ETSI EN 301 559 V2.1.1 (2016-10)

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI)
and associated Peripherals (LP-AMI-P)
operating in the frequency range 2 483,5 MHz to 2 500 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 ETSI EN 301 559 V2.1.1 (2016-10)

Reference
REN/ERM-TG30-314
Keywords
harmonised standard, health, radio, regulation,
SRD, testing
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
The present document can be downloaded from:
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The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
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Users of the present document should be aware that the document may be subject to revision or change of status.
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If you find errors in the present document, please send your comment to one of the following services:
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The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.

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ETSI
3 ETSI EN 301 559 V2.1.1 (2016-10)
Contents
Intellectual Property Rights . 7
Foreword . 7
Modal verbs terminology . 7
Introduction . 8
1 Scope . 9
2 References . 10
2.1 Normative references . 10
2.2 Informative references . 10
3 Definitions, symbols and abbreviations . 11
3.1 Definitions . 11
3.2 Symbols . 13
3.3 Abbreviations . 14
4 Technical requirements and specifications . 14
4.1 Environmental profile . 14
4.2 Conformance requirements . 14
4.2.1 Transmitter requirements . 14
4.2.1.1 Frequency Error . 14
4.2.1.1.1 Definition. 14
4.2.1.1.2 Limits . 14
4.2.1.1.3 Conformance . 15
4.2.1.2 Emission bandwidth . 15
4.2.1.2.1 Definition. 15
4.2.1.2.2 Limits . 15
4.2.1.2.3 Conformance . 15
4.2.1.3 Effective isotropic radiated power of the fundamental emission . 15
4.2.1.3.1 Definition. 15
4.2.1.3.2 Limits . 15
4.2.1.3.3 Conformance . 15
4.2.1.4 Spurious emissions . 15
4.2.1.4.1 Definition. 15
4.2.1.4.2 Limits . 15
4.2.1.4.3 Conformance . 16
4.2.1.5 Out-of-band emissions . 16
4.2.1.5.1 Definition. 16
4.2.1.5.2 Limits . 16
4.2.1.5.3 Conformance . 16
4.2.1.6 Frequency stability under low voltage conditions . 16
4.2.1.6.0 Applicability . 16
4.2.1.6.1 Definition. 16
4.2.1.6.2 Limits . 17
4.2.1.6.3 Conformance . 17
4.2.1.7 LP-AMI-P with restricted duty cycle . 17
4.2.1.7.0 General remarks. 17
4.2.1.7.1 Definition. 17
4.2.1.7.2 Limits . 17
4.2.1.7.3 Conformance . 17
4.2.2 Receiver requirements . 17
4.2.2.1 Spurious radiation . 17
4.2.2.1.0 General provision . 17
4.2.2.1.1 Definition. 17
4.2.2.1.2 Limits . 18
4.2.2.1.3 Conformance . 18
4.2.2.2 Receiver blocking . 18
4.2.2.2.1 Definition. 18
ETSI
4 ETSI EN 301 559 V2.1.1 (2016-10)
4.2.2.2.2 Limits . 18
4.2.2.2.3 Conformance . 18
4.2.3 Spectrum access . 18
4.2.3.0 General requirements . 18
4.2.3.1 LBT threshold power level . 19
4.2.3.1.1 Definition. 19
4.2.3.1.2 Limits . 19
4.2.3.1.3 Conformance . 19
4.2.3.2 Monitoring system bandwidth . 19
4.2.3.2.0 General remarks. 19
4.2.3.2.1 Definition. 19
4.2.3.2.2 Limits . 19
4.2.3.2.3 Conformance . 20
4.2.3.3 Minimum channel monitoring period . 20
4.2.3.3.0 General remarks. 20
4.2.3.3.1 Definition. 20
4.2.3.3.2 Limits . 20
4.2.3.3.3 Conformance . 20
4.2.3.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 20
Th
4.2.3.4.0 General requirements . 20
4.2.3.4.1 Conformance . 20
4.3 Mechanical and electrical design . 20
4.3.1 General . 20
4.3.2 Controls . 21
4.3.3 Transmitter shut-off facility . 21
4.3.4 Void . 21
4.3.5 Equipment identification . 21
5 Testing for compliance with technical requirements . 21
5.1 Environmental conditions for testing . 21
5.1.0 General requirements . 21
5.1.1 Presentation of equipment for testing purposes . 21
5.1.1.0 General provisions . 21
5.1.1.1 Choice of model for testing . 21
5.1.1.2 Spurious emission testing for composite equipment . 22
5.1.1.3 Testing of equipment with alternative power levels . 22
5.1.1.4 Presentation of equipment that does not have an external RF connector (integral antenna
equipment) . .22
5.1.1.4.1 Equipment with an internal permanent or temporary antenna connector . 22
5.1.1.4.2 Equipment with a temporary antenna connector . 22
5.1.1.4.3 Equipment intended to be implanted in a human body . 23
5.1.2 Declarations by the applicant . 23
