SIST EN 301 489-35 V2.1.1:2017
(Main)ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU - Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU - Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated with Low Power Active Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral devices (LP-AMI-P).
Technical specifications related to the antenna port and emissions from the enclosure port of the radio system of LP-AMI and associated Peripheral devices (LP-AMI-P) are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for of LP-AMI and associated Peripheral devices (LP-AMI-P).
Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].
Standard elektromagnetne združljivosti (EMC) za radijsko opremo in storitve - Harmonizirani standard, ki zajema bistvene zahteve člena 3.1(b) direktive 2014/53/EU - 35. del: Posebne zahteve za aktivne medicinske vsadke z majhno močjo (LP-AMI), ki delujejo v frekvenčnem pasu od 2483,5 MHz do 2500 MHz
Ta dokument skupaj s standardom ETSI EN 301 489-1 [1] zajema oceno elektromagnetne združljivosti (EMC) vseh radijskih oddajno-sprejemnih naprav, povezanih z aktivnimi medicinskimi vsadki z majhno močjo (LP-AMI) in pripadajočimi perifernimi napravami (LP-AMI-P).
Ta dokument zajema zahteve elektromagnetne združljivosti za radijske funkcije aktivnih medicinskih vsadkov z majhno močjo in pripadajočih perifernih naprav.
Ta dokument ne vključuje tehničnih specifikacij v zvezi z antenskim vhodom in sevanjem iz vhoda na ohišju radijskega sistema aktivnih medicinskih vsadkov z majhno močjo in pripadajočih perifernih naprav. Takšne tehnične specifikacije so navedene v ustreznih standardih za izdelek na področju učinkovite rabe radijskega spektra.
Dokument določa veljavne preskusne pogoje, oceno zmogljivosti in merila zmogljivosti za aktivne medicinske vsadke z majhno močjo in pripadajoče periferne naprave.
Opredelitve vrst aktivnih medicinskih vsadkov z majhno močjo in pripadajočih perifernih naprav, ki jih zajema ta dokument, so navedene v dodatku B.
Če se ta dokument in standard ETSI EN 301 489-1 [1] razlikujeta (na primer glede posebnih pogojev, opredelitev, kratic), imajo prednost določbe tega dokumenta.
Okoljska razvrstitev ter zahteve glede sevanja in odpornosti iz tega dokumenta so navedene v standardu ETSI EN 301 489-1 [1], razen posebnih pogojev iz tega dokumenta.
Ta dokument skupaj s standardom ETSI EN 301 489-1 [1] vključuje zahteve, s katerimi se dokazuje ustrezna raven elektromagnetne združljivosti, kot je določena v direktivi 2014/53/EU [i.1].
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LUHNWLYHElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU - Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunications11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 301 489-35 V2.1.1 (2016-12)SIST EN 301 489-35 V2.1.1:2017en01-februar-2017SIST EN 301 489-35 V2.1.1:2017SLOVENSKI
STANDARD
SIST EN 301 489-35 V2.1.1:2017
ETSI EN 301 489-35 V2.1.1 (2016-12) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU
HARMONISED EUROPEAN STANDARD SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)2
Reference REN/ERM-EMC-338 Keywords EMC, harmonised standard, health, 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 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)3 Contents Intellectual Property Rights . 5 Foreword . 5 Modal verbs terminology . 5 1 Scope . 6 2 References . 6 2.1 Normative references . 6 2.2 Informative references . 7 3 Definitions and abbreviations . 7 3.1 Definitions . 7 3.2 Abbreviations . 8 4 Test conditions . 8 4.1 General . 8 4.2 Arrangements for test signals . 9 4.2.0 General . 9 4.2.1 Arrangements for test signals at the input of transmitters . 9 4.2.2 Arrangements for test signals at the RF output of transmitters . 9 4.2.2.0 General . 9 4.2.2.1 ULP-AMI transmitters . 9 4.2.2.2 ULP-AMI-P transmitters . 9 4.2.3 Arrangements for test signals at the RF input of receivers . 9 4.2.4 Arrangements for test signals at the output of receivers . 10 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) . 10 4.3 RF exclusion band of radio equipment . 10 4.3.1 General . 10 4.3.2 Exclusion band for receivers . 10 4.3.3 Exclusion band for transmitters . 11 4.4 Narrow band responses of receivers or receivers which are part of transceivers . 11 4.5 Normal test modulation . 11 5 Performance assessment . 11 5.1 General . 11 5.2 Equipment which can provide a continuous communication link . 12 5.3 Equipment which does not provide a continuous communication link . 12 5.4 Ancillary equipment . 12 5.5 Equipment classification . 12 6 Performance criteria . 12 6.1 Classification of LP-AMI and LP-AMI-P devices . 12 6.2 General performance criteria . 13 6.3 Performance criteria and table . 13 6.4 Performance criteria for continuous phenomena applied to transmitters . 14 6.5 Performance criteria for transient phenomena applied to transmitters . 14 6.6 Performance criteria for continuous phenomena applied to receivers . 15 6.7 Performance criteria for transient phenomena applied to receivers . 15 7 Applicability overview . 15 7.1 EMC emission . 15 7.1.1 General . 15 7.1.2 Special conditions . 15 7.2 Immunity . 16 7.2.1 General . 16 7.2.2 Special conditions . 16 SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)4 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 20 Annex B (normative): Definitions of types of LP-AMI and LP-AMI-P devices in the scope of the present document . 22 B.1 LP-AMI and LP-AMI-P devices intended for operation in the frequency range 2 483,5 MHz to 2 500 MHz . 22 Annex C (normative): Test fixture for LP-AMI devices (Simulated man) . 23 History . 25
SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)5 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.1]. Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present document, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations. The present document is part 35 of a multi-part deliverable. Full details of the entire series can be found in ETSI EN 301 489-1 [1].
National transposition dates Date of adoption of this EN: 12 December 2016 Date of latest announcement of this EN (doa): 31 March 2017 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 September 2017 Date of withdrawal of any conflicting National Standard (dow): 30 September 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 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)6 1 Scope The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated with Low Power Active Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of ElectroMagnetic Compatibility (EMC). The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral devices (LP-AMI-P). Technical specifications related to the antenna port and emissions from the enclosure port of the radio system of LP-AMI and associated Peripheral devices (LP-AMI-P) are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document specifies the applicable test conditions, performance assessment, and performance criteria for of LP-AMI and associated Peripheral devices (LP-AMI-P). Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B. In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence. The environmental classification and the emission and immunity requirements used in the present document are as stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of electromagnetic compatibility as set out in Directive 2014/53/EU [i.1]. 2 References 2.1 Normative references References are 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 https://docbox.etsi.org/Reference/. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are necessary for the application of the present document. [1] ETSI EN 301 489-1 (V2.1.1) (11-2016): "ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU". NOTE: Available at http://www.etsi.org/deliver/etsi_en/301400_301499/30148901/02.01.01_30/en_30148901v020101v.pdf. [2] CENELEC EN 61000-4-5:2006: "Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test". [3] ETSI EN 301 559 (V2.1.1) (10-2016): "Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU". SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)7 2.2 Informative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. [i.1] Directive 2014/53/EU of the European Parliament and of the council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC. [i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)". [i.3] Commission Decision 2006/771/EC of 11 November 2006 on harmonization of the radio spectrum for use by short-range devices as amended by subsequent Commission Decisions. [i.4] http://niremf.ifac.cnr.it/. [i.5] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave Frequencies", (Physics Department, Kings College, London WC2R 2LS, UK. [i.6] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request to the European Committee for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/EU of the European Parliament and of the Council. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in ETSI EN 301 489-1 [1], ETSI EN 301 559 [3], Directive 2014/53/EU [i.1] and the following apply: Active Implantable Medical Device (AIMD): any active medical device (AMD) which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any source of power Active Medical Implant (AMI): diagnostic or therapeutic device designed to be implanted in a human body containing a power source and a transceiver using the 2 483,5 MHz to 2 500 MHz frequency band for the purpose of providing a two-way digital communications link life supporting equipment: equipment whose continued normal operation is required in order to sustain life Low Power Active Medical Implant (LP-AMI): low power radio part of any active medical device (AMD), which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an equipment that communicates indoor with one or more LP-AMI to establish an AMICL NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical implant event". SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)8 Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the: • diagnosis, prevention, monitoring, treatment or alleviation of disease or injury and for prolongation of life; • investigation, replacement or modification of the anatomy or of a physiological process; • control of conception; and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means Medical Implant Communications Link (MICL): collections of transmission that may or may not be continuous, between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient related information in communications service Medical Implant Communications System (MICS): specific system providing radiocommunications between an LP-AMI and an associated LP-AMI-P 3.2 Abbreviations For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 [1], ETSI EN 301 559 [3], Directive 2014/53/EU [i.1] and the following apply: AC Alternating Current AIMD Active Implantable Medical Device AMD Active Medical Device AMI Active Medical Implant AMICL Active Medical Implant Communication Link dB decibel dBm absolute power level referred to one milliwatt DC Direct Current e.i.r.p. effective isotropically radiated power EMC ElectroMagnetic Compatibility EUT Equipment Under Test fo operating