ETSI is developing a number of standards for medical devices implanted in the human body and communicating 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 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 to 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 some 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 standards and/or System Reference Documents relevant to the following medical applications:
- UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy in the band 430 MHz to 440 MHz (reference standard: EN 303 520)
- Inductive Ultra Low Power Active Medical Implants (ULP- AMI) in the band 9 kHz to 315 kHz (reference standard: EN 302 195)
- Ultra Low Power Active Medical Membrane Implants (ULP-AMI) in the band 30 – 37.5 MHz (reference standard: EN 302 510)
- Ultra Low Power Animal Implant Devices (ULP-AID) in the bands 12.5 MHz to 20 MHz and 315 kHz - 600 kHz (reference standard: EN 302 536)
- Ultra Low Power Medical Data Services (MEDS) in the bands 401 to 402 MHz & 405 to 406 MHz (reference standard: EN 302 537)
- ULP AMI in 402 to 405 MHz (reference standard: EN 301 839)
- Ultra Low Power Active Medical Implants (ULP-AMI) operating with very low duty cycle (< 0.01%) in the band 403.5 MHz to 403.8 MHz (reference standard: EN 301 839)
- Low Power Cochlear Implant Systems (LP-CIS)
- Medical Body Area Network Systems (MBANSs) in the band 2 483.5 – 2 500 MHz (reference standard: EN 303 203)
- Low Power Active Medical Implants (LP-AMI) in the band 2 483.5 – 2 500 MHz (reference standard: EN 301 559)
- On-Site Paging Service (reference standard: EN 300 224)
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).
The following radio spectrum standards, relevant to medical applications, have published Harmonised versions cited in the EUOJ:
- EN 302 195
- EN 302 510 (cited with restrictions)
- EN 303 520 (cited with restrictions)
- EN 302 536 (cited with restrictions)
- EN 301 839
- EN 303 203
- EN 301 559
- EN 302 537
- EN 300 224 (cited with restrictions)
A full list of related standards in the public domain is accessible via the ETSI standards search.