5.1.3 Auxiliary test equipment . 23
5.1.4 Test conditions . 23
5.1.4.1 Normal and extreme test conditions . 23
5.1.4.2 Test power source . 23
5.1.4.2.0 General requirements . 23
5.1.4.2.1 External test power source . 23
5.1.4.2.2 Internal test power source . 23
5.1.4.3 Normal test conditions . 24
5.1.4.3.1 Normal temperature and humidity . 24
5.1.4.3.2 Normal test power source . 24
5.1.4.3.2.1 Mains voltage . 24
5.1.4.3.2.2 Other power sources . 24
5.1.4.4 Extreme test conditions . 24
5.1.4.4.1 Extreme temperatures . 24
5.1.4.4.2 Extreme test source voltages . 26
5.1.4.5 Normal test signals and test modulation. 26
5.1.4.5.0 General requirements . 26
5.1.4.5.1 Normal modulation test signals for data . 26
5.1.4.6 Antennas . 26
5.1.4.7 Artificial Antennas . 26
ETSI
5 ETSI EN 301 559 V2.1.1 (2016-10)
5.1.4.8 Artificial antenna for transmitters with 50 Ω impedance connector . 26
5.1.4.9 Test fixture for LP-AMI-P . 27
5.1.4.10 Test fixture for LP-AMI . 27
5.1.4.11 Test sites and general arrangements for radiated measurements . 27
5.1.4.12 Modes of operation of the transmitter . 27
5.1.4.13 Measuring receiver . 28
5.2 Interpretation of the measurement results . 28
5.3 Methods of measurement . 29
5.3.1 Methods of measurement for transmitters . 29
5.3.1.0 General provision . 29
5.3.1.1 Frequency error . 30
5.3.1.1.0 General requirements . 30
5.3.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 30
5.3.1.1.2 Method of measurement for systems with a modulated output frequency . 30
5.3.1.2 Emission bandwidth . 30
5.3.1.3 Effective isotropic radiated power of the fundamental emission . 31
5.3.1.4 Transmitter spurious emissions . 32
5.3.1.5 Out-of-band emissions . 33
5.3.1.6 Frequency stability under low voltage conditions . 34
5.3.2 Methods of measurement for receivers . 34
5.3.2.0 General provisions . 34
5.3.2.1 Receiver spurious emissions . 34
5.3.2.1 Receiver Blocking . 34
5.3.2.1.0 General remarks. 34
5.3.2.1.1 Measurement method using frequency administration commands . 35
5.3.2.1.2 Results based on the above test method . 35
5.3.3 Methods of measurement for Monitoring Systems . 35
5.3.3.0 Purpose . 35
5.3.3.1 General Remarks on the Measurement Configuration . 36
5.3.3.2 LBT threshold power level . 36
5.3.3.2.0 General Remarks . 36
5.3.3.2.1 Measurement method using out-of-operating-region disturbance . 36
5.3.3.2.2 Measurement method using frequency administration commands . 37
5.3.3.2.3 Measurement method for LBT operation under interference condition . 37
5.3.3.2.3 Results based on above test method . 37
5.3.3.3 Monitoring system bandwidth . 37
5.3.3.3.0 General Remarks . 37
5.3.3.3.1 Measurement method using out-of-operating-region disturbance . 38
5.3.3.3.2 Measurement method using frequency administration commands . 38
5.3.3.3.3 Results based on above test method . 38
5.3.3.4 Monitoring system scan cycle time and minimum channel monitoring period . 39
5.3.3.4.0 General Remarks . 39
5.3.3.4.1 Measurement method using out-of-operating-region disturbance . 39
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 44
Annex B (normative): Radiated measurements . 45
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 45
B.1.1 Outdoor test site . 45
B.1.1.0 General requirement . 45
B.1.1.1 Standard position . 45
B.1.1.2 Equipment in close proximity to the human body but external to it . 46
B.1.1.3 Applicative simulator . 46
B.1.1.3.1 General matters . 46
B.1.1.3.2 Vertical Human torso simulator for LP-AMI . 46
B.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 47
B.1.2 Test antenna . 48
B.1.3 Substitution antenna . 48
B.1.4 Optional additional indoor site . 49
ETSI
6 ETSI EN 301 559 V2.1.1 (2016-10)
B.2 Guidance on the use of radiation test sites . 50
B.2.0 General requirement . 50
B.2.1 Measuring distance . 50
B.2.2 Test antenna . 50
B.2.3 Substitution antenna . 50
B.2.4 Artificial antenna . 50
B.2.5 Auxiliary cables . 50
B.3 Further optional alternative indoor test site using an anechoic chamber . 51
B.3.0 General requirements . 51
B.3.1 Example of the construction of a shielded anechoic chamber . 51
B.3.2 Influence of parasitic reflections in anechoic chambers . 51
B.3.3 Calibration of the shielded RF anechoic chamber . 52
Annex C (informative): Bibliography . 54
History . 55

