SIST EN 301 489-35 V2.1.1:2017

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

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

Reference REN/ERM-EMC-338 Keywords EMC, harmonised standard, health, radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE

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

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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

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