SIST EN 302 195 V2.1.1:2016
(Main)Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - 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 accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any
associated Peripherals (ULP-AMI-P) transmitters and receivers operating in the frequency range of 9 kHz to 315 kHz
including external programmers and patient related telecommunication devices using digital modulation techniques
such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the
present document.
The present document applies to ULP-AMI/ULP/AMI-P transmitters and receivers:
• transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m;
• receivers operating in the range from 9 kHz to 315 kHz.
The present document applies to ULP-AMI devices:
• either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna;
• for telecommand, telemetry etc. applications;
• for all types of digital modulation.
The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient
programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the
implanted patient).
The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio
equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "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 pribor (ULP-AMI-P) ), ki delujejo v frekvenčnem območju 9 kHz do 315 kHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU
Ta dokument se uporablja za oddajnike in sprejemnike aktivnih medicinskih vsadkov ultra majhnih moči, ki delujejo v frekvenčnem območju od 9 do 315 kHz, ter pripadajočih perifernih naprav (ULP-AMI-P), ki delujejo v frekvenčnem območju od 9 do 315 kHz, vključno z napravami za programiranje in telekomunikacijskimi napravami za bolnike, ki uporabljajo tehnike digitalne modulacije, kot so frekvenčno premično kodiranje ali pulzna pozicijska modulacija, vendar ne omejeno nanje. Analogna modulacija glasu ne spada na področje uporabe tega dokumenta.
Ta dokument se uporablja za oddajnike in sprejemnike aktivnih medicinskih vsadkov ultra majhnih moči ter pripadajočih perifernih naprav:
• Oddajniki, ki delujejo v območju od 9 do 315 kHz z ravnmi zvočne moči do 30 dBuA/m pri 10 m.
• Sprejemniki, ki delujejo v območju od 9 do 315 kHz.
Ta dokument se uporablja za medicinske vsadke majhnih moči:
• radiofrekvenčno (RF) izhodno povezavo in ustrezno anteno ali z vgrajeno anteno;
• za daljinsko vodenje, telemetrijo in podobne uporabe;
• za vse vrste digitalne modulacije.
Ta dokument zajema pritrjene (naprave za programiranje/krmilniki za zdravnike), mobilne (ročne ali druge naprave za programiranje za bolnike) in prenosne postaje (vsajene naprave, ki bolniku zagotavljajo medicinsko korist) perifernih naprav aktivnih medicinskih vsadkov ultra majhnih moči.
Ta dokument vsebuje tehnične zahteve za lastnosti radijske opreme aktivnih medicinskih vsadkov ultra majhnih moči ter pripadajočih perifernih naprav, ki so skladne s poddelom (a) dodatka 12 priporočila CEPT/ERC 70-03 [i.1]. Ta dokument vsebuje tehnične zahteve, s katerimi se dokazuje, da so aktivni medicinski vsadki ultra majhnih moči (ULP-AMI) ter pripadajoče periferne naprave (ULP-AMI-P), ki delujejo v frekvenčnem območju od 9 do 315 kHz izdelani tako, da optimalno uporabljajo in podpirajo učinkovito izrabo radijskega spektra, z namenom preprečevanja škodljivega motenja, skladno s členom 3.2 Direktive 2014/53/EU) [i.2]. Ne vključuje nujno vseh značilnosti, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno najboljšega možnega delovanja.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 302 195 V2.1.1 (2016-06)SIST EN 302 195 V2.1.1:2016en01-september-2016SIST EN 302 195 V2.1.1:2016SLOVENSKI
STANDARD
SIST EN 302 195 V2.1.1:2016
ETSI EN 302 195 V2.1.1 (2016-06) Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
HARMONISED EUROPEAN STANDARD SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 2
Reference REN/ERM-TG30-310 Keywords health, inductive, magnetic, mobile, radio, regulation, short range, 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.
