YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables
YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables
Basic Information
Scope
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 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.
Replacement:
This document specifies the safety requirements for operating tables. Whether or not such operating tables have electrical components, including drive mechanisms. Such drive mechanisms are used for the movement of the tabletop of operating tables with detachable tabletops relative to the base (or pedestal) of the operating table.
Note: See 4.2 of the general standard.
This document does not apply to:
——Patient dental chairs;
——Examination chairs and sofas;
——Patient support systems for diagnostic and treatment equipment (see GB 9706.243);
——Heating blankets for operating tables (see YY 9706.235);
——Patient transfer equipment;
——Transfer tables and beds;
——Medical beds (see YY 9706.252);
——Field operating tables.
If the operating table will be used in combination with diagnostic/treatment equipment, the relevant dedicated standards for diagnostic and/or treatment equipment apply.