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Electrocardiographic monitors
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YY 1079-2008
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Basic data | Standard ID | YY 1079-2008 (YY1079-2008) | | Description (Translated English) | Electrocardiographic monitors | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 73,717 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-12-01 | | Older Standard (superseded by this standard) | YY 91079-1999 | | Quoted Standard | GB 9706.1-2007; GB 9706.25-2005; YY 0505-2005 | | Adopted Standard | ANSI/AAMI EC13-2002, NEQ | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the minimum performance requirements of this standard is expected to work under the conditions of use of the method used to obtain the heart rate and ECG waveform monitor. Such monitors all of the following parts shall meet the criteria: a) from the patient's body through non-invasive detection obtained ECG heart rate display, b) amplify and transmit these signals to display heart rate and/or ECG waveform, and c) based on adjustable The alarm limit for continuous heart rate associated with the occurrence of the following phenomena provides alarm: cardiac arrest, bradycardia and/or tachycardia. | YY 1079-2008: 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.
Electrocardiographic monitors
ICS 11.040.50
C39
People's Republic of China pharmaceutical industry standards
Replacing YY 91079-1999
ECG
Posted 2008-04-25
2009-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 Requirements 5
5 Test methods 19
Appendix A (informative) introduced the basic reason of this standard 42
Appendix B (Informative Appendix) CMR Test Design and Application Considerations 58
Annex C (informative) Test pacing pulse forming circuit 65 and description
Table 1 patient electrode connection definition and color code 6
Table 2 Label/10 Summary disclosure requirements
Table 3 Frequency response 14
Table 4 Lead defined 15
16 Table 5 Summary of Performance Requirements
Table 6 combination leads 27
Table 7 is used to display pacemaker pulse test patient electrode connections 31
Table join combinations patient electrode leads 8 standard set of weighting factors and tolerance limits 36
Table 9 Frank vector weighting factor test 37
Table A. 1 typical crowd of single electrode impedance limit expectations 52
1 triangular wave signal (Method B) 14
Experiment 2 T-wave waveform 22 of the suppression
FIG. 3 is used to verify the accuracy of heart rate test waveforms 22
Figure 4 tachycardia test wave 24
Figure 5 Test pacing pulse waveform 26
6 analog test signals ECG QRS complex 26
7 time and amplitude measurements Example 26
8 General test circuit 27
FIG. 9 is used to assess the internal noise and common-mode rejection of the test circuit 33
Figure 10 Pacemaker overload test circuit 39
11 electric surgical test layout 40
Figure 12 electric surgical test circuit 40
Figure B. 1 CMRR test. the mains power supply and buffer 62
Figure B. 2 CMRR test. generator-powered buffer 62
Figure B. 3 extends the ability to offset the common mode rejection ratio test apparatus 63
Figure C. A pacing pulse forming circuit 67
Foreword
This standard is a reference to the American National Standard ANSI/AAMIEC 13.2002 "heart monitors, heart rate meters and alarms" in the performance section
Points prepared ECG monitor performance standards.
This standard YY 91079-1999 major differences are.
--- Increasing the pacemaker pulse rejection capability requirements;
--- Safety requirements according to GB 9706.25-2005 "Medical electrical equipment Part 2. ECG monitoring equipment safety requirements" and
GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" requirements to perform;
--- Increased by YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility
Requirements and testing "electromagnetic compatibility requirements;
From the date of implementation of this standard, YY 91079-1999 repealed.
The Standard Appendix A, Appendix B and Appendix C are informative appendices.
This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. Shanghai Medical Device detection, Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
The main drafters of this standard. and Yu, Guo Hongling.
This standard replaces the standards previously issued as follows.
--- ZBC39004-1988;
--- YY 91079-1999.
ECG
1 Scope
This standard has been waveform monitor heart rate and expected under this standard specified operating conditions using ECG method, indeed
Established the minimum performance requirements. Such monitors all of the following section shall meet this criteria.
a) obtained from the patient's body through non-invasive detection of ECG heart rate display;
b) amplify and transmit these signals to display the heart rate and/or ECG waveform; and
c) adjustable alarm limits based on the following phenomena associated with heart rate continued to provide an alarm occurs. cardiac arrest, bradycardia, and/or
Tachycardia.
Note. The performance requirements specified in this standard mainly to the principles of design specifications for the manufacturer or type of evaluation (assessment type device or a typical
A series of tests must be carried out batch of typical equipment to verify the performance of all design requirements have been met. Manufacturers typically designed for a production
Product models meet all the criteria to obtain a statement of compliance when the formal implementation).
1.1 Standard equipment includes
The following equipment is included in the scope of this standard.
a) is expected in the range of environmental conditions specified in 4.2.1 using a portable ECG monitor and battery-powered ECG monitor;
b) ECG-based operating rooms and intensive care heart rate monitors;
c) the use of telemetry and intensive transfer of ECG;
d) the scope of this standard provides a more complex device basic information described subsystems (such as. Arrhythmia monitor and defibrillator monitor
Instrument); and
e) neonatal/pediatric monitors.
1.2 This standard does not include equipment
The following equipment is not included in the scope of this standard.
a) fetal heart rate monitoring equipment;
b) blood pressure monitoring equipment;
c) pulse rate tracings equipment;
d) the use of invasive cardiac catheter or sensor device to obtain electrical activity displayed;
e) telemetry for emergency ambulance or hospital outside the dynamic monitoring equipment or systems;
f) for subsequent analysis of dynamic data stored ECG monitoring equipment, including scanning and reading device;
g) telephone transmission equipment;
h) expected in hospitals and clinics outside extreme or uncontrollable equipment under ambient conditions for use;
i) diagnostic ECG devices (these devices are included in other standards); and
j) which is similar to monitoring functions and the ability to trigger other instruments for collection, these instruments are not expected to be used as the main treatment for patients
Heart monitor equipment (for example. a spherical inner arterial pumps, ventricular assist devices).
NOTE. Provides monitoring and diagnostic features optional equipment, selected functions shall meet the applicable standards. These standards --- heart monitors, heart rate meter, alarm
Standard or diagnostic ECG equipment standards.
1.3 Differences between monitors
Parts of the standard may not apply to all monitors. These monitors is only required to meet the applicable provisions of this standard.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
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