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HARMONISED EUROPEAN STANDARD
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 27: Specific conditions for Ultra Low
Power Active Medical Implants (ULP-AMI) and
related peripheral devices (ULP-AMI-P) operating
in the 402 MHz to 405 MHz bands;
Harmonised Standard covering the essential requirements
of article 3.1(b) of Directive 2014/53/EU
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2 ETSI EN 301 489-27 V2.2.1 (2019-04)
Reference
REN/ERM-EMC-374
Keywords
EMC, harmonised standard, radio, regulation,
short range
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3 ETSI EN 301 489-27 V2.2.1 (2019-04)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 7
3 Applicability, definitions and abbreviations . 7
3.0 Applicability . 7
3.1 Definitions . 7
3.2 Abbreviations . 8
4 Test conditions . 8
4.1 General . 8
4.2 Arrangements for test signals . 9
4.2.0 General . 9
4.2.1 Arrangements for test signals at the input of transmitters . 9
4.2.2 Arrangements for test signals at the RF output of transmitters . 9
4.2.2.1 General . 9
4.2.2.2 ULP-AMI transmitters . 9
4.2.2.3 ULP-AMI-P transmitters . 9
4.2.3 Arrangements for test signals at the RF input of receivers . 9
4.2.4 Arrangements for test signals at the output of receivers . 9
4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an
associated ULP-AMI-P) . 10
4.3 RF exclusion band of radio equipment . 10
4.3.0 General . 10
4.3.1 Exclusion bands for receivers . 10
4.3.2 Exclusion band for transmitters . 11
4.4 Narrow band responses of receivers or receivers which are part of transceivers . 11
4.5 Normal test modulation . 11
5 Performance assessment . 11
5.1 General . 11
5.2 Equipment which can provide a continuous communication link . 11
5.3 Equipment which does not provide a continuous communication link . 12
5.4 Ancillary equipment . 12
5.5 Equipment classification . 12
6 Performance criteria . 12
6.1 classification of ULP-AMI and ULP-AMI-P devices . 12
6.2 General performance criteria . 12
6.3 Performance criteria and table . 13
6.4 Performance criteria for continuous phenomena applied to transmitters . 14
6.5 Performance criteria for transient phenomena applied to transmitters . 14
6.6 Performance criteria for continuous phenomena applied to receivers . 14
6.7 Performance criteria for transient phenomena applied to receivers . 15
7 Applicability overview . 15
7.1 EMC emission . 15
7.1.1 General . 15
7.1.2 Special conditions . 15
7.2 Immunity . 15
7.2.1 General . 15
7.2.2 Special conditions . 15
ETSI
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4 ETSI EN 301 489-27 V2.2.1 (2019-04)
Annex A (informative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 19
Annex B (normative): Definitions of types of ULP-AMI and ULP-AMI-P devices in the
scope of the present document . 21
B.1 ULP-AMI and ULP-AMI-P devices intended for operation in the frequency range 402 MHz to
405 MHz . 21
Annex C (normative): Test fixture for ULP-AMI (Simulated man) . 22
Annex D (informative): Change history . 24
History . 25
ETSI
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5 ETSI EN 301 489-27 V2.2.1 (2019-04)
Intellectual Property Rights
Essential patents
IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (https://ipr.etsi.org/).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Trademarks
The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.
ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no
right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does
not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.
Foreword
This Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM).
The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.4] to
provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU 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 [i.1].
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive and associated
EFTA regulations.
The present document is part 27 of a multi-part deliverable. Full details of the entire series can be found in part 1 [1].
National transposition dates
Date of adoption of this EN: 20 June 2017
Date of latest announcement of this EN (doa): 31 July 2019
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 January 2020
Date of withdrawal of any conflicting National Standard (dow): 31 January 2021
Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and
"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of
provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
ETSI
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6 ETSI EN 301 489-27 V2.2.1 (2019-04)
1 Scope
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Ultra Low Power Active Medical Implants (ULP-AMIs) and associated Peripheral ULP-AMI-Ps) in respect of
ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of ULP-AMI and ULP-AMI-P devices.
