标准摘要
[中文适用范围]: 本部分 IEC 60601 规定了手术台的安全要求,无论是否具有电气部件,包括用于将手术台顶部运输到或从手术台底座或基座分离的手术台顶部运输器。 注:另见 IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012 和 IEC 60601-1:2005/AMD2:2020 的 4.2。 本特定标准不适用于: - 牙科患者椅(见 ISO 7494-1) - 检查椅和沙发 - 诊断、介入和治疗设备的患者支撑系统(见 IEC 60601-2-54 或 IEC 60601-2-43) - 手术台加热毯(见 IEC 80601-2-35 或 IEC 60601-2-35) - 患者转运设备 - 分娩台和分娩床 - 医疗床(见 IEC 60601-2-52 和 EN 50637) - 野战台 如果手术台与诊断和/或治疗设备组合使用,则相关特定标准的要求也适用。 [外文原描述]: IEC 60601-2-46:2023 CMV contains both the official standard and its commented version. The commented version provides you with a quick and easy way to compare all the changes between IEC 60601-2-46:2023 edition 4.0 and the previous IEC 60601-2-46:2016 edition 3.0. Furthermore, comments from IEC SC 62D experts are provided to explain the reasons of the most relevant changes, or to clarify any part of the content. IEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This particular standard does not apply to - dental patient chairs (see ISO 7494-1), - examination chairs and couches, - patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43), - operating table heating blankets (see IEC 60601-2-35), - patient transfer equipment, - delivery tables and delivery beds, - medical beds (see IEC 60601-2-52 and EN 50637), and - field tables. IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
英文名称Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables