Medical

 
 
 
 

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 Harmonized 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 in the ETSI eHealth Project -where current ETSI standards that help and future needs for the ICT health sector are considered.


Radio Spectrum Standards

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

  • 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  ULP-AID
  • 315 kHz - 600 kHz ULP-AID
  • ULP AMI in 401 to 401 MHz & 405 to 406 MHz.

A System Reference Document is also under development for Ultra Low Power Active Medical Implants (ULP-AMI) operating on very low duty cycles (< 0.1%).

Harmonized Standards

All radio equipment placed on the European market is required to comply with the R&TTE Directive. 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 is a list of recently published and frequently downloaded standards. Please use the ETSI Work Programme to find further related standards.

Standard No. Standard Title
TR 101 981Short Range Devices (SRD);
System Reference Document for inductive Loop - Ultra Low Power Active Medical Implants (ULP- AMI) - systems operating in the frequency bands 9 kHz to 315 kHz
TR 102 309Ultra Low Power Active Medical Implants (ULP-AMI);
'Membrane Implant' devices operating in the 30 MHz to 37,5 MHz band; System Reference Document
TR 102 315Short Range Devices (SRD); Ultra Low Power Animal Implant Devices (ULP-AID) operating in the frequency band: 12,5 MHz to 20 MHz; System Reference Document
TR 102 316Ultra Low Power Animal Implantable Devices (ULP-AID) operating in the frequency band 315 kHz to 600 kHz;
System Reference Document
TR 102 343Ultra Low Power Active Medical Implants (ULP-AMI) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; System Reference Document
EN 301 489-1ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;
Part 1: Common technical requirements
EN 301 489-27ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;
Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)
EN 301 839Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories
EN 302 195Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories