Medical

Introduction

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.

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:

  • 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%).

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).

Standards

The following is a list of the 20 latest published ETSI standards on medical.

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.

For work in progress see the ETSI Work Programme on the Portal.

Standard No. Standard title.
EN 302 195 Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
EN 301 559 Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
EN 302 537 Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
EN 303 203 Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
EN 301 839 Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
EN 303 203-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
EN 303 203-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 1: Technical characteristics and test methods
TR 103 069 Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference Document (SRDoc); Short Range Devices; Low Power Cochlear Implant Systems (LP-CIS) operating in the band 2 483,5 MHz - 2 500 MHz
EN 301 559-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
EN 301 559-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 1: Technical characteristics and test methods
TR 101 557 Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference document (SRdoc); Medical Body Area Network Systems (MBANSs) in the 1 785 MHz to 2 500 MHz range
EN 301 839-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 301 839-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteristics and test methods
TR 102 764 eHEALTH; Architecture; Analysis of user service models, technologies and applications supporting eHealth
EN 302 537-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 302 536-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 302 537-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 1: Technical characteristics and test methods
EN 302 536-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 1: Technical characteristics and test methods
EN 302 510-2 Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 302 510-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 1: Technical characteristics and test methods