frequency ISM Industrial Scientific Medical excluding telecommunications LP-AMI Low Power Active Medical Implant LP-AMI-P Low Power Active Medical Implant Peripheral MD Medical Device MICL Medical Implant Communications Link MICS Medical Implant Communications System RF Radio Frequency SRD Short Range Devices 4 Test conditions 4.1 General For the purposes of the present document, the test conditions of the ETSI EN 301 489-1 [1], clause 4, shall apply as appropriate. Further product related test conditions for LP-AMI and associated Peripheral devices (LP-AMI-P) are specified in the present document. For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present document, clauses 4.1 to 4.5 shall apply. SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)9 Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with several types of antenna the test shall be repeated for each type of antenna. LP-AMI devices (active medical implants) are designed to be implanted within a human body. These radio systems are isolated from disturbances by the surrounding body tissue. In order to adequately assess the EMC characteristics of active medical implants devices , the use of a simulated man is necessary. See annex C for additional details. The provisions of annex C are intended to provide an operational environment that simulates, to the extent possible, actual usage conditions for internal implanted devices. It is necessary to use this or another appropriate special fixture when making emission measurements and immunity tests with radiated RF fields. 4.2 Arrangements for test signals 4.2.0 General The provisions of the ETSI EN 301 489-1 [1], clause 4.2 shall apply. 4.2.1 Arrangements for test signals at the input of transmitters The provisions of the ETSI EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications: • The transmitter shall be modulated with normal test modulation as specified for that type of equipment (see clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall be used. 4.2.2 Arrangements for test signals at the RF output of transmitters 4.2.2.0 General The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification: • The manufacturer may provide a suitable companion receiver or another device that can be used to set up a communications link and/or to receive messages. 4.2.2.1 ULP-AMI transmitters For ULP-AMI transmitters the test fixture described in annex C may be used: • The manufacturer shall provide a suitable receiver that can be used to monitor the medical implant communications link. 4.2.2.2 ULP-AMI-P transmitters The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications: • LP-AMI-P devices are designed to be used externally to a human body; • the manufacturer shall provide a suitable receiver that can be used to monitor the medical implant communications link. 4.2.3 Arrangements for test signals at the RF input of receivers The provisions of ETSI EN 301 489-1 [1], clause 4.2.3 shall apply with the following modifications: • the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as specified for that type of equipment (clause 4.5); • the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level of the receiver, but in all cases it shall be below the overload characteristics of the receiver; SIST EN 301 489-35 V2.1.1:2017
ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)10 • the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant communications link. 4.2.4 Arrangements for test signals at the output of receivers The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate: • If direct access to the receiver output of the ULP-AMI and associated ULP-AMI-P is not possible, then the manufacturer shall provide the method by which the receiver's functionality can be monitored during the immunity tests. 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate: • if direct access to the receiver output of the LP-AMI and associated LP-AMI-P is not possible, then the manufacturer shall provide the method by which the receiver's functionality can be monitored during the immunity tests. 4.3 RF exclusion band of radio equipment 4.3.1 General The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the clauses 4.3.2 and 4.3.3 of the present document. The frequencies on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequencies on which the transmitter part of the EUT is intended to operate shall be excluded from emission measurements when performed in transmit mode of operation. During emission measurements, a frequency exclusion band does not apply for the receiver part of LP-AMIs and/or associated LP-AMI-Ps. 4.3.2 Exclusion band for receivers The exclusion band for receivers (including receivers that are part of transceivers), defined in table 1, is determined as follows: • for receivers capable of operating on 16 or more channels within the frequency band specified in table 1 and not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated extension value shall be based on the operating frequency; • for receivers capable of operating on more than one frequency and having an alignment range, the lower frequency of the exclusion band is the lower frequency of the alignment range minus the extension value given in table 1, and the upper frequency of the exclusion band is the upper frequency of the alignment range plus the extension value given in table 1. The calculated extension values shall be based on the centre frequency of the alignment range; • for wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the exclusion band is the lower frequency of the i
...