ETSI
7 ETSI EN 301 559 V2.1.1 (2016-10)
Intellectual Property Rights
IPRs essential or potentially essential to the present document 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.
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.12] 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 covers Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P)
operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems reference document for the
equipment, ETSI TR 102 655 [i.2].

National transposition dates
Date of adoption of this EN: 12 September 2016
Date of latest announcement of this EN (doa): 31 December 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2017
Date of withdrawal of any conflicting National Standard (dow): 30 June 2018

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
8 ETSI EN 301 559 V2.1.1 (2016-10)
Introduction
The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to
cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive
(RE-D) [i.1]. The modular structure is shown in ETSI EG 201 399 [i.4].
LP-AMI/LP-AMI-P equipment in the AMICS is a unique technology using the frequency band 2 483,5 MHz to
2 500 MHz, that will provide for example high speed communications capability between individuals with AIMDs and
medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to
individuals with various illnesses. Equipment in the AMICS consists of LP-AMI and/or LP-AMI-P that provide human
therapeutic and diagnostic data storage and analysis capability.
The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and
Peripherals (LP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an
integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing
the characteristics being measured are not expected to be affected.
The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are European wide harmonised for the SRD
category "active medical implant devices" according to 2013/752/EU [i.13].
If equipment, which is available on the market, is required to be checked it should be tested in accordance with the
methods of measurement specified in the present document.
The present document is structured as follows:
• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document
and the definitions of terms and symbols and abbreviations used.
• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter
are primarily designed to minimize the possibility of disturbance between LP-AMI/LP-AMI-P equipment and
other users of the 2 483,5 MHz to 2 500 MHz frequency range.
• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.
• Clause 5.3 specifies the methods of measurement for the parameters specified in clause 4, related to
transmitter, receiver, and spectrum access.
• Annex A (normative) provides an overview of the relationship between the present document and the essential
requirements of the RE-D [i.1].
• Annex B (normative) gives the specifications concerning radiated measurements.
• Annex C (informative) provides the bibliography.

