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.
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:
This technical group has interactions, through ERM, with some external organizations such 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 that take into consideration ETSI standards that have an influence on eHealth and future needs for the ICT health sector.
ETSI has developed standards and/or System Reference Documents relevant to the following medical applications:
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:
A full list of related standards in the public domain is accessible via the ETSI standards search.