DS/EN 301 489-31 V2.1.1:2016

ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of the Directive 2014/53/EU

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The present document together with ETSI EN 301 489-1 [1] covers the assessment of all radio transceivers associated
with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range
from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range
of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of
ElectroMagnetic Compatibility (EMC). Non-radio parts of the above equipment may be covered by other directives
and/or standards when applicable.
Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these
devices are not included in the present document. Such technical specifications are found in the relevant product
standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for
assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of
electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].

Number of pages: 25

Published: 2016-12-08

Date of approval: 2016-12-02

International relationships: ETSI EN 301 489-31 V2.1.1 (2016-11) IDT

ICS: 33.100.01 - Electromagnetic compatibility in general 33.100.10 - Emission

Item number: M309413



  • ETSI/TR & TS

Danish committee