IEC 60601-2-46:2023 医用电气设备.第2-46部分:手术台基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-46:2023

中文名称：医用电气设备.第2-46部分:手术台基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

发布日期：2023-05-26

标准范围

IEC 60601-2-46:2023规定了手术台的安全要求，无论是否具有用于将手术台顶部运输到或从具有可拆卸手术台顶部的手术台的底座或基座运输的电气部件，包括运输器。本特定标准不适用于-牙科病人椅(参见ISO 7494-1)，-检查椅和检查床，-诊断、介入和治疗设备的患者支持系统（参见IEC 60601-2-54或IEC 60601-2-43），-手术台加热毯（参见IEC 60601-2-35），-患者转移设备，-分娩台和分娩床，-医用床（参见IEC 60601-2-52和EN 50637），以及-字段表。IEC 60601-2-46:2023取消并取代2016年发布的第三版。本版构成技术修订版。与上一版本相比，本版本包括以下重大技术变更:结构符合IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020。

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.

标准预览图