SIST EN 301 839 V2.1.1:2016
(Main)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
Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI).
• Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P).
The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1].
It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz:
• for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or
• for telecommand and telemetry to/from an AIMD to another AIMD within the human body.
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS) "… shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.
Aktivni medicinski vsadki ultra majhnih moči (ULP-AMI) in pripadajoče periferne naprave (ULP-AMI-P), ki delujejo v frekvenčnem območju od 402 MHz do 405 MHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU
Ta dokument se uporablja za radijsko opremo naslednjih vrst:
• aktivni medicinski vsadki ultra majhnih moči (ULP-AMI)
• pripadajoče periferne naprave (ULP-AMI-P)
Ta dokument zajema tehnične karakteristike za radijsko opremo za medicinske vsadke majhnih moči in pripadajoče periferne naprave, ki je obravnavana tudi v standardu ERC/DEC (01)17 [i.1].
Uporablja se za medicinske vsadke majhnih moči in pripadajoče periferne naprave, ki delujejo v frekvenčnem pasu od 402 do 405 MHz:
• za daljinsko vodenje in telemetrijo do/od medicinskega vsadka majhnih moči v bolnikovem telesu do pripadajoče periferne naprave; ali
• za daljinsko vodenje in telemetrijo do/od medicinskega vsadka majhnih moči do drugega medicinskega vsadka majhnih moči v človeškem telesu.
Ta dokument vsebuje zahteve, s katerimi se dokazuje, da so medicinski vsadki majhnih moči in pripadajoče periferne naprave, ki se uporabljajo v komunikacijski storitvi medicinskih vsadkov (MICS), »... sestavljeni tako, da učinkovito uporabljajo in tudi podpirajo učinkovito uporabo radijskega spektra, tako da ne pride do škodljivega motenja« (člen 3.2 Direktive 2014/53/EU) [i.2]. Ne vključuje nujno vseh karakteristik, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno najboljšega možnega delovanja.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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/EU33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 301 839 V2.1.1 (2016-04)SIST EN 301 839 V2.1.1:2016en01-julij-2016SIST EN 301 839 V2.1.1:2016SLOVENSKI
STANDARD
SIST EN 301 839 V2.1.1:2016
ETSI EN 301 839 V2.1.1 (2016-04) 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
HARMONISED EUROPEAN STANDARD SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 2
Reference REN/ERM-TG30-306 Keywords radio, regulation 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.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM 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. SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Modal verbs terminology . 6 Introduction . 7 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 11 3.3 Abbreviations . 12 4 Technical requirements specifications . 12 4.1 Environmental profile . 12 4.2 Conformance requirements . 12 4.2.1 Transmitter requirements . 12 4.2.1.1 Frequency error . 12 4.2.1.1.1 Definition. 12 4.2.1.1.2 Limits . 12 4.2.1.1.3 Conformance . 13 4.2.1.2 Emission bandwidth . 13 4.2.1.2.1 Definition. 13 4.2.1.2.2 Limits . 13 4.2.1.2.3 Conformance . 13 4.2.1.3 Effective radiated power of the fundamental emission . 13 4.2.1.3.1 Definition. 13 4.2.1.3.2 Limits . 13 4.2.1.3.3 Conformance . 13 4.2.1.4 Spurious emissions of transmitter . 14 4.2.1.4.1 Definition. 14 4.2.1.4.2 Limits . 14 4.2.1.4.3 Conformance . 14 4.2.1.5 Frequency stability under low voltage conditions . 14 4.2.1.5.1 Definition. 14 4.2.1.5.2 Limits . 14 4.2.1.5.3 Conformance . 14 4.2.2 Receiver requirements . 14 4.2.2.1 Spurious radiation of receivers . 14 4.2.2.1.1 Definition. 14 4.2.2.1.2 Limits . 14 4.2.2.1.3 Conformance . 15 4.2.3 Transmitter and Receiver requirements . 15 4.2.3.1 Spectrum Access . 15 4.2.3.1.0 General requirements . 15 4.2.3.1.1 LBT/AFA spectrum access . 15 4.2.3.1.2 LP/LDC spectrum access. 15 4.2.3.2 Receiver blocking . 16 4.2.3.2.1 Definition. 16 4.2.3.2.2 Limits . 16 4.2.3.2.3 Conformance . 16 4.3 Mechanical and electrical design . 16 4.3.1 General . 16 4.3.2 Antennas . 16 4.3.3 Controls . 17 SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 4 4.3.4 Transmitter shut-off facility . 17 5 Testing for compliance with technical requirements . 17 5.1 Environmental conditions for testing . 17 5.1.0 General provisions . 17 5.1.1 Presentation of equipment for testing purposes . 17 5.1.1.0
General provisions . 17 5.1.1.1 Choice of model for testing . 17 5.1.1.2 Testing of equipment with alternative power levels . 17 5.1.1.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 18 5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 18 5.1.1.3.2 Equipment with a temporary antenna connector . 18 5.1.1.3.3 Equipment intended to be implanted in a human body . 18 5.1.2 Declarations by the Applicant . 18 5.1.3 Auxiliary test equipment . 18 5.1.4 Test Conditions . 18 5.1.4.1 Normal and extreme test conditions . 18 5.1.4.2 Test power source . 18 5.1.4.2.0 General provisions . 18 5.1.4.2.1 External test power source . 19 5.1.4.2.2 Internal test power source . 19 5.1.4.3 Normal test conditions . 19 5.1.4.3.1 Normal temperature and humidity . 19 5.1.4.3.2 Normal test power source . 19 5.1.4.4 Extreme test conditions . 20 5.1.4.4.1 Extreme temperatures . 20 5.1.4.4.2 Extreme test source voltages . 21 5.1.4.5 Normal test signals and test modulation. 22 5.1.4.5.0 General provisions . 22 5.1.4.5.1 Normal modulation test signals for data . 22 5.1.4.6 Antennas . 22 5.1.4.6.0 General provisions . 22 5.1.4.6.1 Artificial antenna . 22 5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 22 5.1.4.7 Test fixture for ULP-AMI-P . 22 5.1.4.8 Test fixture for ULP-AMI . 23 5.1.4.9 Test sites and general arrangements for radiated measurements . 23 5.1.4.10 Modes of operation of the transmitter . 23 5.1.4.11 Measuring receiver . 23 5.2 Interpretation of the measurement results . 24 5.3 Methods of measurement . 25 5.3.1 Frequency error . 25 5.3.1.0 General provisions . 25 5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 25 5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 25 5.3.2 Emission bandwidth . 26 5.3.3 Effective radiated power of the fundamental emission . 26 5.3.4 Spurious emissions of transmitter . 27 5.3.5 Frequency stability under low voltage conditions . 29 5.3.6 Spurious radiation of receivers . 29 5.3.7 Spectrum Access . 30 5.3.7.1 LBT/AFA spectrum access . 30 5.3.7.1.0 General provisions . 30 5.3.7.1.1 Purpose . 30 5.3.7.1.2 General Remarks on the Measurement Configuration . 31 5.3.7.1.3 LBT threshold power level . 31 5.3.7.1.4 Monitoring system bandwidth . 32 5.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 34 5.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 35 5.3.7.1.7 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs. 36 SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 5 5.3.7.1.8 Use of pre-scanned alternative channel . 36 5.3.8 Receiver blocking . 39 5.3.8.0 General remarks . 39 5.3.8.1 Measurement method using out-of-operating-region disturbance . 39 5.3.8.2 Measurement method using frequency administration commands . 40 5.3.8.3 Results based on the above test method . 40 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 41 Annex B (normative): Radiated measurements . 42 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 42 B.1.1 Outdoor test site . 42 B.1.1.0 Introduction. 42 B.1.1.1 Standard position . 42 B.1.1.2 Equipment in close proximity to the human body but external to it . 43 B.1.1.3 Human torso simulator for ULP-AMI . 43 B.1.2 Test antenna . 44 B.1.3 Substitution antenna . 44 B.1.4 Optional additional indoor site . 45 B.2 Guidance on the use of radiation test sites . 46 B.2.0 Introduction . 46 B.2.1 Measuring distance . 46 B.2.2 Test antenna . 46 B.2.3 Substitution antenna . 46 B.2.4 Artificial antenna . 46 B.2.5 Auxiliary cables . 46 B.3 Further optional alternative indoor test site using an anechoic chamber . 47 B.3.0 Introduction . 47 B.3.1 Example of the construction of a shielded anechoic chamber . 47 B.3.2 Influence of parasitic reflections in anechoic chambers . 47 B.3.3 Calibration of the shielded RF anechoic chamber . 48 Annex C (normative): Technical performance of the spectrum analyser . 50 Annex D (informative): Bibliography . 51 History . 52
SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 6 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.9] 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.2]. 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.
National transposition dates Date of adoption of this EN: 25 April 2016 Date of latest announcement of this EN (doa): 31 July 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 January 2017 Date of withdrawal of any conflicting National Standard (dow): 31 January 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. SIST EN 301 839 V2.1.1:2016
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 7 Introduction ULP-AMI/ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical field, that provides 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 MICS service consists of active medical implants that communicate to other active medical implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters. The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-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. 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. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter, receiver and spectrum access.
Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and inte
...
ETSI EN 301 839 V2.1.1 (2016-04)
HARMONISED EUROPEAN STANDARD
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
---------------------- Page: 1 ----------------------
2 ETSI EN 301 839 V2.1.1 (2016-04)
Reference
REN/ERM-TG30-306
Keywords
radio, regulation
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 301 839 V2.1.1 (2016-04)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 7
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Technical requirements specifications . 12
4.1 Environmental profile . 12
4.2 Conformance requirements . 12
4.2.1 Transmitter requirements . 12
4.2.1.1 Frequency error . 12
4.2.1.1.1 Definition. 12
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 13
4.2.1.2 Emission bandwidth . 13
4.2.1.2.1 Definition. 13
4.2.1.2.2 Limits . 13
4.2.1.2.3 Conformance . 13
4.2.1.3 Effective radiated power of the fundamental emission . 13
4.2.1.3.1 Definition. 13
4.2.1.3.2 Limits . 13
4.2.1.3.3 Conformance . 13
4.2.1.4 Spurious emissions of transmitter . 14
4.2.1.4.1 Definition. 14
4.2.1.4.2 Limits . 14
4.2.1.4.3 Conformance . 14
4.2.1.5 Frequency stability under low voltage conditions . 14
4.2.1.5.1 Definition. 14
4.2.1.5.2 Limits . 14
4.2.1.5.3 Conformance . 14
4.2.2 Receiver requirements . 14
4.2.2.1 Spurious radiation of receivers . 14
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 15
4.2.3 Transmitter and Receiver requirements . 15
4.2.3.1 Spectrum Access . 15
4.2.3.1.0 General requirements . 15
4.2.3.1.1 LBT/AFA spectrum access . 15
4.2.3.1.2 LP/LDC spectrum access. 15
4.2.3.2 Receiver blocking . 16
4.2.3.2.1 Definition. 16
4.2.3.2.2 Limits . 16
4.2.3.2.3 Conformance . 16
4.3 Mechanical and electrical design . 16
4.3.1 General . 16
4.3.2 Antennas . 16
4.3.3 Controls . 17
ETSI
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4 ETSI EN 301 839 V2.1.1 (2016-04)
4.3.4 Transmitter shut-off facility . 17
5 Testing for compliance with technical requirements . 17
5.1 Environmental conditions for testing . 17
5.1.0 General provisions . 17
5.1.1 Presentation of equipment for testing purposes . 17
5.1.1.0 General provisions . 17
5.1.1.1 Choice of model for testing . 17
5.1.1.2 Testing of equipment with alternative power levels . 17
5.1.1.3 Presentation of equipment that does not have an external RF connector (integral antenna
equipment) . 18
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 18
5.1.1.3.2 Equipment with a temporary antenna connector . 18
5.1.1.3.3 Equipment intended to be implanted in a human body . 18
5.1.2 Declarations by the Applicant . 18
5.1.3 Auxiliary test equipment . 18
5.1.4 Test Conditions . 18
5.1.4.1 Normal and extreme test conditions . 18
5.1.4.2 Test power source . 18
5.1.4.2.0 General provisions . 18
5.1.4.2.1 External test power source . 19
5.1.4.2.2 Internal test power source . 19
5.1.4.3 Normal test conditions . 19
5.1.4.3.1 Normal temperature and humidity . 19
5.1.4.3.2 Normal test power source . 19
5.1.4.4 Extreme test conditions . 20
5.1.4.4.1 Extreme temperatures . 20
5.1.4.4.2 Extreme test source voltages . 21
5.1.4.5 Normal test signals and test modulation. 22
5.1.4.5.0 General provisions . 22
5.1.4.5.1 Normal modulation test signals for data . 22
5.1.4.6 Antennas . 22
5.1.4.6.0 General provisions . 22
5.1.4.6.1 Artificial antenna . 22
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 22
5.1.4.7 Test fixture for ULP-AMI-P . 22
5.1.4.8 Test fixture for ULP-AMI . 23
5.1.4.9 Test sites and general arrangements for radiated measurements . 23
5.1.4.10 Modes of operation of the transmitter . 23
5.1.4.11 Measuring receiver . 23
5.2 Interpretation of the measurement results . 24
5.3 Methods of measurement . 25
5.3.1 Frequency error . 25
5.3.1.0 General provisions . 25
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 25
5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 25
5.3.2 Emission bandwidth . 26
5.3.3 Effective radiated power of the fundamental emission . 26
5.3.4 Spurious emissions of transmitter . 27
5.3.5 Frequency stability under low voltage conditions . 29
5.3.6 Spurious radiation of receivers . 29
5.3.7 Spectrum Access . 30
5.3.7.1 LBT/AFA spectrum access . 30
5.3.7.1.0 General provisions . 30
5.3.7.1.1 Purpose . 30
5.3.7.1.2 General Remarks on the Measurement Configuration . 31
5.3.7.1.3 LBT threshold power level . 31
5.3.7.1.4 Monitoring system bandwidth . 32
5.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 34
5.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level,
P . 35
Th
5.3.7.1.7 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs. 36
ETSI
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5 ETSI EN 301 839 V2.1.1 (2016-04)
5.3.7.1.8 Use of pre-scanned alternative channel . 36
5.3.8 Receiver blocking . 39
5.3.8.0 General remarks . 39
5.3.8.1 Measurement method using out-of-operating-region disturbance . 39
5.3.8.2 Measurement method using frequency administration commands . 40
5.3.8.3 Results based on the above test method . 40
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 41
Annex B (normative): Radiated measurements . 42
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 42
B.1.1 Outdoor test site . 42
B.1.1.0 Introduction. 42
B.1.1.1 Standard position . 42
B.1.1.2 Equipment in close proximity to the human body but external to it . 43
B.1.1.3 Human torso simulator for ULP-AMI . 43
B.1.2 Test antenna . 44
B.1.3 Substitution antenna . 44
B.1.4 Optional additional indoor site . 45
B.2 Guidance on the use of radiation test sites . 46
B.2.0 Introduction . 46
B.2.1 Measuring distance . 46
B.2.2 Test antenna . 46
B.2.3 Substitution antenna . 46
B.2.4 Artificial antenna . 46
B.2.5 Auxiliary cables . 46
B.3 Further optional alternative indoor test site using an anechoic chamber . 47
B.3.0 Introduction . 47
B.3.1 Example of the construction of a shielded anechoic chamber . 47
B.3.2 Influence of parasitic reflections in anechoic chambers . 47
B.3.3 Calibration of the shielded RF anechoic chamber . 48
Annex C (normative): Technical performance of the spectrum analyser . 50
Annex D (informative): Bibliography . 51
History . 52
ETSI
---------------------- Page: 5 ----------------------
6 ETSI EN 301 839 V2.1.1 (2016-04)
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.9] 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.2].
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.
National transposition dates
Date of adoption of this EN: 25 April 2016
Date of latest announcement of this EN (doa): 31 July 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 January 2017
Date of withdrawal of any conflicting National Standard (dow): 31 January 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
---------------------- Page: 6 ----------------------
7 ETSI EN 301 839 V2.1.1 (2016-04)
Introduction
ULP-AMI/ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical
field, that provides 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 MICS service consists of active medical implants that communicate to other active medical
implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters.
