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YY/T 1841-2022Cardiac electrophysiology mapping system (English PDF)

心脏电生理标测系统

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2023

Scope

YY/T 1841-2022 is the English-translated version of 心脏电生理标测系统.

YY/T 1841-2022 is the Chinese pharmaceutical industry standard for the cardiac electrophysiology mapping system, the equipment that records intracardiac signals and builds the map on which an arrhythmia is located and ablated.

It sets the requirements and the test methods, covering the amplifier channels and their noise, gain and frequency response, the sampling and display of the intracardiac and surface signals, the accuracy with which the catheter position and the activation times are determined, the stimulator where present, and safety and electromagnetic compatibility by reference to the general standards. Issued on 18 May 2022, it has applied since 1 June 2023.

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Document preview — YY/T 1841-2022

National Standard of the People's Republic of China

Classification: C 39

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirements
4.1 Working conditions
4.1.1 Test conditions
4.1.2 Test device
4.1.3 Test circuit
4.2 ECG
4.3 Positioning performance
4.3.1 Positioning range
4.3.2 Positioning accuracy
4.3.3 Positioning stability
4.3.4 Positioning Repeatability Accuracy
4.3.5 Positioning angle accuracy
4.4 Pressure performance
4.4.1 Pressure accuracy
4.4.2 Pressure range
4.5 System software functions
4.6 Environmental test requirements
5 Test method
5.1 Working conditions
5.1.1 Test conditions
5.1.2 Test device
5.1.3 Test circuit
5.2 ECG
5.2.1 Surface ECG
5.2.2 Intracardiogram
5.3 Positioning performance
5.3.1 Positioning range
5.3.2 Positioning accuracy
5.3.3 Positioning stability
5.3.4 Positioning Repeatability Accuracy
5.3.5 Positioning angle accuracy
5.4 Pressure performance
5.5 System software functions
5.6 Environmental test requirements
Appendix A (Informative) Positioning Performance Test Method

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

1 Scope

This document specifies the requirements and test methods for the cardiac electrophysiological mapping system (hereinafter referred to as the system).

This document applies to cardiac electrophysiological mapping systems.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance

GB 9706.225-2021 Medical Electrical Equipment Part 2-25.Special Requirements for Basic Safety and Basic Performance of Electrocardiographs

GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 A system that uses the information obtained by magnetic field, electric field or magnetoelectric hybrid positioning to build a three-dimensional heart model, and converts the collected ECG

The number is integrated on the model of the anatomical site.

3.2 Locationrange

The cardiac electrophysiological mapping system satisfies the space of positioning accuracy.

3.3 Location accuracy

In the three-dimensional positioning range, the difference between the actual position of the catheter and the displayed position of the system.

3.4 Location stability

The difference between the measured position of the catheter and the actual position is the change value generated by the prolongation of the working time of the cardiac electrophysiological mapping system.

3.5 Positioning repeatability

The difference between the catheter moving to another position within the positioning range and returning to the expected position after a period of time.

3.6 Orientationaccuracy

The system displays the difference between the orientation of the catheter and the actual orientation within the positioning accuracy.

3.7 Pressure range contactforcerange

The pressure range that the catheter can measure.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

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