GB 9706.8-2009 Replaced National standards force_standard

GB 9706.8-2009 Medical electrical equipment—Part 2-4:Particular requirements for the safety of cardiac defibrillators

Publish Date: 2009-05-06 Implement Date: 2010-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 9706.8-2009

Standard Type: National standards

Standard Status: Replaced

is_force_gb: yes

CCS Name: Medical electronic instruments and equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2009-05-06

Implement Date: 2010-03-01

Pages: 40 pages

Scope

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.