The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-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.
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.
Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the
definitions, symbols and abbreviations used.
Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter, receiver and
spectrum access.
Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement results
with the maximum measurement uncertainty values.
Clause 5.3.7 specifies the required measurement methods. In particular clause 5.3.7.1 describes the monitoring system
performance specifications that have been chosen to mini
...
Draft ETSI EN 301 839 V2.1.0 (2015-07)
HARMONISED EUROPEAN STANDARD
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
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 301 839 V2.1.0 (2015-07)
Reference
REN/ERM-TG30-306
Keywords
radio, regulation
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GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
---------------------- Page: 2 ----------------------
3 Draft ETSI EN 301 839 V2.1.0 (2015-07)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Technical requirements specifications . 12
4.1 Environmental profile . 12
4.2 Conformance requirements . 12
4.2.1 Transmitter requirements . 12
4.2.1.1 Frequency error . 12
4.2.1.1.1 Definition. 12
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.1.2 Emission bandwidth . 13
4.2.1.2.1 Definition. 13
4.2.1.2.2 Limits . 13
4.2.1.2.3 Conformance . 13
4.2.1.3 Effective radiated power of the fundamental emission . 13
4.2.1.3.1 Definition. 13
4.2.1.3.2 Limits . 13
4.2.1.3.3 Conformance . 13
4.2.1.4 Spurious emissions of transmitter . 13
4.2.1.4.1 Definition. 13
4.2.1.4.2 Limits . 14
4.2.1.4.3 Conformance . 14
4.2.1.5 Frequency stability under low voltage conditions . 14
4.2.1.5.1 Definition. 14
4.2.1.5.2 Limits . 14
4.2.1.5.3 Conformance . 14
4.2.2 Receiver requirements . 14
4.2.2.1 Spurious radiation of receivers . 14
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 14
4.2.3 Transmitter and Receiver requirements . 15
4.2.3.1 Spectrum Access . 15
4.2.3.1.0 General requirements . 15
4.2.3.1.1 LBT/AFA spectrum access . 15
4.2.3.1.2 LP/LDC spectrum access. 15
4.3 Mechanical and electrical design . 16
4.3.1 General . 16
4.3.2 Antennas . 16
4.3.3 Controls . 16
4.3.4 Transmitter shut-off facility . 16
5 Testing for compliance with technical requirements . 17
5.1 Environmental conditions for testing . 17
5.1.0 General provisions . 17
ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 301 839 V2.1.0 (2015-07)
5.1.1 Presentation of equipment for testing purposes . 17
5.1.1.0 General provisions . 17
5.1.1.1 Choice of model for testing . 17
5.1.1.2 Testing of equipment with alternative power levels . 17
5.1.1.3 Presentation of equipment that does not have an external RF connector (integral antenna
equipment) . 17
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 17
5.1.1.3.2 Equipment with a temporary antenna connector . 18
5.1.1.3.3 Equipment intended to be implanted in a human body . 18
5.1.2 Declarations by the Applicant . 18
5.1.3 Auxiliary test equipment . 18
5.1.4 Test Conditions . 18
5.1.4.1 Normal and extreme test conditions . 18
5.1.4.2 Test power source . 18
5.1.4.2.0 General provisions . 18
5.1.4.2.1 External test power source . 18
5.1.4.2.2 Internal test power source . 19
5.1.4.3 Normal test conditions . 19
5.1.4.3.1 Normal temperature and humidity . 19
5.1.4.3.2 Normal test power source . 19
5.1.4.4 Extreme test conditions . 20
5.1.4.4.1 Extreme temperatures . 20
5.1.4.4.2 Extreme test source voltages . 21
5.1.4.5 Normal test signals and test modulation. 22
5.1.4.5.0 General provisions . 22
5.1.4.5.1 Normal modulation test signals for data . 22
5.1.4.6 Antennas . 22
5.1.4.6.0 General provisions . 22
5.1.4.6.1 Artificial antenna . 22
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 22
5.1.4.7 Test fixture for ULP-AMI-P . 22
5.1.4.8 Test fixture for ULP-AMI . 23
5.1.4.9 Test sites and general arrangements for radiated measurements . 23
5.1.4.10 Modes of operation of the transmitter . 23
5.1.4.11 Measuring receiver . 23
5.2 Interpretation of the measurement results . 24
5.3 Methods of measurement . 25
5.3.1 Frequency error . 25
5.3.1.0 General provisions . 25
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 25
5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 25
5.3.2 Emission bandwidth . 25
5.3.3 Effective radiated power of the fundamental emission . 26
5.3.4 Spurious emissions of transmitter . 27