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 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 3 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 . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 10 3.3 Abbreviations . 10 4 Technical requirements specifications . 11 4.1 Environmental profile . 11 4.2 Transmitter requirements . 11 4.2.1 Radiated field strength . 11 4.2.1.0 General . 11 4.2.1.1 Radiated H-field . 11 4.2.1.1.0 General . 11 4.2.1.1.1 Definition. 11 4.2.1.1.2 Limits . 12 4.2.1.1.3 Conformance . 12 4.2.2 Permitted range of modulation bandwidth . 12 4.2.2.0 General . 12 4.2.2.1 Definition . 12 4.2.2.2 Limits . 12 4.2.2.3 Conformance . 13 4.2.3 Spurious emissions . 13 4.2.3.0 General . 13 4.2.3.1 Definition . 13 4.2.3.2 Limits . 13 4.2.3.3 Conformance . 13 4.2.4 Duty cycle . 13 4.2.4.0 General . 13 4.2.4.1 Definitions . 13 4.2.4.2 Limits . 13 4.2.4.3 Conformance . 13 4.3 Receiver requirements . 14 4.3.1 Receiver Classification . 14 4.3.2 Blocking . 14 4.3.2.0 General . 14 4.3.2.1 Definition . 14 4.3.2.2 Limits . 14 4.3.2.3 Conformance . 15 4.3.3 Receiver spurious radiations . 15 4.3.3.0 General . 15 4.3.3.1 Definition . 15 4.3.3.2 Limits . 15 4.3.3.3 Conformance . 15 5 Testing for compliance with technical requirements . 15 5.1 Environmental conditions for testing . 15 5.1.0 General remarks . 15 5.1.1 Presentation of equipment for testing purposes . 16 SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 4 5.1.2 Choice of model for testing . 16 5.1.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna equipment) . 16 5.1.3.0 General remarks . 16 5.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16 5.1.3.2 Equipment with a temporary antenna connector . 16 5.1.4 Controls . 17 5.1.5 Transmitter shut-off facility . 17 5.1.6 Receiver power save capability . 17 5.1.7 Equipment intended to be implanted in a human body . 17 5.1.8 Declarations by the Applicant . 17 5.1.9 Auxiliary test equipment . 17 5.1.10 Test conditions . 17 5.1.10.1 Normal and extreme test-conditions. 17 5.1.10.2 Test power source . 17 5.1.10.2.0 General remarks. 17 5.1.10.2.1 External test power source . 18 5.1.10.2.2 Internal test power source . 18 5.1.10.3 Normal test Condition . 18 5.1.10.3.1 Normal temperature and humidity . 18 5.1.10.3.2 Normal test power source . 18 5.1.10.4 Extreme test conditions . 19 5.1.10.4.1 Extreme temperatures . 19 5.1.10.4.2 Extreme test source voltages . 20 5.1.10.5 Normal test signals and test modulation. 21 5.1.10.5.0 General remarks. 21 5.1.10.5.1 Normal modulation test signals for data . 21 5.1.10.6 Antenna . 21 5.1.10.6.0 General remarks. 21 5.1.10.6.1 Artificial Antenna . 21 5.1.10.7 Test fixture . 22 5.1.10.7.0 General remarks. 22 5.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a human body . 22 5.1.10.8 Test sites and general arrangements for radiated measurements . 22 5.1.10.9 Modes of operation of the transmitter . 22 5.1.10.10 Measuring receiver . 23 5.2 Interpretation of the measurement results . 23 5.3 Method of Measurements . 23 5.3.1 Radiated field strength . 23 5.3.1.0 General remarks . 23 5.3.1.1 Radiated Field Strength (H-field) . 24 5.3.2 Permitted frequency range of the modulation bandwidth . 24 5.3.3 Spurious emissions . 25 5.3.4 Receiver requirement . 25 5.3.4.1 Blocking . 25 5.3.4.2 Receiver spurious radiation . 26 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 27 Annex B (normative): Radiated measurements . 28 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 28 B.1.1 Outdoor test site . 28 B.1.1.0 General remarks . 28 B.1.1.1 Standard position . 28 B.1.1.2 Equipment in close proximity to the human body but external to it . 29 B.1.1.3 Active medical implant equipment . 29 B.1.2 Test antenna . 31 B.1.2.1 Below 30 MHz . 31 B.1.3 Optional additional indoor site . 31 B.2 Guidance on the use of radiation test sites . 31 SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 5 B.2.0 General remarks . 31 B.2.1 Measuring distance . 32 B.2.2 Auxiliary cables . 32 Annex C (normative): H-field measurements at other distances than 10 m . 33 Annex D (informative): Bibliography . 35 History . 36
SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 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.6] 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: 14 June 2016 Date of latest announcement of this EN (doa): 30 September 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2017 Date of withdrawal of any conflicting National Standard (dow): 31 March 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. Introduction The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate in the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link. The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral antenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristics being measured are representative of the final product placed on the market. SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 7 If equipment already placed on the market is required to be inspected 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 and receiver function. 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 specifies the required measurement methods. 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 procedures for H-field measurements at other distances than 10 m. Annex D (informative) bibliography; provides additional information.
SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 8 1 Scope The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any associated Peripherals (ULP-AMI-P) transmitters and receivers operating in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the present document. The present document applies to ULP-AMI/ULP/AMI-P transmitters and receivers: • transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m; • receivers operating in the range from 9 kHz to 315 kHz. The present document applies to ULP-AMI devices: • either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna; • for telecommand, telemetry etc. applications; • for all types of digital modulation. The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient). The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1]. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "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. 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. Not applicable. SIST EN 302 195 V2.1.1:2016
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 9 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] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)". [i.2] 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 Dire
...
ETSI EN 302 195 V2.1.1 (2016-06)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and accessories (ULP-AMI-P) operating in the
frequency range 9 kHz to 315 kHz
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 ETSI EN 302 195 V2.1.1 (2016-06)
Reference
REN/ERM-TG30-310
Keywords
health, inductive, magnetic, mobile, radio,
regulation, short range, 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 302 195 V2.1.1 (2016-06)
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 . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 10
3.3 Abbreviations . 10
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Transmitter requirements . 11
4.2.1 Radiated field strength . 11
4.2.1.0 General . 11
4.2.1.1 Radiated H-field . 11
4.2.1.1.0 General . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.2 Permitted range of modulation bandwidth . 12
4.2.2.0 General . 12
4.2.2.1 Definition . 12
4.2.2.2 Limits . 12
4.2.2.3 Conformance . 13
4.2.3 Spurious emissions . 13
4.2.3.0 General . 13
4.2.3.1 Definition . 13
4.2.3.2 Limits . 13
4.2.3.3 Conformance . 13
4.2.4 Duty cycle . 13
4.2.4.0 General . 13
4.2.4.1 Definitions . 13
4.2.4.2 Limits . 13
4.2.4.3 Conformance . 13
4.3 Receiver requirements . 14
4.3.1 Receiver Classification . 14
4.3.2 Blocking . 14
4.3.2.0 General . 14
4.3.2.1 Definition . 14
4.3.2.2 Limits . 14
4.3.2.3 Conformance . 15
4.3.3 Receiver spurious radiations . 15
4.3.3.0 General . 15
4.3.3.1 Definition . 15
4.3.3.2 Limits . 15
4.3.3.3 Conformance . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General remarks . 15
5.1.1 Presentation of equipment for testing purposes . 16
ETSI
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4 ETSI EN 302 195 V2.1.1 (2016-06)
5.1.2 Choice of model for testing . 16
5.1.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 16
5.1.3.0 General remarks . 16
5.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.3.2 Equipment with a temporary antenna connector . 16
5.1.4 Controls . 17
5.1.5 Transmitter shut-off facility . 17
5.1.6 Receiver power save capability . 17
5.1.7 Equipment intended to be implanted in a human body . 17
5.1.8 Declarations by the Applicant . 17
5.1.9 Auxiliary test equipment . 17
5.1.10 Test conditions . 17
5.1.10.1 Normal and extreme test-conditions. 17
5.1.10.2 Test power source . 17
5.1.10.2.0 General remarks. 17
5.1.10.2.1 External test power source . 18
5.1.10.2.2 Internal test power source . 18
5.1.10.3 Normal test Condition . 18
5.1.10.3.1 Normal temperature and humidity . 18
5.1.10.3.2 Normal test power source . 18
5.1.10.4 Extreme test conditions . 19
5.1.10.4.1 Extreme temperatures . 19
5.1.10.4.2 Extreme test source voltages . 20
5.1.10.5 Normal test signals and test modulation. 21
5.1.10.5.0 General remarks. 21
5.1.10.5.1 Normal modulation test signals for data . 21
5.1.10.6 Antenna . 21
5.1.10.6.0 General remarks. 21
5.1.10.6.1 Artificial Antenna . 21
5.1.10.7 Test fixture . 22
5.1.10.7.0 General remarks. 22
5.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a human body . 22
5.1.10.8 Test sites and general arrangements for radiated measurements . 22
5.1.10.9 Modes of operation of the transmitter . 22
5.1.10.10 Measuring receiver . 23
5.2 Interpretation of the measurement results . 23
5.3 Method of Measurements . 23
5.3.1 Radiated field strength . 23
5.3.1.0 General remarks . 23
5.3.1.1 Radiated Field Strength (H-field) . 24
5.3.2 Permitted frequency range of the modulation bandwidth . 24
5.3.3 Spurious emissions . 25
5.3.4 Receiver requirement . 25
5.3.4.1 Blocking . 25
5.3.4.2 Receiver spurious radiation . 26
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 27
Annex B (normative): Radiated measurements . 28
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 28
B.1.1 Outdoor test site . 28
B.1.1.0 General remarks . 28
B.1.1.1 Standard position . 28
B.1.1.2 Equipment in close proximity to the human body but external to it . 29
B.1.1.3 Active medical implant equipment . 29
B.1.2 Test antenna . 31
B.1.2.1 Below 30 MHz . 31
B.1.3 Optional additional indoor site . 31
B.2 Guidance on the use of radiation test sites . 31
ETSI
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5 ETSI EN 302 195 V2.1.1 (2016-06)
B.2.0 General remarks . 31
B.2.1 Measuring distance . 32
B.2.2 Auxiliary cables . 32
Annex C (normative): H-field measurements at other distances than 10 m . 33
Annex D (informative): Bibliography . 35
History . 36
ETSI
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6 ETSI EN 302 195 V2.1.1 (2016-06)
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.6] 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: 14 June 2016
Date of latest announcement of this EN (doa): 30 September 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 March 2017
Date of withdrawal of any conflicting National Standard (dow): 31 March 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.
