GB 9706.225-2021 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 an article explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or article will indicate this. If this is not the case, the relevant chapter or article applies 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 ECG machines that provide ECG reports for diagnosis, as defined in 201.3.63, hereinafter referred to as ME devices.
This document does not apply to the following cases:
a) Parts of ME devices that provide ECG vector loops;
b) Dynamic ECG ME devices not used to obtain diagnostic ECG reports, covered by YY 9706.247;
c) ECG monitors not used to obtain diagnostic ECG reports, covered by GB 9706.227.
Note 1: ME devices include:
a) Direct-tracing ECG machines;
b) Other ME devices that provide ECG reports for diagnosis, such as patient monitors, defibrillators, and exercise test devices;
c) ECG machines that can still display ECG data away from the patient (for example, via telephone lines, networks, or storage media). These ME devices or ME systems, except for the transmission media, are within the scope of this document.
Note 2: ME devices that provide diagnostic and monitoring function options must meet the requirements of their corresponding standards when configuring these functions.
ME devices intended for use in extreme environmental conditions or uncontrolled environments (for example, ambulances, air tr