ETSI EN 301 489-35 V2.1.1 (2016-12)
HARMONISED EUROPEAN STANDARD
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 35: Specific requirements for
Low Power Active Medical Implants (LP-AMI)
operating in the 2 483,5 MHz to 2 500 MHz bands;
Harmonised Standard covering the essential requirements
of article 3.1(b) of Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 ETSI EN 301 489-35 V2.1.1 (2016-12)
Reference
REN/ERM-EMC-338
Keywords
EMC, harmonised standard, health, 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 301 489-35 V2.1.1 (2016-12)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 8
4 Test conditions . 8
4.1 General . 8
4.2 Arrangements for test signals . 9
4.2.0 General . 9
4.2.1 Arrangements for test signals at the input of transmitters . 9
4.2.2 Arrangements for test signals at the RF output of transmitters . 9
4.2.2.0 General . 9
4.2.2.1 ULP-AMI transmitters . 9
4.2.2.2 ULP-AMI-P transmitters . 9
4.2.3 Arrangements for test signals at the RF input of receivers . 9
4.2.4 Arrangements for test signals at the output of receivers . 10
4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an
associated ULP-AMI-P) . 10
4.3 RF exclusion band of radio equipment . 10
4.3.1 General . 10
4.3.2 Exclusion band for receivers . 10
4.3.3 Exclusion band for transmitters . 11
4.4 Narrow band responses of receivers or receivers which are part of transceivers . 11
4.5 Normal test modulation . 11
5 Performance assessment . 11
5.1 General . 11
5.2 Equipment which can provide a continuous communication link . 12
5.3 Equipment which does not provide a continuous communication link . 12
5.4 Ancillary equipment . 12
5.5 Equipment classification . 12
6 Performance criteria . 12
6.1 Classification of LP-AMI and LP-AMI-P devices . 12
6.2 General performance criteria . 13
6.3 Performance criteria and table . 13
6.4 Performance criteria for continuous phenomena applied to transmitters . 14
6.5 Performance criteria for transient phenomena applied to transmitters . 14
6.6 Performance criteria for continuous phenomena applied to receivers . 15
6.7 Performance criteria for transient phenomena applied to receivers . 15
7 Applicability overview . 15
7.1 EMC emission . 15
7.1.1 General . 15
7.1.2 Special conditions . 15
7.2 Immunity . 16
7.2.1 General . 16
7.2.2 Special conditions . 16
ETSI
---------------------- Page: 3 ----------------------
4 ETSI EN 301 489-35 V2.1.1 (2016-12)
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 20
Annex B (normative): Definitions of types of LP-AMI and LP-AMI-P devices in the scope of
the present document . 22
B.1 LP-AMI and LP-AMI-P devices intended for operation in the frequency range 2 483,5 MHz to
2 500 MHz . 22
Annex C (normative): Test fixture for LP-AMI devices (Simulated man) . 23
History . 25
ETSI
---------------------- Page: 4 ----------------------
5 ETSI EN 301 489-35 V2.1.1 (2016-12)
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.1].
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive and associated
EFTA regulations.
The present document is part 35 of a multi-part deliverable. Full details of the entire series can be found in ETSI
EN 301 489-1 [1].
National transposition dates
Date of adoption of this EN: 12 December 2016
Date of latest announcement of this EN (doa): 31 March 2017
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 September 2017
Date of withdrawal of any conflicting National Standard (dow): 30 September 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: 5 ----------------------
6 ETSI EN 301 489-35 V2.1.1 (2016-12)
1 Scope
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Low Power Active Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of
ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral
devices (LP-AMI-P).
Technical specifications related to the antenna port and emissions from the enclosure port of the radio system of
LP-AMI and associated Peripheral devices (LP-AMI-P) are not included in the present document. Such technical
specifications are found in the relevant product standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for of
LP-AMI and associated Peripheral devices (LP-AMI-P).
Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of
electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].
2 References
2.1 Normative references
References are 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
https://docbox.etsi.org/Reference/.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
[1] ETSI EN 301 489-1 (V2.1.1) (11-2016): "ElectroMagnetic Compatibility (EMC) standard for
radio equipment and services; Part 1: Common technical requirements; Harmonised Standard
covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential
requirements of article 6 of Directive 2014/30/EU".
NOTE: Available at
http://www.etsi.org/deliver/etsi_en/301400_301499/30148901/02.01.01_30/en_30148901v020101v.pdf.
[2] CENELEC EN 61000-4-5:2006: "Electromagnetic compatibility (EMC) - Part 4-5: Testing and
measurement techniques - Surge immunity test".
