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.
Our Role & Activities
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.
Within the ERM group, the technical group TG30 has primary responsibility:
- to propose and elaborate product specific standards for radiocommunications equipment in connection with medical devices, where the Generic Standards are not applicable or suitable for the application
- to prepare draft SRDocs addressing frequency allocation matters in relation with radiocommunications applications for medical devices
- to cover all aspects specific to medical telemetry transmitting devices and all medical implant telemetry device specifications/standards
This technical group has interactions, through ERM, with som external organizations as the US Food and Drugs Administration and with CEPT WGFM/SRDMG about the bands dedicated for Ultra Low Power Animal Implantable Devices (ULP-AID) equipment.
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%).
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 Harmonised standard EN 303 520 for wireless medical capsule endoscopy devices has been published and cited in EUOJ with restriction.
A full list of related standards in the public domain is accessible via the ETSI standards search.