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YY/T 1635-2018 English PDF

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YY/T 1635-2018: Multi-channels electrophysiology recording system
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PDF similar to YY/T 1635-2018


Standard similar to YY/T 1635-2018

YY/T 1933   YY/T 1712   YY/T 1519   YY 9706.231   

Basic data

Standard ID 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 26,297
Date of Issue 2018-12-20
Date of Implementation 2020-01-01
Regulation (derived from) State Drug Administration Announcement No. 97 of 2018
Issuing agency(ies) State Drug Administration

YY/T 1635-2018: Multi-channels electrophysiology recording system

---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.
(Multi-channel physiological recorder) ICS 11.040.50 C39 People's Republic of China Pharmaceutical Industry Standard Multi-channel physiological recorder Published on.2018-12-20 2020-01-01 implementation State Drug Administration issued

Content

Foreword III Introduction IV 1 Scope 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.

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