ETSI
9 ETSI EN 301 559 V2.1.1 (2016-10)
1 Scope
The present document covers, for Low Power Active Medical Implants (LP-AMI) using the band bands 2 483,5 MHz to
2 500 MHz, and associated Peripherals (LP-AMI-P) used in an Active Medical Implant Communications System
(AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the
interests of patients with implanted devices. 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 designed to
significantly reduce any interference potential between AMICS operating in the band or between AMICS and other
primary or secondary users of the band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.5] radio parts
contained therein (referred to herein as LP-AMI and LP-AMI-P for associated peripheral devices) are regulated under
the Directive 2014/53/EU [i.1].
The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are EU wide harmonised for the SRD
category "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.13] with
the following usage restrictions:
• "This set of usage conditions is only available to active implantable medical devices. Peripheral master units
are for indoor use only."
The present document contains the technical characteristics for LP-AMI and associated peripherals LP-AMI-P radio
equipment which is also addressed by CEPT/ERC/REC 70-03 [i.3] annex 12 sub-band e) 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.
The present document applies to LP-AMI and LP-AMI_P operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry between LP-AMI and LP-AMI-P;
• for telecommand and telemetry between LP-AMI to another LP-AMI;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting a dedicated antenna.
The present document contains required characteristics considered necessary for the radio devices used in AMICS to
meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and
delivering therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum
monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference
potential between AMICS operating in the band or between an AMICS and the primary users of the band.
The present document is a specific product standard applicable to low power transmitters that are part of a system used
in the AMICS operating in spectrum within the frequency band 2 483,5 MHz to 2 500 MHz.
The present document contains requirements to demonstrate that Low Power Active Medical Implants (LP-AMI)
"…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.1]. The present document does not necessarily include
all the requirements which may be required by a user, nor does it necessarily represent the optimum performance
achievable.
ETSI
10 ETSI EN 301 559 V2.1.1 (2016-10)
2 References
2.1 Normative 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.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://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] CISPR 16-2-3 (2010) +AMD1:2010+AMD2:2014: "Specification for radio disturbance and
immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances
and immunity - Radiated disturbance measurements".
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] ETSI TR 102 655: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI)
operating in a 20 MHz band within 2 360 MHz to 3 400 MHz".
[i.3] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.4] ETSI EG 201 399 (V3.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards for application under the Radio &
Telecommunication Terminal Equipment Directive 1999/5/EC (R&TTE) and a first guide on the
impact of the Radio Equipment Directive 2014/53/EU (RED) on Harmonized Standards".
[i.5] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices (AIMD Directive).
[i.6] CEPT/ERC/REC 74-01: "Unwanted emissions in the spurious domain".
[i.7] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.8] ETSI TR 100 028 (all parts) (V1.4.1) (12-2001): "Electromagnetic compatibility and Radio
spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment
characteristics".
[i.9] Hartsgrove G., Kraszewski A. and Surowiec A.: "Simulated Biological Materials for
Electromagnetic Radiation Absorption Studies", 1987.
ETSI
11 ETSI EN 301 559 V2.1.1 (2016-10)
[i.10] Hartsgrove and Kraszewski: "Composition And Electrical Properties Of A Liquid That Has The
Electrical Properties Of Tissue", 1984.
[i.11] Carl H. Durney, Ph.D., Habib Massoudi, Ph.D., Magdy F. lskander, USAFSAM-TR-85-73:
"Radiofrequency Radiation Dosimetry Handbook (Fourth Edition)".
NOTE: Available at: http://niremf.ifac.cnr.it/docs/HANDBOOK/home.htm.
[i.12] 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 Counci
...

SLOVENSKI STANDARD
01-december-2016
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Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) and
associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2
500 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the
Directive 2014/53/EU
Ta slovenski standard je istoveten z: ETSI EN 301 559 V2.1.1 (2016-10)
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
33.060.01 Radijske komunikacije na Radiocommunications in
splošno general
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI)
and associated Peripherals (LP-AMI-P)
operating in the frequency range 2 483,5 MHz to 2 500 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 ETSI EN 301 559 V2.1.1 (2016-10)

