YY/T 1635-2018Multi-channels electrophysiology recording system (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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.

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 document. 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.

4 Requirements