Technical specifications related to the antenna port and emissions from the enclosure port of the ULP-AMI and
ULP-AMI-P devices radio system 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
ULP-AMIs and associated Peripheral devices (ULP-AMI-Ps).
Definitions of types of ULP-AMIs and ULP-AMI-Ps covered by present document are given in annex B.
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 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].
2 References
2.1 Normative references
References are specific, identified by date of publication and/or edition number or version number. Only the cited
version applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
https://docbox.etsi.org/Reference/.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
[1] ETSI EN 301 489-1 (V2.2.0) (03-2017): "ElectroMagnetic Compatibility (EMC) standard for
radio equipment and services; Part 1: Common technical requirements; Harmonised Standard
covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential
requirements of article 6 of Directive 2014/30/EU".
[2] ETSI EN 301 839 (V2.1.1) (04-2016): "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".
[3] CENELEC EN 61000-4-5 (2006): "Electromagnetic compatibility (EMC) - Part 4-5: Testing and
measurement techniques - Surge immunity test".
ETSI
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7 ETSI EN 301 489-27 V2.2.1 (2019-04)
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] 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.
[i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.3] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave
Frequencies", Physics Department, King's College, London WC2R 2LS, UK. February 1996.
NOTE: Available at http://www.dtic.mil/dtic/tr/fulltext/u2/a305826.pdf.
[i.4] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electrotechnical Standardisation and to the European
Telecommunications Standards Institute as regards radio equipment in support of Directive
2014/53/EU of the European Parliament and of the Council.
[i.5] Italian National Research Council, Institute for Applied Physics.
NOTE: Available at http://niremf.ifac.cnr.it/.
3 Applicability, definitions and abbreviations
3.0 Applicability
For the purposes of the present document, definitions and abbreviations have the meanings ascribed herein in clause 3.
Where such meanings are not so ascribed the meanings in ETSI EN 301 489-1 [1], clause 3, apply.
Where such meanings are not so ascribed the meanings in ETSI EN 301 839 [2], clause 3, apply.
Where such meanings are not so ascribed the meanings in the Directive 2014/53/EU [i.1] apply.
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
Active Medical Implant (AMI): diagnostic or therapeutic device designed to be implanted in a human body containing
a power source and a transceiver using the 402 MHz to 405 MHz frequency band for the purpose of providing a
two-way digital communications link
environmental profile: range of environmental conditions under which equipment within the scope of the present
document is required to comply with the provisions of the present document
life supporting equipment: equipment whose continued normal operation is required in order to sustain life
Medical Implant Communications Link (MICL): collections of transmission that may or may not be continuous,
between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient
related information in communications service
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8 ETSI EN 301 489-27 V2.2.1 (2019-04)
Medical Implant Communications System (MICS): specific system providing radiocommunications between an
ULP-AMI and an associated ULP-AMI-P
Ultra Low Power Active Medical Implant (ULP-AMI): transmitter or receiver or transceiver forming part of an
active medical implant, that is used in a medical implant communications system radio link set up by the peripheral
device (ULP-AMI-P)
Ultra Low Power Active Medical Implant Peripheral device (ULP-AMI-P): radio part of equipment outside the
human body, including body worn devices, used to program and/or control an ULP-AMI by means of a Medical
Implant (radio) Communications Link (MICL), such as an external programmer or control transceiver
3.2 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AC Alternating Current
AIMD Active Implantable Medical Device
AMI Active Medical Implant
DC Direct Current
EMC ElectroMagnetic Compatibility
ERP Effective Radiated Power
EUT Equipment Under Test
ISM Industrial, Scientific and Medical
MICL Medical Implant Communications Link
MICS Medical Implant Communications System
RF Radio Frequency
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral device
4 Test conditions
4.1 General
For the purposes of the present document, the test conditions of the ETSI EN 301 489-1 [1], clause 4, shall apply as
appropriate. Further product related test conditions for ULP-AMI and associated ULP-AMI-P are specified in the
present document.
For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present
document, clauses 4.1 to 4.5 shall apply.
Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the
antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with
several types of antenna the test shall be repeated for each type of antenna.
ULP-AMI devices (active medical implants) are designed to be implanted within a human body. These radio systems
are isolated from disturbances by the surrounding body tissue. In order to adequately assess the EMC characteristics of
active medical implants devices , the use of a simulated man is necessary. See annex C for additional details. The
provisions of annex C are intended to provide an operational environment that simulates, to the extent possible, actual
usage conditions for internal implanted devices. It is necessary to use this or another appropriate special fixture when
making emission measurements and immunity tests with radiated RF fields.
ETSI
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9 ETSI EN 301 489-27 V2.2.1 (2019-04)
4.2 Arrangements for test signals
4.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2 shall apply.
4.2.1 Arrangements for test signals at the input of transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications:
• The transmitter shall be modulated with normal test modulation as specified for that type of equipment
(clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall
be used.
4.2.2 Arrangements for test signals at the RF output of transmitters
4.2.2.1 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification:
• The manufacturer may provide a suitable companion receiver or another device that can be used to set up a
communications link and/or to receive messages.
4.2.2.2 ULP-AMI transmitters
For ULP-AMI transmitters the test fixture described in annex C may be used.
The manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the medical
implant communications link.
4.2.2.3 ULP-AMI-P transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications:
• ULP-AMI-Ps are designed to be used external to a human body;
• the manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the
medical implant communications link.
4.2.3 Arrangements for test signals at the RF input of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.3 shall apply with the following modifications:
• the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as
specified for that type of equipment (clause 4.5);
• the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level of the receiver, but
in all cases it shall be below the overload characteristics of the receiver;
• the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant
communications link.
4.2.4 Arrangements for test signals at the output of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate:
• If direct access to the receiver output of the ULP-AMI and associated ULP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
ETSI
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10 ETSI EN 301 489-27 V2.2.1 (2019-04)
4.2.5 Arrangements for testing transmitter and receiver together
(as a system: ULP-AMI together with an associated ULP-AMI-P)
The provisions of ETSI EN 301 489-1 [1], clause 4.2.5 shall apply with the following modification:
• The transmitter of an ULP-AMI and the receiver of an associated ULP-AMI-P or the receiver of an ULP-AMI
and the transmitter of an associated ULP-AMI-P may be tested together, if appropriate and agreed by the
manufacturer and the test laboratory (size of devices, etc.).
• In this case both EUTs shall be located in their respective test environment and exposed simultaneously to the
EMC phenomena.
4.3 RF exclusion band of radio equipment
4.3.0 General
The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the
clauses 4.3.1 and 4.3.2.
The frequencies on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity
tests.
The frequencies on which the transmitter part of the EUT is intended to operate shall be excluded from emission
measurements when performed in transmit mode of operation.
During emission measurements, a frequency exclusion band does not apply for the receiver part of ULP-AMIs and/or
associated ULP-AMI-Ps.
4.3.1 Exclusion bands for receivers
The exclusion band for receivers (including receivers that are part of transceivers) is determined as follows:
• for receivers capable of operating on 9 or more channels within the frequency band specified in table 1 and not
having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used
frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is
the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated
extension value shall be based on the operating frequency;
• for receivers capable of operating on more than one frequency and having an alignment range, the lower
frequency of the exclusion band is the lower frequency of the alignment range minus the extension value given
in table 1, and the upper frequency of the exclusion band is the upper frequency of the alignment range plus
the extension value given in table 1. The calculated extension values shall be based on the centre frequency of
the alignment range;
• for wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the
exclusion band is the lower frequency of the intended operating band minus the extension value given in
table 1 and the upper frequency of the exclusion band is the upper frequency of the intended operating band
plus the extension value given in table 1, or the total exclusion band is twice the intended operating frequency
band of the receiver centred around the centre frequency of the intended operating band, whichever is the
greater.
Table 1: Exclusion band for the receiver part of ULP-AMI or ULP-AMI-Ps
Receiver operating Receiver exclusion band
frequency f
o
402 MHz to 405 MHz
f ± 10 MHz
o
ETSI
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