Introduction
The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-
implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate
in the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link.
The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating
attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral
antenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristics
being measured are representative of the final product placed on the market.
ETSI
---------------------- Page: 6 ----------------------
7 ETSI EN 302 195 V2.1.1 (2016-06)
If equipment already placed on the market is required to be inspected 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 and receiver
function.
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 specifies the required measurement methods.
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 procedures for H-field measurements at other distances than 10 m.
Annex D (informative) bibliography; provides additional information.
ETSI
---------------------- Page: 7 ----------------------
8 ETSI EN 302 195 V2.1.1 (2016-06)
1 Scope
The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any
associated Peripherals (ULP-AMI-P) transmitters and receivers operating in the frequency range of 9 kHz to 315 kHz
including external programmers and patient related telecommunication devices using digital modulation techniques
such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the
present document.
The present document applies to ULP-AMI/ULP/AMI-P transmitters and receivers:
• transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m;
• receivers operating in the range from 9 kHz to 315 kHz.
The present document applies to ULP-AMI devices:
• either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna;
• for telecommand, telemetry etc. applications;
• for all types of digital modulation.
The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient
programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the
implanted patient).
The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio
equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "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.
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.
Not applicable.
ETSI
---------------------- Page: 8 ----------------------
9 ETSI EN 302 195 V2.1.1 (2016-06)
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] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.2] 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.3] ETSI TR 100 028 (all parts) (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters
(ERM); Uncertainties in the measurement of mobile radio equipment chara
...
Draft ETSI EN 302 195 V2.0.1 (2016-03)
HARMONISED EUROPEAN STANDARD
Ultra Low Power Active Medical Implants (ULP-AMI)
and accessories (ULP-AMI-P) operating in the
frequency range 9 kHz to 315 kHz
Harmonised Standard covering the essential requirements of
article 3.2 of the Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 302 195 V2.0.1 (2016-03)
Reference
REN/ERM-TG30-310
Keywords
health, inductive, magnetic, mobile, radio,
regulation, short range, SRD, testing
ETSI
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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 302 195 V2.0.1 (2016-03)
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 . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 10
3.3 Abbreviations . 10
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Transmitter requirements . 11
4.2.1 Radiated field strength . 11
4.2.1.0 General . 11
4.2.1.1 Radiated H-field . 11
4.2.1.1.0 General . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.2 Permitted range of modulation bandwidth . 12
4.2.2.0 General . 12
4.2.2.1 Definition . 12
4.2.2.2 Limits . 12
4.2.2.3 Conformance . 12
4.2.3 Spurious emissions . 13
4.2.3.0 General remarks . 13
4.2.3.1 Definition . 13
4.2.3.2 Limits . 13
4.2.3.3 Conformance . 13
4.2.4 Duty cycle . 13
4.2.4.0 General . 13
4.2.4.1 Definitions . 13
4.2.4.2 Limits . 13
4.2.4.3 Conformance . 13
4.3 Receiver requirements . 14
4.3.1 Receiver Classification . 14
4.3.2 Blocking . 14
4.3.2.0 General remaraks . 14
4.3.2.1 Definition . 14
4.3.2.2 Limits . 14
4.3.2.3 Conformance . 14
4.3.3 Receiver spurious radiations . 15
4.3.3.0 General . 15
4.3.3.1 Definition . 15
4.3.3.2 Limits . 15
4.3.3.3 Conformance . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General remarks . 15
5.1.1 Presentation of equipment for testing purposes . 15
5.1.2 Choice of model for testing . 16
ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 302 195 V2.0.1 (2016-03)
5.1.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 16
5.1.3.0 General remarks . 16
5.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.3.2 Equipment with a temporary antenna connector . 16
5.1.4 Controls . 16
5.1.5 Transmitter shut-off facility . 16
5.1.6 Receiver power save capability . 16
5.1.7 Equipment intended to be implanted in a human body . 17
5.1.8 Declarations by the Applicant . 17
5.1.9 Auxiliary test equipment . 17
5.1.10 Test conditions . 17
5.1.10.1 Normal and extreme test-conditions. 17
