2. Getting involved
3. Standards Committees
4. DKE

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

Overview

These particular requirements set out safety requirements for infant phototherapy equipment, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device. The purpose of these particular requirements is to establish specific requirements for the basic safety and essential performance characteristics of infant phototherapy equipment, to reduce hazards to patients and operators as much as possible, and to specify tests that can be used to verify compliance with the requirements. This document does not apply to: This document does not apply to: - devices supplying heat via blankets, pads or mattresses in medical use; for information, see IEC 60601-2-35; - infant incubators; for information, see IEC 60601-2-19; - infant transport incubators, for information see IEC 60601-2-20; - infant radiant warmers, for information see IEC 60601-2-21. The standard differs from DIN EN IEC 60601-2-50 (VDE 0750-2-50): 2022-08 as follows: a) the clause "Normative references" has been revised and supplemented; b) individual terms and definitions have been revised and the reference to IEC 60601-1:2005/AMD2:2020 added; c) Table 201.101 updated; d) in the clause "Electromagnetic disturbances - Requirements and tests", the reference to IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 has been added; e) Annex AA has been revised and supplemented. These particular requirements set out requirements for the safety of infant phototherapy equipment.

Document: references other documents

Responsible national committee

DKE/UK 812.7 - Medizinische Geräte in der Pädiatrie