2. Getting involved
3. Standards Committees
4. DKE

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

Overview

This standard specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. Excluded are devices intended for implantation or for connection to implanted electrodes; medical electrical devices intended for brain stimulation (for example, medical electrical devices for electroconvulsive therapy); medical electrical equipment intended for neurological research; external pacemakers (see IEC 60601-2-31); medical electrical equipment intended for diagnosis using the evoked potential method (IEC 60601-2-40); medical electrical equipment intended for electromyography (IEC 60601-240); and medical electrical equipment for cardiac defibrillation (see IEC 60601-2-4). The standard differs from DIN EN 60601-2-10 (VDE 0750-2-10)2017-09 as follows: a) the reference to the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020 has been updated; b) normative references have been revised; c) Clause "Patient-coupled leads" has been revised and a note with regard to the phantom added. This standard specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine.

Document: references other documents

Responsible national committee

DKE/UK 804.6 - Therapie, Chirurgie