GB 9706.204-2022 Active

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or clause explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or clause will indicate this. If this is not the case, the relevant chapters or clauses apply to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This document specifies the basic safety and basic performance of cardiac defibrillators. This document applies to cardiac defibrillators (hereinafter referred to as ME devices) that are used to restore normal heart rhythm by applying electrical pulses to the patient's skin using external electrodes or to the exposed heart using internal electrodes.
If a chapter or clause explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or clause will indicate this. If this is not the case, the relevant chapters or clauses apply to both ME devices and ME systems.
Except for the general standards of 7.2.13 and 8.4.1, the hazards caused by the intended physiological effects of ME devices or ME systems within the scope of this document are not specifically required in this document.
Note: See the general standards of 4.2.
This document does not apply to implantable defibrillators, remote defibrillators, or standalone cardiac monitors (in accordance with GB 9706.227—2021). Cardiac monitors using independent ECG monitoring electrodes are not within the scope of this document, unless they are used as the sole criterion for AED rhythm recognition detection or synchronized cardio