DS/EN 302 195 V2.1.1:2016

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


Status:
Current
Type:
Standard
Language:
EN
Price from:
€ 19.45
Legislation:

Legislation

Harmonized under:
  • Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC Text with EEA relevance

Harmonized standards:
Links

Scope

The present document applies to Ultra Low Power Active Medical Implants (ULP-AMI) transmitters and receivers: – transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m; – receivers operating in the range from 9 kHz to 315 kHz. The present document applies to ULP-AMI devices: – either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna; – for telecommand, telemetry etc. applications; – for all types of digital modulation; – with or without speech. The present document covers fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient). All types of digital modulation for implanted radio devices and associated accessories are covered by the present document.

Number of pages: 38

Published: 2016-07-14

Date of approval: 2016-07-07

International relationships:

ICS: 33.100.01 - Electromagnetic compatibility in general 33.100.10 - Emission

Item number: M309290


Committees

Committee

  • ETSI/TR & TS

Danish committee

DS/V-002