[3] ETSI EN 301 559 (V2.1.1) (10-2016): "Short Range Devices (SRD); Low Power Active Medical
Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range
2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of
article 3.2 of the Directive 2014/53/EU".
ETSI
---------------------- Page: 6 ----------------------
7 ETSI EN 301 489-35 V2.1.1 (2016-12)
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] Directive 2014/53/EU of the European Parliament and of the council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment and repealing Directive 1999/5/EC.
[i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.3] Commission Decision 2006/771/EC of 11 November 2006 on harmonization of the radio spectrum
for use by short-range devices as amended by subsequent Commission Decisions.
[i.4] http://niremf.ifac.cnr.it/.
[i.5] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave
Frequencies", (Physics Department, Kings College, London WC2R 2LS, UK.
[i.6] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electrotechnical Standardisation and to the European
Telecommunications Standards Institute as regards radio equipment in support of Directive
2014/53/EU of the European Parliament and of the Council.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in ETSI EN 301 489-1 [1], ETSI
EN 301 559 [3], Directive 2014/53/EU [i.1] and the following apply:
Active Implantable Medical Device (AIMD): any active medical device (AMD) which is intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure
Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any
source of power
Active Medical Implant (AMI): diagnostic or therapeutic device designed to be implanted in a human body containing
a power source and a transceiver using the 2 483,5 MHz to 2 500 MHz frequency band for the purpose of providing a
two-way digital communications link
life supporting equipment: equipment whose continued normal operation is required in order to sustain life
Low Power Active Medical Implant (LP-AMI): low power radio part of any active medical device (AMD), which is
intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention
into a natural orifice, and which is intended to remain after the procedure
Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an
equipment that communicates indoor with one or more LP-AMI to establish an AMICL
NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
ETSI
---------------------- Page: 7 ----------------------
8 ETSI EN 301 489-35 V2.1.1 (2016-12)
Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be
used for human beings in the:
• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury and for prolongation of life;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic
means, but which may be assisted in its function by such means
Medical Implant Communications Link (MICL): collections of transmission that may or may not be continuous,
between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient
related information in communications service
Medical Implant Communications System (MICS): specific system providing radiocommunications between an
LP-AMI and an associated LP-AMI-P
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 [1], ETSI EN 301 559 [3],
Directive 2014/53/EU [i.1] and the following apply:
AC Alternating Current
AIMD Active Implantable Medical Device
AMD Active Medical Device
AMI Active Medical Implant
AMICL Active Medical Implant Communication Link
dB decibel
dBm absolute power level referred to one milliwatt
DC Direct Current
e.i.r.p. effective isotropically radiated power
EMC ElectroMagnetic Compatibility
EUT Equipment Under Test
f operating frequency
o
ISM Industrial Scientific Medical excluding telecommunications
LP-AMI Low Power Active Medical Implant
LP-AMI-P Low Power Active Medical Implant Peripheral
MD Medical Device
MICL Medical Implant Communications Link
MICS Medical Implant Communications System
RF Radio Frequency
SRD Short Range Devices
4 Test conditions
4.1 General
For the purposes of the present document, the test conditions of the ETSI EN 301 489-1 [1], clause 4, shall apply as
appropriate. Further product related test conditions for LP-AMI and associated Peripheral devices (LP-AMI-P) are
specified in the present document.
For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present
document, clauses 4.1 to 4.5 shall apply.
ETSI
---------------------- Page: 8 ----------------------
9 ETSI EN 301 489-35 V2.1.1 (2016-12)
Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the
antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with
several types of antenna the test shall be repeated for each type of antenna.
LP-AMI devices (active medical implants) are designed to be implanted within a human body. These radio systems are
isolated from disturbances by the surrounding body tissue. In order to adequately assess the EMC characteristics of
active medical implants devices , the use of a simulated man is necessary. See annex C for additional details. The
provisions of annex C are intended to provide an operational environment that simulates, to the extent possible, actual
usage conditions for internal implanted devices. It is necessary to use this or another appropriate special fixture when
making emission measurements and immunity tests with radiated RF fields.
4.2 Arrangements for test signals
4.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2 shall apply.
4.2.1 Arrangements for test signals at the input of transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications:
• The transmitter shall be modulated with normal test modulation as specified for that type of equipment (see
clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall
be used.
4.2.2 Arrangements for test signals at the RF output of transmitters
4.2.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification:
• The manufacturer may provide a suitable companion receiver or another device that can be used to set up a
communications link and/or to receive messages.
