YY 9706.256-2023 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.
Replacement:
This document specifies the dedicated requirements for the basic safety and basic performance of clinical thermometers and their accessories (hereinafter referred to as ME devices). This document applies to all electronic clinical thermometers used to measure patient temperature, including medical electrical equipment for measuring and displaying body temperature.
Example 1: ME devices that use accessories (e.g., pulmonary artery catheters) to determine cardiac output by heat dilution, if they display body temperature, are included within the scope of this document.
Example 2: ME devices that use accessories (e.g., Foley catheters with body temperature probes) are within the scope of this document.
Clinical thermometers can be equipped with interfaces to include secondary indicators, printing devices, and other auxiliary equipment, thereby forming medical electrical systems. This document does not apply to auxiliary equipment. It also does not apply to screen thermographs used for non-invasive fever temperature screening of the general population in indoor environments (see IEC 80601-2-59 [4]).
The inherent hazards of the intended physiological functions of ME devices or ME