5.3.5 Frequency stability under low voltage conditions . 28
5.3.6 Spurious radiation of receivers . 28
5.3.7 Spectrum Access . 30
5.3.7.1 LBT/AFA spectrum access . 30
5.3.7.1.0 General provisions . 30
5.3.7.1.1 Purpose . 30
5.3.7.1.2 General Remarks on the Measurement Configuration . 30
5.3.7.1.3 LBT threshold power level . 31
5.3.7.1.4 Monitoring system bandwidth . 32
5.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 33
5.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level,
P . 35
Th
5.3.7.1.7 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs. 36
5.3.7.1.8 Use of pre-scanned alternative channel . 36
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 39
ETSI
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 301 839 V2.1.0 (2015-07)
Annex B (normative): Radiated measurements . 40
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 40
B.1.1 Outdoor test site . 40
B.1.1.0 Introduction. 40
B.1.1.1 Standard position . 40
B.1.1.2 Equipment in close proximity to the human body but external to it . 41
B.1.1.3 Human torso simulator for ULP-AMI . 41
B.1.2 Test antenna . 42
B.1.3 Substitution antenna . 42
B.1.4 Optional additional indoor site . 43
B.2 Guidance on the use of radiation test sites . 44
B.2.0 Introduction . 44
B.2.1 Measuring distance . 44
B.2.2 Test antenna . 44
B.2.3 Substitution antenna . 44
B.2.4 Artificial antenna . 44
B.2.5 Auxiliary cables . 44
B.3 Further optional alternative indoor test site using an anechoic chamber . 45
B.3.0 Introduction . 45
B.3.1 Example of the construction of a shielded anechoic chamber . 45
B.3.2 Influence of parasitic reflections in anechoic chambers . 45
B.3.3 Calibration of the shielded RF anechoic chamber . 46
Annex C (normative): Technical performance of the spectrum analyser . 48
Annex D (informative): Bibliography . 49
History . 50
ETSI
---------------------- Page: 5 ----------------------
6 Draft ETSI EN 301 839 V2.1.0 (2015-07)
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 (http://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 draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote
phase of the ETSI standards EN Approval Procedure.
The present document has been prepared to provide a means of conforming to the essential requirements of
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].
NOTE: The corresponding Commission's standardization request is expected shortly.
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.
Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa
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.
Introduction
ULP-AMI/ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical
field, that provides 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 MICS service consists of active medical implants that communicate to other active medical
implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters.
ETSI
---------------------- Page: 6 ----------------------
7 Draft ETSI EN 301 839 V2.1.0 (2015-07)
The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-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.
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.
Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the
definitions, symbols and abbreviations used.
Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter, receiver and
spectrum access.
Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement results
with the maximum measurement uncertainty values.
Clause 5.3.7 specifies the required measurement methods. In particular clause 5.3.7.1 describes the monitoring system
performance specifications that have been chosen to minimize harmful interference to other equipment or services and
minimize the potential for disturbance to this equipment from ambient sources or other medical device users in the
band.
Annex A (normative) provides the relationship between the present document and the essential requirements of
Directive 2014/53/EU [i.2].
Annex B (normative) provides specifications concerning radiated measurements.
Annex C (normative) provides technical performance of the spectrum analyser.
Annex D (informative) bibliography; provides additional information.
ETSI
---------------------- Page: 7 ----------------------
8 Draft ETSI EN 301 839 V2.1.0 (2015-07)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI).
• Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands in table 1.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) oper
...
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