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JJF 1149-2014: Calibration Specification for Cardiac Defibrillators
Status: Valid JJF 1149: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JJF 1149-2014 | English | 759 |
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Calibration Specification for Cardiac Defibrillators
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JJF 1149-2014
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| JJF 1149-2006 | English | 759 |
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Calibration Specification for Cardiac Defibrillators and Cardiac Defibrillators-monitors
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JJF 1149-2006
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PDF similar to 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| Word Count Estimation | 33,334 | | Date of Issue | 8/1/2014 | | Date of Implementation | 2/1/2015 | | Older Standard (superseded by this standard) | JJF 1149-2006 | | Quoted Standard | JJG 760-2003; GB 9706.8-2009 | | Adopted Standard | IEC 60601-2-14-2010, NEQ | | Regulation (derived from) | AQSIQ Notice 2014 No. 89 | | Issuing agency(ies) | General 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---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.
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 to editorial changes, the main technical specification of the changes are as follows.
--- Standardized name changed from "cardiac defibrillators and cardiac defibrillator monitor calibration standard" to "cardiac defibrillator
Calibration specification ";
--- Adds automatic external defibrillators, metrological characteristics and requirements of the appropriate calibration method;
--- Increased transcutaneous pacemaker defibrillator function metrological characteristics requirements and the corresponding calibration methods;
--- Remove the metrological characteristics requirements for the energy loss rate and the corresponding calibration method, and by releasing the energy discharge
Defining moment to ensure that the defibrillator after being charged to start automatic internal discharge time of the release of a former energy
Meet the requirements;
--- Remove the charge and discharge times, the discharge inside the technical requirements and the corresponding calibration method;
--- Charging time, synchronous mode and the ECG monitor after defibrillation recovery and other technical requirements from the metrological characteristics carve
Leave out, and the inclusion of the relevant requirements of appearance, check the project work.
The specification previously issued as follows.
--- JJF 1149-2006.
Defibrillator calibration specification
1 Scope
This specification applies directly related to a manual defibrillator cardiac defibrillators and automated external defibrillator (AED)
Calibration metrological characteristics; does not apply to implantable defibrillators, remote defibrillator calibration.
2. References
This specification refers to the following documents.
JJG760-2003 ECG
GB 9706.8-2009 Medical electrical equipment - Part 2-4. Particular requirements for the safety of cardiac defibrillators
For dated references, only the dated edition applies to this specification; undated reference documents
Member, the latest edition (including any amendments) applies to this specification.
3 terminology and units of measurement
3.1 Terms
GB 9706.8-2009 defined and the following terms and definitions apply to this specification.
3.1.1 Defibrillator cardiacdefibrilators [GB 9706.8-2009,2.1.101]
Electric pulses applied through the electrode to the skin (electrode body) or in patients exposed heart (electrode body), with
Defibrillation to the heart of medical electrical equipment. You can call or defibrillator device.
Note. Currently, cardiac defibrillators main product forms. stand-alone manual defibrillator (unintentional power-on monitor), manual defibrillation guardianship
Instrument, AED Without ECG monitor, AED with ECG monitor, manual/semi-automatic defibrillator monitor (integrated manual defibrillation,
Automated external defibrillator) and the like.
3.1.2 Manual defibrillator manualdefibrilators [GB 9706.8-2009,2.12.109]
Energy can be selected manually by the operator, the charging and discharging of the defibrillator.
3.1.3 Automated External Defibrillator automatedexternaldefibrilators, AED [GB 9706.8-2009,
2.1.109] ①
① This entry terms marked with changes, unlike GB 9706.8-20092.1.109.
Once activated by the operator, by analysis of body surface electrodes placed on the chest ECG obtained (Electrocardio-
graph, ECG), identify shockable heart rhythm, when it detects a shockable heart rhythm self-operated defibrillator.
NOTE. AED provides different automatic control level, according to their charge and the degree of human intervention discharge operation may be three cases.
After a) AED detected will reach a "shock" decision when a shockable rhythm, subject to confirmation by the operator, before doing electric shock
Ready to work;
After b) AED reached a "shock" decision, automatically charging the defibrillator discharge behavior but requires manual intervention;
c) AED reached a "shock" after the judgment, can automatically complete charge and discharge of the patient, this is often referred to as fully automatic AED
Move AED, it can be used for public defibrillation.
3.1.4 defibrillator monitor cardiacdefibrilators-monitor
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