Reference
REN/ERM-TG30-314
Keywords
harmonised standard, health, radio, regulation,
SRD, testing
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
The present document can be downloaded from:
http://www.etsi.org/standards-search
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
https://portal.etsi.org/TB/ETSIDeliverableStatus.aspx
If you find errors in the present document, please send your comment to one of the following services:
https://portal.etsi.org/People/CommiteeSupportStaff.aspx
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2016.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 ETSI EN 301 559 V2.1.1 (2016-10)
Contents
Intellectual Property Rights . 7
Foreword . 7
Modal verbs terminology . 7
Introduction . 8
1 Scope . 9
2 References . 10
2.1 Normative references . 10
2.2 Informative references . 10
3 Definitions, symbols and abbreviations . 11
3.1 Definitions . 11
3.2 Symbols . 13
3.3 Abbreviations . 14
4 Technical requirements and specifications . 14
4.1 Environmental profile . 14
4.2 Conformance requirements . 14
4.2.1 Transmitter requirements . 14
4.2.1.1 Frequency Error . 14
4.2.1.1.1 Definition. 14
4.2.1.1.2 Limits . 14
4.2.1.1.3 Conformance . 15
4.2.1.2 Emission bandwidth . 15
4.2.1.2.1 Definition. 15
4.2.1.2.2 Limits . 15
4.2.1.2.3 Conformance . 15
4.2.1.3 Effective isotropic radiated power of the fundamental emission . 15
4.2.1.3.1 Definition. 15
4.2.1.3.2 Limits . 15
4.2.1.3.3 Conformance . 15
4.2.1.4 Spurious emissions . 15
4.2.1.4.1 Definition. 15
4.2.1.4.2 Limits . 15
4.2.1.4.3 Conformance . 16
4.2.1.5 Out-of-band emissions . 16
4.2.1.5.1 Definition. 16
4.2.1.5.2 Limits . 16
4.2.1.5.3 Conformance . 16
4.2.1.6 Frequency stability under low voltage conditions . 16
4.2.1.6.0 Applicability . 16
4.2.1.6.1 Definition. 16
4.2.1.6.2 Limits . 17
4.2.1.6.3 Conformance . 17
4.2.1.7 LP-AMI-P with restricted duty cycle . 17
4.2.1.7.0 General remarks. 17
4.2.1.7.1 Definition. 17
4.2.1.7.2 Limits . 17
4.2.1.7.3 Conformance . 17
4.2.2 Receiver requirements . 17
4.2.2.1 Spurious radiation . 17
4.2.2.1.0 General provision . 17
4.2.2.1.1 Definition. 17
4.2.2.1.2 Limits . 18
4.2.2.1.3 Conformance . 18
4.2.2.2 Receiver blocking . 18
4.2.2.2.1 Definition. 18
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4 ETSI EN 301 559 V2.1.1 (2016-10)
4.2.2.2.2 Limits . 18
4.2.2.2.3 Conformance . 18
4.2.3 Spectrum access . 18
4.2.3.0 General requirements . 18
4.2.3.1 LBT threshold power level . 19
4.2.3.1.1 Definition. 19
4.2.3.1.2 Limits . 19
4.2.3.1.3 Conformance . 19
4.2.3.2 Monitoring system bandwidth . 19
4.2.3.2.0 General remarks. 19
4.2.3.2.1 Definition. 19
4.2.3.2.2 Limits . 19
4.2.3.2.3 Conformance . 20
4.2.3.3 Minimum channel monitoring period . 20
4.2.3.3.0 General remarks. 20
4.2.3.3.1 Definition. 20
4.2.3.3.2 Limits . 20
4.2.3.3.3 Conformance . 20
4.2.3.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 20
Th
4.2.3.4.0 General requirements . 20
4.2.3.4.1 Conformance . 20
4.3 Mechanical and electrical design . 20
4.3.1 General . 20
4.3.2 Controls . 21
4.3.3 Transmitter shut-off facility . 21
4.3.4 Void . 21
4.3.5 Equipment identification . 21
5 Testing for compliance with technical requirements . 21
5.1 Environmental conditions for testing . 21
5.1.0 General requirements . 21
5.1.1 Presentation of equipment for testing purposes . 21
5.1.1.0 General provisions . 21
5.1.1.1 Choice of model for testing . 21
5.1.1.2 Spurious emission testing for composite equipment . 22
5.1.1.3 Testing of equipment with alternative power levels . 22
5.1.1.4 Presentation of equipment that does not have an external RF connector (integral antenna
equipment) . .22
5.1.1.4.1 Equipment with an internal permanent or temporary antenna connector . 22
5.1.1.4.2 Equipment with a temporary antenna connector . 22
5.1.1.4.3 Equipment intended to be implanted in a human body . 23
5.1.2 Declarations by the applicant . 23
5.1.3 Auxiliary test equipment . 23
5.1.4 Test conditions . 23
5.1.4.1 Normal and extreme test conditions . 23
5.1.4.2 Test power source . 23
5.1.4.2.0 General requirements . 23
5.1.4.2.1 External test power source . 23
