ETSI EN 301 839-1:2007
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

Standard No.

ETSI EN 301 839-1:2007

Release Date

2007

Published By

ETSI - European Telecommunications Standards Institute

Status

Be replaced 2014-04

Replace By

ETSI EN 301 839-1:2009

Latest

ETSI EN 301 839-1:2015

Scope

The present document covers@ for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS)@ the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of implant users. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Also included in the present document is the capability of Low Duty Cycly/Low Power Access in the 403@5 MHz to 403@8 MHz frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC (RTTE Directive) [1]. It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for ULP-AMI radio equipment which is also addressed by CEPT/ERC/REC 70-03 [2] and annex 12 to that document. It does not necessarily include all the characteristics@ which may be required by a user@ nor does it necessarily represent the optimum performance achievable. It applies to ULP-AMI devices and accessories operating in the band 402 MHz to 405 MHz: - for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or - for telecommand and telemetry to/from an AIMD to another AIMD within the human body; - with or without an integral antenna; and/or - with an antenna connection provided only for the purpose of connecting an external dedicated antenna. The present document covers requirements for radiated emissions above 25 MHz.

ETSI EN 301 839-1:2007 history

• 2015 ETSI EN 301 839-1:2015 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 (V2.1.0)
• 2009 ETSI EN 301 839-1:2009 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
• 2007 ETSI EN 301 839-1:2007 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
• 2006 ETSI EN 301 839-1:2006 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
• 2002 ETSI EN 301 839-1:2002 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Radio Equipment in the Frequency Range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical Characteristics@ Including Electromagnetic Compatibili
• 2001 ETSI EN 301 839-1:2001 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Radio Equipment in the Frequency Range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical Characteristics@ Including Electromagnetic Compatibili
• 2000 ETSI EN 301 839-1:2000 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Radio Equipment in the Frequency Range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical Characteristics@ Including Electromagnetic Compatibili