Medical devices

ETSI is developing a number of standards for medical devices that are implanted in the human body, and communicate to an external device to allow them to be adjusted in situ by qualified medical practitioners.

On a broader theme, ETSI is also involved in creating an eHealth work programme for standards in the Information and Communications Technology (ICT) sector that touch health issues.

Initial ETSI work has concentrated on defining the need for radio spectrum for medical devices, in order to help radio regulators find harmonized frequencies within the European Community.

ETSI has also developed Harmonised Standards for some device types, enabling them to be placed on the European market.

Radio Spectrum - System Reference Documents for several medical applications are developed within the Radio Matters working group of ETSI technical committee Electromagnetic Compatibility and Radio Spectrum Matters (ERM), and communicated to the CEPT as the basis of European radio frequency harmonization measures.

eHealth standards are studies which take into consideration ETSI standards having an influence on eHealth and future needs for the ICT health sector.

Radio Spectrum Standards

ETSI has developed System Reference Documents for the following medical applications:

  • UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy
  • inductive Ultra Low Power Active Medical Implants (ULP- AMI) in the band 9 kHz to 315 kHz
  • 30-37.5 MHz 'membrane implant' ULP-AMI
  • Ultra Low Power Animal Implant Devices (ULP-AID) 12.5 MHz to 20 MHz and 315 kHz - 600 kHz
  • ULP AMI in 401 to 401 MHz & 405 to 406 MHz
  • Low Power Cochlear Implant Systems (LP-CIS)
  • Medical Body Area Network Systems (MBANSs)
  • Ultra Low Power Active Medical Implants (ULP-AMI) operating on very low duty cycles (< 0.01%).

Harmonised Standards

All radio equipment placed on the European market is required to comply with the Radio Equipment Directive (RED). This sets requirements on safety, ElectroMagnetic Compatibility (EMC) and correct use of the radio spectrum to avoid harmful interference.

Standards related to safety for medical devices are available from CENELEC.
EMC standards are developed and maintained by the EMC working group of ETSI technical committee Electromagnetic Compatibility and Radio Spectrum Matters (ERM).

A full list of related standards in the public domain is accessible via the ETSI standards search. Via this interface you can also subscribe for alerts on updates of ETSI standards.