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YY 1139-2013: Diagnostic electrocardiographic devices
Status: Obsolete YY 1139: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 1139-2013 | English | 1839 |
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Diagnostic electrocardiographic devices
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YY 1139-2013
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| YY 1139-2000 | English | 719 |
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Single and multichannel electrocardiograph
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YY 1139-2000
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PDF similar to YY 1139-2013
Basic data | Standard ID | YY 1139-2013 (YY1139-2013) | | Description (Translated English) | Diagnostic electrocardiographic devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 46,418 | | Older Standard (superseded by this standard) | YY 1139-2000 | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies performance requirements for diagnostic ECG device, the device has a direct recording device. All parts of ECG diagnostic equipment applicable to this standard, they should be included to obtain from the body surface ECG, amplifies | YY 1139-2013: Diagnostic electrocardiographic devices---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.
Diagnostic electrocardiographic devices
ICS 11.040.50
C39
People's Republic of China pharmaceutical industry standards
Replacing YY 1139-2000
ECG diagnostic equipment
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Definitions 2
4 Requirements 5
5 Test methods 15
Appendix A (informative) introduced the basic reason of this standard 29
1 triangular wave signal (4.2.7.2, Method D) 11
Figure 2 illustrates the time and amplitude measurements 16
3 Common test circuit 17
4 internal noise, common mode rejection test circuit 23
Figure 5 Defibrillation overload test circuit test [5.9.14.2.2] 26
6 Pacing overload test circuit 27
Figure A.1 defibrillator discharge equivalent circuit 41
Table 1 patient electrode connection definition and color code 6
Table 2 Label/summary statement of claim 7
Table 3 leads Definition 8
Table 4 Frequency response 10
13 Table 5 Summary of Performance Requirements
Table 6 Test ECG patient electrode connection combinations 18
Table 7 standard lead set of weighting factors in patients with a combination of electrode connection and tolerances 21
Table 8 Frank vector weighting factor test 21
Table 9 leads portfolios and defibrillation discharge test 27 times
Table 10 is used to display pacemaker pulse test patient electrode connection 28
Table A.1 patient electrode connection definition and color code 31
Table A.2 typical crowd of single-electrode impedance limit expectations 38
Foreword
This special standard for medical electrical equipment performance standards.
This dedicated drafting standards in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 1139-2000 "single-channel and multi-channel ECG machine", and YY 1139-2000 main technical differences are as follows.
--- Remove the sensitivity and output impedance require an external output, replace manual should indicate the correct external device is connected;
--- Remove the sensitivity and input impedance requires an external DC input signal;
--- Remove the print resolution requirements;
--- Adjust the frequency characteristics of the requirements;
--- Adjust the noise level requirements;
--- Increasing the time and amplitude scale requirements;
--- To increase the release of energy loss in patients with the requirements;
--- Increased requirements pacing pulse display capabilities.
Since the implementation of this standard, YY 1139-2000 "single-channel and multi-channel ECG machine" abolished.
The standard reference to American National Standard ANSI/AAMIEC 11.1991/(R) 2001/(R) 2007 "ECG diagnostic equipment."
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee (TC10/SC5) proposed.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee (TC10/SC5) centralized.
This standard was drafted. Shanghai Medical Device detection, Shenzhen City rationale State precision Instruments Incorporated.
The main drafters of this standard. Yu and Tao Kan, Qiu everywhere.
This standard replaces the standards previously issued as follows.
--- YY 91139-1999;
--- YY 1139-2000.
ECG diagnostic equipment
1 Scope
This standard ECG diagnostic equipment (hereinafter referred to, or devices) 3.9 definition establishes the minimum performance requirements, the device has credited directly
It means recorded. All parts of ECG diagnostic equipment applicable to this standard, they should include ECG obtained from the body surface, amplifies the signal
And adapted to a diagnosis of cardiac electrical activity displayed the signal. This standard ECG electrodes diagnostic equipment from the input to the output is displayed Regulation
Set requirements.
NOTE. In the performance criterion specified in this standard is mainly used to verify the manufacturer's design or evaluation.
Chapter 5 of the ruling purpose test method is to provide some means to explicitly establish compliance with this standard. These test methods are not used
To verify the performance of a single device, whether it is used to check the quality of a manufacturer's warranty or routine inspections within the hospital. In addition, according to the ruling again
Defined test method allows the use of other design verification method, as long as those methods equivalent to those ruled to have test methods comparable test
Test results.
1.1 For
Apply to this standard includes the following equipment.
a) direct recording ECG;
b) used in other medical devices (eg. patient monitors, defibrillators, stress testing equipment) in the ECG machine, as long as these devices with
ECG diagnostic functions;
c) the patient ECG signal display functions remotely, through their cable, telephone, telemetry or storage medium, as long as these devices have heart
FIG electrical diagnostic functions. These devices comply with the entire output of the system - the relationship between the input functions of performance requirements.
1.2 Not applicable equipment
Within the scope of this standard does not include the equipment.
a) Equipment ECG data collected from the outer surface of the non-human;
b) equipment for the Interpretation and pattern recognition (for example, QRS detection, alarm circuit, heart rate meter, diagnostic algorithms);
c) fetal electrocardiogram monitor;
d) Holter monitoring equipment, including ECG recorders and auxiliary scanning and reading device;
e) diagnostic ECG devices nonpermanent display;
f) vector ECG machine, it is a cycle;
g) ECG device, expected to be used in extreme or uncontrolled environmental conditions of the device in a hospital or clinic outside;
h) with or without a heart rate meter and the alarm of ECG, the monitor is mainly used to detect heart rhythm (ECG monitoring equipment from these
Instrument care covered by the standard).
Note. If the device has both diagnostic functions with monitoring function, the function should be selected must meet the relevant requirements of the standard. meet the diagnostic function ECG diagnostic equipment
The standards, to meet the monitoring function of ECG standards.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
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