4.2.2.1 ULP-AMI transmitters
For ULP-AMI transmitters the test fixture described in annex C may be used:
• The manufacturer shall provide a suitable receiver that can be used to monitor the medical implant
communications link.
4.2.2.2 ULP-AMI-P transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications:
• LP-AMI-P devices are designed to be used externally to a human body;
• the manufacturer shall provide a suitable receiver that can be used to monitor the medical implant
communications link.
4.2.3 Arrangements for test signals at the RF input of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.3 shall apply with the following modifications:
• the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as
specified for that type of equipment (clause 4.5);
• the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level of the receiver, but
in all cases it shall be below the overload characteristics of the receiver;
ETSI
---------------------- Page: 9 ----------------------
10 ETSI EN 301 489-35 V2.1.1 (2016-12)
• the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant
communications link.
4.2.4 Arrangements for test signals at the output of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate:
• If direct access to the receiver output of the ULP-AMI and associated ULP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
4.2.5 Arrangements for testing transmitter and receiver together
(as a system: ULP-AMI together with an associated ULP-AMI-P)
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate:
• if direct access to the receiver output of the LP-AMI and associated LP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
4.3 RF exclusion band of radio equipment
4.3.1 General
The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the
clauses 4.3.2 and 4.3.3 of the present document.
The frequencies on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity
tests.
The frequencies on which the transmitter part of the EUT is intended to operate shall be excluded from emission
measurements when performed in transmit mode of operation.
During emission measurements, a frequency exclusion band does not apply for the receiver part of LP-AMIs and/or
associated LP-AMI-Ps.
4.3.2 Exclusion band for receivers
The exclusion band for receivers (including receivers that are part of transceivers), defined in table 1, is determined as
follows:
• for receivers capable of operating on 16 or more channels within the frequency band specified in table 1 and
not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used
frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is
the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated
extension value shall be based on the operating frequency;
• for receivers capable of operating on more than one frequency and having an alignment range, the lower
frequency of the exclusion band is the lower frequency of the alignment range minus the extension value given
in table 1, and the upper frequency of the exclusion band is the upper frequency of the alignment range plus
the extension value given in table 1. The calculated extension values shall be based on the centre frequency of
the alignment range;
• for wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the
exclusion band is the lower frequency of the intended operating band minus the extension value given in
table 1 and the upper frequency of the exclusion band is the upper frequency of the intended operating band
plus the extension value given in table 1, or the total exclusion band is twice the intended operating frequency
band of the receiver c
...
Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
HARMONISED EUROPEAN STANDARD
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Harmonised Standard covering the essential requirements
of article 3.1(b) of Directive 2014/53/EU;
Part 35: Specific requirements for
Low Power Active MedicalImplants (LP-AMI)
operating in the 2 483,5 MHz to 2 500 MHz bands
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
Reference
REN/ERM-EMC-338
Keywords
EMC, harmonised standard, health, radio,
regulation
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 301 489-35 V2.1.0 (2016-09)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 8
4 Test conditions . 8
4.1 General . 8
4.2 Arrangements for test signals . 9
4.2.0 General . 9
4.2.1 Arrangements for test signals at the input of transmitters . 9
4.2.2 Arrangements for test signals at the RF output of transmitters . 9
4.2.2.0 General . 9
4.2.2.1 ULP-AMI transmitters . 9
4.2.2.2 ULP-AMI-P transmitters . 9
4.2.3 Arrangements for test signals at the RF input of receivers . 9
4.2.4 Arrangements for test signals at the output of receivers . 10
4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an
associated ULP-AMI-P) . 10
4.3 RF exclusion band of radio equipment . 10
4.3.1 General . 10
4.3.2 Exclusion band for receivers . 10
4.3.2 Exclusion band for transmitters . 11
4.4 Narrow band responses of receivers or receivers which are part of transceivers . 11
4.5 Normal test modulation . 11
5 Performance assessment . 11
5.1 General . 11
5.2 Equipment which can provide a continuous communication link . 12
5.3 Equipment which does not provide a continuous communication link . 12
5.4 Ancillary equipment . 12
5.5 Equipment classification . 12
6 Performance criteria . 12
6.1 Classification of LP-AMI and LP-AMI-P devices . 12
6.2 General performance criteria . 13
6.3 Performance criteria and table . 13
6.4 Performance criteria for continuous phenomena applied to transmitters . 14
6.5 Performance criteria for transient phenomena applied to transmitters . 14
6.6 Performance criteria for continuous phenomena applied to receivers . 15
6.7 Performance criteria for transient phenomena applied to receivers . 15
7 Applicability overview . 15
7.1 EMC emission . 15
7.1.1 General . 15
7.1.2 Special conditions . 15
7.2 Immunity . 16
7.2.1 General . 16
7.2.2 Special conditions . 16
ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 20
Annex B (normative): Definitions of types of LP-AMI and LP-AMI-P devices in the scope of
the present document . 22
B.1 LP-AMI and LP-AMI-P devices intended for operation in the frequency range 2 483,5 MHz to
2 500 MHz . 22
Annex C (normative): Test fixture for LP-AMI devices (Simulated man) . 23
History . 25
ETSI
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
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.1].
