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ETSI - EN 301 839-1

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

pending
Organization: ETSI
Publication Date: 1 July 2015
Status: pending
Page Count: 50
scope:

The present document applies to the following radio equipment types:

• Ultra Low Power Active Medical Implants (ULP-AMI).

• Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P).

These radio equipment types are capable of operating in all or any part of the frequency bands

The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1].

It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency 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.

The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS)" ... shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.

Document History

EN 301 839-1
July 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
The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI). • Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P). These...
EN 301 839-1
October 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 and test methods
A description is not available for this item.
EN 301 839-1
July 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 and test methods
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...
EN 301 839-1
January 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 and test methods
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...
EN 301 839-1
July 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 and test methods
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...
EN 301 839-1
May 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 and test methods
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...
EN 301 839-1
June 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 Compatibility Requirements, and Test Methods
The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered...
EN 301 839-1
April 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 Compatibility Requirements, and Test Methods
The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered...
EN 301 839-1
July 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 Compatibility Requirements, and Test Methods
The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered...
EN 301 839-1
December 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 Compatibility Requirements, and Test Methods
The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered...
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References

This document references:
CEPT/ERC/REC 74-01 E - Spurious Emissions
Published by CEPT on January 1, 1998
A description is not available for this item.
This document references:
TR 100 028-1 - Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Uncertainties in the Measurement of Mobile Radio Equipment Characteristics; Part 1
Published by ETSI on December 1, 2001
A description is not available for this item.
This document references:
EC 1999/5/EC - Directive of the European Parliament and of the Council on Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of Their Conformity
Published by EEC on March 9, 1999
A description is not available for this item.
This document references:
EC 2014/53/EU - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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
Published by EEC on April 16, 2014
A description is not available for this item.
This document references:
90/385/EEC - Commission Communication in the Framework of the Implementation of Council Directive in Relation to Active Implantable Medical Devices (1), and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices (2)
Published by EU on June 20, 1990
A description is not available for this item.
This document references:
IEC CISPR 16-2-3 - Specification for radio disturbance and immunity measuring apparatus and methods – Part 2-3: Methods of measurement of disturbances and immunity – Radiated disturbance measurements
Published by IEC on June 1, 2019
This part of CISPR 16 specifies the methods of measurement of radiated disturbance phenomena in the frequency range of 9 kHz to 18 GHz. The aspects of measurement uncertainty are specified in CISPR...
This document references:
ITU-R RS.1346 - SHARING BETWEEN THE METEOROLOGICAL AIDS SERVICE AND MEDICAL IMPLANT COMMUNICATION SYSTEMS (MICS) OPERATING IN THE MOBILE SERVICE IN THE FREQUENCY BAND 401-406 MHz
Published by ITU-R on January 1, 1998
A description is not available for this item.
This document references:
ITU-T O.153 - Basic Parameters for the Measurement of Error Performance at Bit Rates Below the Primary Rate
Published by ITU-T on October 1, 1992
A description is not available for this item.
This document references:
CISPR 16-1 - Specification for Radio Disturbance and Immunity Measuring Apparatus and Methods - Part 1: Radio Disturbance and Immunity Measuring Apparatus
Published by IEC on October 1, 2002
A description is not available for this item.
This document is referenced by:
TR 103 088 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Using the EN 301 489 series of EMC standards
Published by ETSI on July 1, 2019
The present document is intended to provide guidance on the use of the ETSI EN 301 489 series [i.2] of harmonised EMC standards produced by ETSI ERM. Specifically this guidance covers selection of...
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