5.1.4.2.2 Internal test power source . 23
5.1.4.3 Normal test conditions . 24
5.1.4.3.1 Normal temperature and humidity . 24
5.1.4.3.2 Normal test power source . 24
5.1.4.3.2.1 Mains voltage . 24
5.1.4.3.2.2 Other power sources . 24
5.1.4.4 Extreme test conditions . 24
5.1.4.4.1 Extreme temperatures . 24
5.1.4.4.2 Extreme test source voltages . 26
5.1.4.5 Normal test signals and test modulation. 26
5.1.4.5.0 General requirements . 26
5.1.4.5.1 Normal modulation test signals for data . 26
5.1.4.6 Antennas . 26
5.1.4.7 Artificial Antennas . 26
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5 ETSI EN 301 559 V2.1.1 (2016-10)
5.1.4.8 Artificial antenna for transmitters with 50 Ω impedance connector . 26
5.1.4.9 Test fixture for LP-AMI-P . 27
5.1.4.10 Test fixture for LP-AMI . 27
5.1.4.11 Test sites and general arrangements for radiated measurements . 27
5.1.4.12 Modes of operation of the transmitter . 27
5.1.4.13 Measuring receiver . 28
5.2 Interpretation of the measurement results . 28
5.3 Methods of measurement . 29
5.3.1 Methods of measurement for transmitters . 29
5.3.1.0 General provision . 29
5.3.1.1 Frequency error . 30
5.3.1.1.0 General requirements . 30
5.3.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 30
5.3.1.1.2 Method of measurement for systems with a modulated output frequency . 30
5.3.1.2 Emission bandwidth . 30
5.3.1.3 Effective isotropic radiated power of the fundamental emission . 31
5.3.1.4 Transmitter spurious emissions . 32
5.3.1.5 Out-of-band emissions . 33
5.3.1.6 Frequency stability under low voltage conditions . 34
5.3.2 Methods of measurement for receivers . 34
5.3.2.0 General provisions . 34
5.3.2.1 Receiver spurious emissions . 34
5.3.2.1 Receiver Blocking . 34
5.3.2.1.0 General remarks. 34
5.3.2.1.1 Measurement method using frequency administration commands . 35
5.3.2.1.2 Results based on the above test method . 35
5.3.3 Methods of measurement for Monitoring Systems . 35
5.3.3.0 Purpose . 35
5.3.3.1 General Remarks on the Measurement Configuration . 36
5.3.3.2 LBT threshold power level . 36
5.3.3.2.0 General Remarks . 36
5.3.3.2.1 Measurement method using out-of-operating-region disturbance . 36
5.3.3.2.2 Measurement method using frequency administration commands . 37
5.3.3.2.3 Measurement method for LBT operation under interference condition . 37
5.3.3.2.3 Results based on above test method . 37
5.3.3.3 Monitoring system bandwidth . 37
5.3.3.3.0 General Remarks . 37
5.3.3.3.1 Measurement method using out-of-operating-region disturbance . 38
5.3.3.3.2 Measurement method using frequency administration commands . 38
5.3.3.3.3 Results based on above test method . 38
5.3.3.4 Monitoring system scan cycle time and minimum channel monitoring period . 39
5.3.3.4.0 General Remarks . 39
5.3.3.4.1 Measurement method using out-of-operating-region disturbance . 39
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 44
Annex B (normative): Radiated measurements . 45
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 45
B.1.1 Outdoor test site . 45
B.1.1.0 General requirement . 45
B.1.1.1 Standard position . 45
B.1.1.2 Equipment in close proximity to the human body but external to it . 46
B.1.1.3 Applicative simulator . 46
B.1.1.3.1 General matters . 46
B.1.1.3.2 Vertical Human torso simulator for LP-AMI . 46
B.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 47
B.1.2 Test antenna . 48
B.1.3 Substitution antenna . 48
B.1.4 Optional additional indoor site . 49
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6 ETSI EN 301 559 V2.1.1 (2016-10)
B.2 Guidance on the use of radiation test sites . 50
B.2.0 General requirement . 50
B.2.1 Measuring distance . 50
B.2.2 Test antenna . 50
B.2.3 Substitution antenna . 50
B.2.4 Artificial antenna . 50
B.2.5 Auxiliary cables . 50
B.3 Further optional alternative indoor test site using an anechoic chamber . 51
B.3.0 General requirements . 51
B.3.1 Example of the construction of a shielded anechoic chamber . 51
B.3.2 Influence of parasitic reflections in anechoic chambers . 51
B.3.3 Calibration of the shielded RF anechoic chamber . 52
Annex C (informative): Bibliography . 54
History . 55

