EN 60601-2-10

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Logo of the German Institute for Standardization DIN EN 60601-2-10
Area Medical technology
title Medical electrical equipment - Part 2-10: Particular requirements for the safety of equipment for stimulating nerves and muscles
Latest edition 4.2003
ISO IEC 60601-2-10: 1987 + A1: 2001-09 + Corrigendum 1: 2002

The EN 60601-2-10 with the title "Medical electrical devices - Part 2-10: Special requirements for the safety of devices for the stimulation of nerves and muscles" is part of the EN 60601 series of standards .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-10 .

The standard is based on the international version IEC 60601-2-10. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-10 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines for devices for stimulating nerves and muscles.

validity

The German edition 4.2003 has been accepted as a German standard from 11.2004 .

  • The current version (4.2003) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • The 6.2005 edition is to be used in accordance with the 2nd edition of DIN EN 60601-1.
  • There is a draft standard DIN IEC 60601-2-10: 2009-12, which is intended for the 3rd edition of DIN EN 60601-1.

scope of application

The special stipulations contain requirements for the safety of devices for the stimulation of nerves and muscles for use in physical medicine, hereinafter referred to as devices or electrical stimulation devices.

The following devices are excluded:

  • Devices for implantation or for connection to implanted electrodes
  • Devices specifically designed to stimulate the brain (such as electroconvulsive devices)
  • Devices for neurological research
  • Cardiac pacemaker (partially covered in EN 60601-2-31 )
  • Devices to be worn on the body
  • Stimulation current devices that are built in for use during operations
  • Devices intended for diagnosis using the evoked potentials method (dealt with in EN 60601-2-40 )
  • Devices intended for electromyography (dealt with in EN 60601-2-40)
  • Devices for defibrillation of the heart
  • Devices designed solely for the transcutaneous stimulation of nerves and muscles for pain relief.

extra information

The following changed requirements are contained in EN 60601-2-10 (extract):

  • Protection against dangerous output values