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive and associated
EFTA regulations.
The present document is part 35 of a multi-part deliverable. Full details of the entire series can be found in ETSI
EN 301 489-1 [1].
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.
ETSI
---------------------- Page: 5 ----------------------
6 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
1 Scope
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Low Power Active Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of
ElectroMagnetic Compatibility (EMC).
The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral
devices (LP-AMI-P).
Technical specifications related to the antenna port and emissions from the enclosure port of the radio system of
LP-AMI and associated Peripheral devices (LP-AMI-P) are not included in the present document. Such technical
specifications are found in the relevant product standards for the effective use of the radio spectrum.
The present document specifies the applicable test conditions, performance assessment, and performance criteria for of
LP-AMI and associated Peripheral devices (LP-AMI-P).
Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of
electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].
2 References
2.1 Normative references
References are 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
https://docbox.etsi.org/Reference/.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
[1] ETSI EN 301 489-1 (V2.1.0) (04-2016): "ElectroMagnetic Compatibility (EMC) standard for
radio equipment and services; Harmonised Standard covering the essential requirements of
article 3.1(b) of the Directive 2014/53/EU and the essential requirements of article 6 of the
Directive 2014/30/EU; Part 1: Common technical requirements".
NOTE: Available at
http://www.etsi.org/deliver/etsi_en/301400_301499/30148901/02.01.00_20/en_30148901v020100a.pdf.
[2] CENELEC EN 61000-4-5:2006: "Electromagnetic compatibility (EMC) - Part 4-5: Testing and
measurement techniques - Surge immunity test".
[3] ETSI EN 301 559 (V2.0.1) (06-2016): "Short Range Devices (SRD); Low Power Active Medical
Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range
2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of
article 3.2 of the Directive 2014/53/EU".
ETSI
---------------------- Page: 6 ----------------------
7 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] Directive 2014/53/EU of the European Parliament and of the council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment and repealing Directive 1999/5/EC.
[i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.3] Commission Decision 2006/771/EC of 11 November 2006 on harmonization of the radio spectrum
for use by short-range devices as amended by subsequent Commission Decisions.
[i.4] http://niremf.ifac.cnr.it/.
[i.5] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave
Frequencies", (Physics Department, Kings College, London WC2R 2LS, UK.
[i.6] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electrotechnical Standardisation and to the European
Telecommunications Standards Institute as regards radio equipment in support of Directive
2014/53/EU of the European Parliament and of the Council.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in ETSI EN 301 489-1 [1], ETSI
EN 301 559 [3], Directive 2014/53/EU [i.1] and the following apply:
Active Implantable Medical Device (AIMD): any active medical device (AMD) which is intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure
Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any
source of power
Active Medical Implant (AMI): diagnostic or therapeutic device designed to be implanted in a human body containing
a power source and a transceiver using the 2 483,5 MHz to 2 500 MHz frequency band for the purpose of providing a
two-way digital communications link
life supporting equipment: equipment whose continued normal operation is required in order to sustain life
Low Power Active Medical Implant (LP-AMI): low power radio part of any active medical device (AMD), which is
intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention
into a natural orifice, and which is intended to remain after the procedure
Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an
equipment that communicates indoor with one or more LP-AMI to establish an AMICL
NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
ETSI
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8 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be
used for human beings in the:
• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury and for prolongation of life;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic
means, but which may be assisted in its function by such means
Medical Implant Communications Link (MICL): collections of transmission that may or may not be continuous,
between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient
related information in communications service
Medical Implant Communications System (MICS): specific system providing radiocommunications between an
LP-AMI and an associated LP-AMI-P
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 [1], ETSI EN 301 559 [3],
Directive 2014/53/EU [i.1] and the following apply:
AC Alternating Current
AIMD Active Implantable Medical Device
AMD Active Medical Device
AMI Active Medical Implant
AMICL Active Medical Implant Communication Link
dB decibel
dBm absolute power level referred to one milliwatt
DC Direct Current
e.i.r.p. effective isotropically radiated power
EMC ElectroMagnetic Compatibility
EUT Equipment Under Test
f operating frequency
o
ISM Industrial Scientific Medical excluding telecommunications
LP-AMI Low Power Active Medical Implant
LP-AMI-P Low Power Active Medical Implant Peripheral
MD Medical Device
MICL Medical Implant Communications Link
MICS Medical Implant Communications System
RF Radio Frequency
SRD Short Range Devices
4 Test conditions
4.1 General
For the purposes of the present document, the test conditions of the ETSI EN 301 489-1 [1], clause 4, shall apply as
appropriate. Further product related test conditions for LP-AMI and associated Peripheral devices (LP-AMI-P) are
specified in the present document.
