SIST EN 301 559 V2.1.1:2016
(Main)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
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
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.
Naprave kratkega dosega (SRD) - Aktivni medicinski vsadki majhnih moči (LP-AMI) in pripadajoče periferne naprave (LP-AMI-P), ki delujejo v frekvenčnem območju od 2483,5 MHz do 2500 MHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU
Ta dokument zajema zahtevane lastnosti aktivnih medicinskih vsadkov majhnih moči (LP-AMI), ki delujejo v frekvenčnem območju od 2483,5 MHz do 2500 MHz, in pripadajočih perifernih naprav (LP-AMI-P) za uporabo v komunikacijskem sistemu aktivnih medicinskih vsadkov (AMICS), ki so nujno potrebni za učinkovito uporabo razpoložljivega spektra in izpolnjevanje zahtev bolnikov z vsajenimi napravami. Specifikacije v tem dokumentu so bile pripravljene za varovanje zdravja in varnosti bolnikov, ki uporabljajo to opremo po zdravnikovih navodilih. Pomembne so zlasti zahteve za spremljanje spektra in dostop, ki so namenjene za pomembno zmanjšanje morebitne možnosti motenja komunikacijskega sistema aktivnih medicinskih vsadkov, ki deluje v pasu, ali motenja med komunikacijskim sistemom aktivnih medicinskih vsadkov in drugimi primarnimi ali sekundarnimi uporabniki pasu. Aktivne medicinske vsadke majhnih moči ureja Direktiva 90/385/EGS [i.5] o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev; radijske dele, ki jih obravnava (v tem besedilu: medicinski vsadki majhnih moči in pripadajoče periferne naprave), ureja Direktiva 2014/53/EU [i.1].
Pogoji uporabe frekvenc za pasove od 2483,5 MHz do 2500 MHz so v skladu z izvedbenim sklepom Komisije 2013/752/EU [i.13] v celotni Evropski uniji usklajeni za kategorijo naprav kratkega dosega »aktivni medicinski pripomočki za vsaditev« z naslednjimi omejitvami uporabe:
• »Ta niz pogojev uporabe je na voljo samo za aktivne medicinske pripomočke za vsaditev. Periferne glavne enote so namenjene samo za uporabo v zaprtih prostorih.«
Ta dokument vsebuje tehnične lastnosti za radijsko opremo za aktivne medicinske vsadke majhnih moči in pripadajoče periferne naprave, ki je obravnavana tudi v standardu CEPT/ERC/REC 70-03 [i.3] in delu e dodatka 12 k navedenemu dokumentu. Ne vključuje nujno vseh lastnosti, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno optimalnega delovanja.
Ta dokument se uporablja za aktivne medicinske vsadke majhnih moči in pripadajoče periferne naprave, ki delujejo v pasu od 2483,5 MHz do 2500 MHz:
• za daljinsko vodenje in telemetrijo med aktivnim medicinskim vsadkom majhne moči in pripadajočo periferno napravo;
• za daljinsko vodenje in telemetrijo med aktivnim medicinskim vsadkom majhne moči in drugim aktivnim medicinskim vsadkom majhne moči;
• z vgrajeno anteno ali brez nje; in/ali
• z antensko povezavo samo zaradi povezave z ustrezno anteno.
Ta dokument vsebuje zahtevane lastnosti, ki jih morajo izpolnjevati radijske naprave v komunikacijskem sistemu aktivnih medicinskih vsadkov za učinkovito uporabo razpoložljivega spektra za prenos podatkov, ki se uporabljajo za postavitev diagnoze in zdravljenje posameznikov z različnimi boleznimi. Posebno pomembne so zahteve za spremljanje spektra in dostop (navedene pred protokolom govora), ki so namenjene za pomembno zmanjšanje morebitne možnosti motenja komunikacijskega sistema aktivnih medicinskih vsadkov, ki deluje v pasu, ali motenja med komunikacijskim sistemom aktivnih medicinskih vsadkov in primarnimi uporabniki pasu. Ta dokument je standard za specifičen proizvod, ki se uporablja za oddajnike majhnih moči v okviru sistema, ki se uporablja v komunikacijskem sistemu aktivnih medicinskih vsadkov in deluje v pasu frekvenčnega spektra od 2483,5 MHz do 2500 MHz.
Ta dokument vsebuje zahteve, s katerimi se dokazuje, da so aktivni medicinski vsadki majhnih moči »... izdelani tako, da optimalno uporabljajo in tudi podpirajo učinkovito rabo radijskega spektra z namenom preprečevanja škodljivih motenj« (člen 3.2 Direktive 2014/53/EU) [i.1]. Ta dokument ne vključuje nujno vseh zahtev, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno optimalnega delovanja.
General Information
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 301 559 V2.1.1:2016
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
SIST EN 301 559 V2.1.1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 301 559 V2.1.1:2016
---------------------- Page: 2 ----------------------
SIST EN 301 559 V2.1.1:2016
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
---------------------- Page: 3 ----------------------
SIST EN 301 559 V2.1.1:2016
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
---------------------- Page: 4 ----------------------
SIST EN 301 559 V2.1.1:2016
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
---------------------- Page: 5 ----------------------
SIST EN 301 559 V2.1.1:2016
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
---------------------- Page: 6 ----------------------
SIST EN 301 559 V2.1.1:2016
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
...
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
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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
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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
...
Draft ETSI EN 301 559 V2.0.1 (2016-06)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI)
and associated Peripherals (LP-AMI-P)
operating in the 2 483,5 MHz to 2 500 MHz range;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 301 559 V2.0.1 (2016-06)
Reference
REN/ERM-TG30-314
Keywords
Harmonised standard, health, radio, regulation,
SRD, testing
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ETSI
---------------------- Page: 2 ----------------------
3 Draft ETSI EN 301 559 V2.0.1 (2016-06)
Contents
Intellectual Property Rights . 7
Foreword . 7
Modal verbs terminology . 7
Introduction . 8
1 Scope . 9
2 References . 9
2.1 Normative references . 9
2.2 Informative references . 10
3 Definitions, symbols and abbreviations . 11
3.1 Definitions . 11
3.2 Symbols . 13
3.3 Abbreviations . 13
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 . 14
4.2.1.2 Emission bandwidth . 14
4.2.1.2.1 Definition. 14
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 . 16
4.2.1.6.3 Conformance . 16
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 . 17
4.2.2.1.3 Conformance . 17
4.2.2.2 Receiver blocking . 18
4.2.2.2.1 Definition. 18
ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 301 559 V2.0.1 (2016-06)
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 . 18
4.2.3.1.1 Definition. 18
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 . 19
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 . 20
4.3.3 Transmitter shut-off facility . 21
4.3.4 Marking . 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
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 301 559 V2.0.1 (2016-06)
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
---------------------- Page: 5 ----------------------
6 Draft ETSI EN 301 559 V2.0.1 (2016-06)
B.2 Guidance on the use of radiation test sites . 50
B.2.0 General requirement . 50
B.2.1 Measuring distance .
...
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