GB 9706.204-2022
Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (English Version)

Standard No.

GB 9706.204-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 9706.204-2022

Replace

GB 9706.8-2009

Scope

The requirements specified in this document are for commonly used defibrillators with or without an integrated monitor, that is, an ME EQUIPMENT containing a capacitor as an energy storage device. This capacitor is charged to a high voltage and connected to the output electrode either directly or through a series inductor or resistor. In the first edition of this document, a distinction was made between defibrillators and defibrillators-monitors. This is due to the parallel development of the latter and the draft specification for the defibrillator, whose specifications were merged in a later draft. In this edition, such a distinction is no longer necessary and has been removed. This document does not propose requirements for implantable defibrillators, because there are too many differences in consideration, so they are treated differently. Since the publication of the first edition of this document, automated external defibrillators (AEDs) have become widely available. In order to standardize these devices, several new requirements have been revised or proposed in this document. Various therapeutic waveforms are applied to remove cardiac fibrillation, it includes sinusoidal decay wave, bi-directional wave and exponential truncated wave. This should be given further consideration by defibrillator designers, responsible parties and evaluators. Clinical studies have demonstrated that fibrillation removal efficacy varies greatly with waveform shape, as are other parameters, including: voltage amplitude, delivered energy, slope, and total duration. Waveform technology is advancing rapidly. These are not included in the specific security requirements of this document. However, due to the sensitivity of efficacy to changes in these parameters, appropriate clinical validation should be considered necessary. Particular attention should be given to confirming the efficacy of waveforms with insufficient current or prolonged duration, and to confirming the safety of waveforms with excessive peak currents. Clause 201.4.2.1.5 Collateral Standard 1.3 Particular Standard 2 Terms and Definitions 201.

GB 9706.204-2022 Referenced Document

• GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement

GB 9706.204-2022 history

• 2022 GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• 2009 GB 9706.8-2009 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators
• 1995 GB 9706.8-1995 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators has been changed from GB 9706.8-2009 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators.

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