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naSRPS EN IEC 60601-2-46:2022

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

General information

40.60     May 24, 2022

ISS

N062

European Norm

11.140  

English  

Scope

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.

Related directives

Directives related to this standard.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN IEC 60601-2-46:2019

NOW

PROJECT
naSRPS EN IEC 60601-2-46:2022
40.60 Close of voting
May 24, 2022

Related project

Adopted from prEN IEC 60601-2-46:2022

Adopted from IEC 60601-2-46:2023 ED4