ETSI
7 ETSI EN 301 559 V2.1.1 (2016-10)
Intellectual Property Rights
IPRs essential or potentially essential to the present document 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.
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.12] 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 covers Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P)
operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems reference document for the
equipment, ETSI TR 102 655 [i.2].

National transposition dates
Date of adoption of this EN: 12 September 2016
Date of latest announcement of this EN (doa): 31 December 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2017
Date of withdrawal of any conflicting National Standard (dow): 30 June 2018

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
8 ETSI EN 301 559 V2.1.1 (2016-10)
Introduction
The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to
cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive
(RE-D) [i.1]. The modular structure is shown in ETSI EG 201 399 [i.4].
LP-AMI/LP-AMI-P equipment in the AMICS is a unique technology using the frequency band 2 483,5 MHz to
2 500 MHz, that will provide for example high speed communications capability between individuals with AIMDs and
medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to
individuals with various illnesses. Equipment in the AMICS consists of LP-AMI and/or LP-AMI-P that provide human
therapeutic and diagnostic data storage and analysis capability.
The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and
Peripherals (LP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an
integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing
the characteristics being measured are not expected to be affected.
The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are European wide harmonised for the SRD
category "active medical implant devices" according to 2013/752/EU [i.13].
If equipment, which is available on the market, is required to be checked it should be tested in accordance with the
methods of measurement specified in the present document.
The present document is structured as follows:
• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document
and the definitions of terms and symbols and abbreviations used.
• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter
are primarily designed to minimize the possibility of disturbance between LP-AMI/LP-AMI-P equipment and
other users of the 2 483,5 MHz to 2 500 MHz frequency range.
• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.
• Clause 5.3 specifies the methods of measurement for the parameters specified in clause 4, related to
transmitter, receiver, and spectrum access.
• Annex A (normative) provides an overview of the relationship between the present document and the essential
requirements of the RE-D [i.1].
• Annex B (normative) gives the specifications concerning radiated measurements.
• Annex C (informative) provides the bibliography.

ETSI
9 ETSI EN 301 559 V2.1.1 (2016-10)
1 Scope
The present document covers, for Low Power Active Medical Implants (LP-AMI) using the band bands 2 483,5 MHz to
2 500 MHz, and associated Peripherals (LP-AMI-P) used in an Active Medical Implant Communications System
(AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the
interests of patients with implanted devices. 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 designed to
significantly reduce any interference potential between AMICS operating in the band or between AMICS and other
primary or secondary users of the band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.5] radio parts
contained therein (referred to herein as LP-AMI and LP-AMI-P for associated peripheral devices) are regulated under
the Directive 2014/53/EU [i.1].
The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are EU wide harmonised for the SRD
category "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.13] with
the following usage restrictions:
• "This set of usage conditions is only available to active implantable medical devices. Peripheral master units
are for indoor use only."
The present document contains the technical characteristics for LP-AMI and associated peripherals LP-AMI-P radio
equipment which is also addressed by CEPT/ERC/REC 70-03 [i.3] annex 12 sub-band e) 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.
The present document applies to LP-AMI and LP-AMI_P operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry between LP-AMI and LP-AMI-P;
• for telecommand and telemetry between LP-AMI to another LP-AMI;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting a dedicated antenna.
The present document contains required characteristics considered necessary for the radio devices used in AMICS to
meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and
delivering therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum
monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference
potential between AMICS operating in the band or between an AMICS and the primary users of the band.
The present document is a specific product standard applicable to low power transmitters that are part of a system used
in the AMICS operating in spectrum within the frequency band 2 483,5 MHz to 2 500 MHz.
The present document contains requirements to demonstrate that Low Power Active Medical Implants (LP-AMI)
"…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.1]. The present document does not necessarily include
all the requirements which may be required by a user, nor does it necessarily represent the optimum performance
achievable.
ETSI
10 ETSI EN 301 559 V2.1.1 (2016-10)
2 References
2.1 Normative 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.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://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] CISPR 16-2-3 (2010) +AMD1:2010+AMD2:2014: "Specification for radio disturbance and
immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances
and immunity - Radiated disturbance measurements".
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] ETSI TR 102 655: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI)
operating in a 20 MHz band within 2 360 MHz to 3 400 MHz".
[i.3] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.4] ETSI EG 201 399 (V3.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards for application under the Radio &
Telecommunication Terminal Equipment Directive 1999/5/EC (R&TTE) and a first guide on the
impact of the Radio Equipment Directive 201
...