GB 9706.8-2009
GB 9706.8-2009 Medical electrical equipment—Part 2-4:Particular requirements for the safety of cardiac defibrillators
Abstract
This dedicated standard specifies the safety requirements for cardiac defibrillators defined in 2.1.101. In this article, cardiac defibrillators are referred to as devices from here onwards.
This dedicated standard does not apply to implantable defibrillators, remote-controlled defibrillators, external percutaneous pacemakers, or standalone cardiac monitors (in accordance with GB 9706.25). Cardiac monitors that use separate ECG monitoring electrodes are not within the scope of this standard, unless they are used as the sole reference for rhythm recognition detection in automatic external defibrillators (AEDs) or for synchronized cardioversion detection in ECG defibrillation.
The defibrillation waveform technology is developing rapidly. Literature studies have demonstrated the effectiveness of different waveforms. The scope of this standard deliberately excludes the selection of special waveforms, which includes waveform shape, release energy, efficacy, and safety.
However, due to the critical importance of treatment waveforms, additional annotations have been added to the principle explanation to explain how to consider the selection of waveforms.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Replaced |
| Standard Code | GB 9706.8-2009 |
| CCS | Medical electronic instruments and equipment |
| ICS | Anesthesia, respiration, and resuscitation equipment |
| Implement Date | 2010-03-01 |