaluation and Expression of Uncertainty in Measurement" series together constitute the basic norms of the present specification revision.
The main technical specification calibration based on GB 9706.8-2009 "Medical electrical equipment - Part 2-4. Heart
Dirty defibrillator requirements for safety "and IEC 60601-2-42010-12" Medical electrical equipment - Part 2-4. Heart
Defibrillator safety and performance requirements for the main "Medicalelectricalequipment-Part 2-4. Particularre-
quirementsforthebasicsafetyandessentialperformanceofcardiacdefibrilators. heart
Metrological characteristics and calibration defibrillator ECG functions not directly related to defibrillation can refer JJG760-2003
"ECG" Terms and Conditions.
Compared with JJF 1149-2006, in addition