For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present
document, clauses 4.1 to 4.5 shall apply.
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9 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the
antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with
several types of antenna the test shall be repeated for each type of antenna.
LP-AMI devices (active medical implants) are designed to be implanted within a human body. These radio systems are
isolated from disturbances by the surrounding body tissue. In order to adequately assess the EMC characteristics of
active medical implants devices , the use of a simulated man is necessary. See annex C for additional details. The
provisions of annex C are intended to provide an operational environment that simulates, to the extent possible, actual
usage conditions for internal implanted devices. It is necessary to use this or another appropriate special fixture when
making emission measurements and immunity tests with radiated RF fields.
4.2 Arrangements for test signals
4.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2 shall apply.
4.2.1 Arrangements for test signals at the input of transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications:
• The transmitter shall be modulated with normal test modulation as specified for that type of equipment (see
clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall
be used.
4.2.2 Arrangements for test signals at the RF output of transmitters
4.2.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification:
• The manufacturer may provide a suitable companion receiver or another device that can be used to set up a
communications link and/or to receive messages.
4.2.2.1 ULP-AMI transmitters
For ULP-AMI transmitters the test fixture described in annex C may be used:
• The manufacturer shall provide a suitable receiver that can be used to monitor the medical implant
communications link.
4.2.2.2 ULP-AMI-P transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications:
• LP-AMI-P devices are designed to be used externally to a human body;
• the manufacturer shall provide a suitable receiver that can be used to monitor the medical implant
communications link.
4.2.3 Arrangements for test signals at the RF input of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.3 shall apply with the following modifications:
• the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as
specified for that type of equipment (clause 4.5);
• the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level of the receiver, but
in all cases it shall be below the overload characteristics of the receiver;
ETSI
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10 Draft ETSI EN 301 489-35 V2.1.0 (2016-09)
• the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant
communications link.
4.2.4 Arrangements for test signals at the output of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate:
• If direct access to the receiver output of the ULP-AMI and associated ULP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
4.2.5 Arrangements for testing transmitter and receiver together
(as a system: ULP-AMI together with an associated ULP-AMI-P)
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the following modification, if appropriate:
• if direct access to the receiver output of the LP-AMI and associated LP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
4.3 RF exclusion band of radio equipment
4.3.1 General
The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the
clauses 4.3.2 and 4.3.3 of the present document.
The frequencies on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity
tests.
The frequencies on which the transmitter part of the EUT is intended to operate shall be excluded from emission
measurements when performed in transmit mode of operation.
During emission measurements, a frequency exclusion band does not apply for the receiver part of LP-AMIs and/or
associated LP-AMI-Ps.
4.3.2 Exclusion band for receivers
The exclusion band for receivers (including receivers that are part of transceivers), defined in table 1, is determined as
follows:
• for receivers capable of operating on 16 or more channels within the frequency band specified in table 1 and
not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used
frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is
the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated
extension value shall be based on the operating frequency;
• for receivers capable of operating on more than one frequency and having an alignment range, the lower
frequency of the exclusion band is the lower frequency of the alignment range minus the extension value given
in table 1, and the upper frequency of the exclusion band is the upper frequency of the alignment range plus
the extension value given in table 1. The calculated extension values shall be based on the centre frequency of
the alignment range;
• for wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the
exclusion band is the lower frequency of the intended operating band minus the extension value given in
table 1 and the upper frequency of the exclusion band is the upper
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