NA 022

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Project

Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten

Abstract

Below are the main changes being introduced by the attached draft amendment: - Providing clarification for the definitions of how to determine the appropriate settings for measurements. - Reintroducing the specification to clearly indicate whether the product features applied parts. - Eliminating the test inspired by the IP test due to confusion and its inadequacy for qualifying a product for an IP rating. - Enhancing the guidelines on what should be included in user manuals, including the requirement to provide values with corresponding tolerances to ensure a more accurate representation of the displayed data. - Removing the paragraph on product cleaning, as it is impractical to require manufacturers to be aware of the legislation in every country worldwide.

Begin

2026-08-21

Planned document number

DIN EN IEC 60601-2-41/A1

Project number

02234130

Responsible national committee

DKE/K 805 - Apparate zur therapeutischen Unterstützung  

Contact

Sascha Man-Son Lee

Merianstr. 28
63069 Offenbach am Main

Tel.: +49 69 6308-291

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