This particular standard specifies the safety requirements for cardiac defibrillators as defined in 2.1.101, hereafter referred to as cardiac defibrillators as equipment. This specific standard does not apply to implantable defibrillators, remote defibrillators, external percutaneous pacemakers, and separate heart 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 basis for automatic external defibrillator (AED) rhythm recognition detection or heartbeat detection for synchronized cardioversion.
GB 9706.8-2009 history
2022GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
2009GB 9706.8-2009 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators
1995GB 9706.8-1995 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
GB 9706.8-2009 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators was changed to GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators.