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YY/T 1635-2018

Chinese Standard: 'YY/T 1635-2018'
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YY/T 1635-2018English469 Add to Cart Days<=5 Multi-channels electrophysiology recording system Valid YY/T 1635-2018
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Detail Information of YY/T 1635-2018; YY/T1635-2018
Description (Translated English): Multi-channels electrophysiology recording system
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C39
Classification of International Standard: 11.040.50
Word Count Estimation: 26,230
Date of Issue: 2018-12-20
Date of Implementation: 2020-01-01
Drafting Organization: Shanghai Medical Device Testing Institute, Sichuan Jinjiang Electronic Technology Co., Ltd.
Administrative Organization: National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC 10/SC 5)
Regulation (derived from): State Drug Administration Announcement No. 97 of 2018
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration


YY/T 1635-2018
(Multi-channel physiological recorder)
ICS 11.040.50
C39
People's Republic of China Pharmaceutical Industry Standard
Multi-channel physiological recorder
Multi-channelselectrophysiologyrecordingsystem
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
3.1 Multi-channel physiological recorder 1
4 Requirements 1
4.1 Working conditions 1
4.2 Equipment Requirements 2
4.3 Security requirements 6
4.4 Electromagnetic compatibility requirements 6
4.5 Environmental Test Requirements 7
5 Test method 7
5.1 General Test Requirements 7
5.2 Test conditions 8
5.3 Test device 8
5.4 Test circuit 8
5.5 Test signal and output measurement 8
5.6 Noise interference 8
5.7 Recording conditions 8
5.8 Requirements 9
Appendix A (informative) 19
A.1 Introduction 19
A.2 The reasons for the various clauses in the standard 19
Figure 1 General Test Circuit 9
Figure 2 Internal noise, common mode rejection test circuit 13
Figure 3 Protection test for defibrillation effect 15
Figure 4 Test circuit 15 of the defibrillation overload test
Figure 5 Dynamic test of limiting electrical energy from different components 16
Figure 6 pacing overload test circuit 17
Table 1 Frequency response 3
Table 2 Environmental test conditions and test items 7
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is determined by the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This standard was drafted. Shanghai Medical Device Testing Institute, Sichuan Jinjiang Electronic Technology Co., Ltd.
The main drafters of this standard. Gu Zhengyu, Zhang Xiaohua, Xue Fen.
introduction
The technical indicators of this standard body surface electrocardiogram refer to the requirements of YY 1139-2013 "Electrocardial Diagnostic Equipment".
The technical indicators of this standard intracardiac electrocardiogram refer to the requirements of YY 1139-2013 "Electrocardial Diagnostic Equipment", due to the surface electrocardiogram and heart
The internal electrocardiogram has different frequency bands and different impedances. The main technical differences between YY 1139 and.2013 are as follows.
--- Revised the requirements of working conditions;
--- Removed the requirements defined by the lead;
--- Revised the input dynamic range;
--- Revised the requirements for gain setting and accuracy;
--- Revised time base selection and accuracy requirements;
--- Revised the requirements for track width and visibility;
--- Revised the requirements for frequency and impulse response;
--- Removed the requirement for the lead weighting factor;
--- Revised the requirements for input impedance;
--- Revised the requirements for common mode suppression;
--- Revised the requirements for system noise;
--- Revised the requirements for channel crosstalk;
--- Revised the requirements for overload protection;
--- Removed the requirement for hazardous currents;
--- Revised the requirements for auxiliary output.
This standard has a blood pressure technical indicators cited YY 0783-2010 "medical electrical equipment section 2-34. invasive blood pressure monitoring
Requirements for special requirements for safety and basic performance, as multi-channel physiological recorders are cardiac electrophysiological surgical equipment, with YY 0783-
The main technical differences in.2010 are as follows.
--- Removed the request for an alarm.
This standard non-invasive blood pressure technical indicators cited YY 0667-2008 "medical electrical equipment part 2-30. automatic circulation non-invasive blood
Special requirements for safety and basic performance of pressure monitoring equipment, YY 0670-2008 "non-invasive automatic measurement of blood pressure monitor" requirements, due to multi-channel students
The logger is a cardiac electrophysiology surgical device, and the main technical differences with YY 0667-2008 are as follows.
--- Removed the request for an alarm.
The technical indicators of this standard blood oxygen monitoring reference YY 0784-2010 "medical electrical equipment medical pulse oximeter equipment basic security
The requirements for full and main performance specific requirements, because multi-channel physiological recorder is a cardiac electrophysiology surgical equipment, and YY 0784-2010 main
The technical differences are as follows.
--- Removed the request for an alarm.
Multi-channel physiological recorder
1 Scope
This standard specifies the requirements and test methods for multiple physiological recorders.
This standard is applicable to multi-channel physiological recorders, and its scope of application is used to collect human body surface electrocardiogram and intracardiac electrocardiographic characteristic signals.
Continuously recorded and/or displayed device that depicts the waveform of each cardiac cycle and the beat changes reflected to determine the heart rhythm;
The device can also have auxiliary functions such as non-invasive blood pressure monitoring, invasive blood pressure monitoring, and pulse oximetry monitoring.
This standard does not apply to ECG monitors.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 10793-2000 Medical electrical equipment - Part 2. Particular requirements for safety of electrocardiograph
GB/T 14710-2009 Environmental requirements and test methods for medical electrical equipment
YY 0505-2012 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standard. Electromagnetic Compatibility Requirements and Test
YY 0667-2008 Medical electrical equipment - Part 2-30. Safety and basic performance of automatic cycle non-invasive blood pressure monitoring equipment
Requirements
YY 0670-2008 Non-invasive automatic measurement sphygmomanometer
YY 0782-2010 Medical electrical equipment - Part 2-51. Safety and basics for recording and analysis of single and multi-channel electrocardiographs
Special requirements
YY 0783-2010 Medical electrical equipment - Part 2-34. Particular requirements for safety and basic performance of invasive blood pressure monitoring equipment
YY 0784-2010 Medical electrical equipment Medical pulse oximeter equipment basic safety and main performance specific requirements
YY 1139-2013 ECG diagnostic equipment
3 Terms and definitions
GB 9706.1-2007, YY 0667-2008, YY 0670-2008, YY 0783-2010, YY 0784-2010, YY 1139-
The following terms and definitions defined in.2013 apply to this document.
3.1
Multi-channelselectrophysiologyrecordingsystem
A device for collecting a human body surface electrocardiogram and an intracardiac electrocardiographic characteristic signal for continuous recording and/or display, which depicts each
The waveform of the cardiac cycle, as well as the beat changes reflected in the determination of the heart rhythm; the device can also have non-invasive blood pressure monitoring, invasive blood pressure monitoring,
Auxiliary functions such as pulse oximetry monitoring.
4 requirements
4.1 Working conditions
It is prescribed by the manufacturer; if it is not specified, it shall comply with the requirements of Chapter 10 of GB 9706.1-2007.
Related standard:   YY/T 1519-2017  YY 1139-2013
   
 
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