5.1.10.2 Test power source . 17
5.1.10.2.0 General remarks. 17
5.1.10.2.1 External test power source . 17
5.1.10.2.2 Internal test power source . 17
5.1.10.3 Normal test Condition . 18
5.1.10.3.1 Normal temperature and humidity . 18
5.1.10.3.2 Normal test power source . 18
5.1.10.4 Extreme test conditions . 18
5.1.10.4.1 Extreme temperatures . 18
5.1.10.4.2 Extreme test source voltages . 20
5.1.10.5 Normal test signals and test modulation. 20
5.1.10.5.0 General remarks. 20
5.1.10.5.1 Normal modulation test signals for data . 21
5.1.10.6 Antenna . 21
5.1.10.6.0 General remarks. 21
5.1.10.6.1 Artificial Antenna . 21
5.1.10.7 Test fixture . 21
5.1.10.7.0 General remarks. 21
5.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a human body . 22
5.1.10.8 Test sites and general arrangements for radiated measurements . 22
5.1.10.9 Modes of operation of the transmitter . 22
5.1.10.10 Measuring receiver . 22
5.2 Interpretation of the measurement results . 22
5.3 Method of Measurements . 23
5.3.1 Radiated field strength . 23
5.3.1.0 General remarks . 23
5.3.1.1 Radiated Field Strength (H-field) . 23
5.3.2 Permitted frequency range of the modulation bandwidth . 24
5.3.3 Spurious emissions . 24
5.3.4 Receiver requirement . 24
5.3.4.1 Blocking . 24
5.3.4.2 Receiver spurious radiation . 25
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 26
Annex B (normative): Radiated measurements . 27
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 27
B.1.1 Outdoor test site . 27
B.1.1.0 General remarks . 27
B.1.1.1 Standard position . 27
B.1.1.2 Equipment in close proximity to the human body but external to it . 28
B.1.1.3 Active medical implant equipment . 28
B.1.2 Test antenna . 29
B.1.2.1 Below 30 MHz . 29
B.1.3 Optional additional indoor site . 29
B.2 Guidance on the use of radiation test sites . 30
B.2.0 General remarks . 30
ETSI
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 302 195 V2.0.1 (2016-03)
B.2.1 Measuring distance . 30
B.2.2 Auxiliary cables . 30
Annex C (normative): H-field measurements at other distances than 10 m . 31
Annex D (informative): Bibliography . 33
History . 34
ETSI
---------------------- Page: 5 ----------------------
6 Draft ETSI EN 302 195 V2.0.1 (2016-03)
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 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 under the Commission's standardisation request C(2015) 5376 final [i.6] 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.
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
The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-
implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate
in the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link.
The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating
attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral
antenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristics
being measured are representative of the final product placed on the market.
If equipment already placed on the market is required to be inspected it should be tested in accordance with the methods
of measurement specified in the present document.
ETSI
---------------------- Page: 6 ----------------------
7 Draft ETSI EN 302 195 V2.0.1 (2016-03)
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 and receiver
function.
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 specifies the required measurement methods.
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 302 195 V2.0.1 (2016-03)
1 Scope
The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any
associated Peripherals (ULP-AMI-P) transmitters and receivers operating in the frequency range of 9 kHz to 315 kHz
including external programmers and patient related telecommunication devices using digital modulation techniques
such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the
present document.
The present document applies to ULP-AMI/ULP/AMI-P transmitters and receivers:
• transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m;
• receivers operating in the range from 9 kHz to 315 kHz.
The present document applies to ULP-AMI devices:
• either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna;
• for telecommand, telemetry etc. applications;
• for all types of digital modulation.
The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient
programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the
implanted patient).
All types of digital modulation for implanted radio devices and associated accessories are covered by the present
document.
The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio
equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "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.
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.
Not applicable.
ETSI
---------------------- Page: 8 ----------------------
9 Draft ETSI EN 302 195 V2.0.1 (2016-03)
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] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.2] 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 mar
...
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