SIST EN 301 489-31 V2.2.1:2019

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 301 489-31 V2.2.1 (2019-04)SIST EN 301 489-31 V2.2.1:2019en01-junij-2019SIST EN 301 489-31 V2.2.1:2019SLOVENSKI

ETSI EN 301 489-31 V2.2.1 (2019-04) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU

Reference REN/ERM-EMC-376 Keywords EMC, harmonised standard, LF, radio, regulation, short range 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 301 489-31 V2.2.1 (2019-04)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, symbols and abbreviations ................................................................................................... 7 3.1 Definitions .......................................................................................................................................................... 7 3.2 Symbols .............................................................................................................................................................. 7 3.3 Abbreviations ..................................................................................................................................................... 8 4 Test conditions ......................................................................................................................................... 8 4.1 General ............................................................................................................................................................... 8 4.2 Arrangements for test signals ............................................................................................................................. 8 4.2.0 General .......................................................................................................................................................... 8 4.2.1 Arrangements for test signals at the input of transmitters ............................................................................. 8 4.2.2 Arrangements for test signals at the RF output of transmitters ..................................................................... 9 4.2.2.1 General .................................................................................................................................................... 9 4.2.2.2 ULP-AMI transmitters ............................................................................................................................ 9 4.2.2.3 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 ............................................................................... 9 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) ............................................................................................................................... 9 4.3 RF exclusion band of radio equipment ............................................................................................................. 10 4.3.0 General ........................................................................................................................................................ 10 4.3.1 Exclusion bands for receiver ....................................................................................................................... 10 4.3.2 Exclusion band for transmitters .................................................................................................................. 10 4.4 Narrow band responses of receivers or receivers which are part of transceivers ............................................. 10 4.5 Normal test modulation .................................................................................................................................... 10 5 Performance assessment ......................................................................................................................... 10 5.1 General ............................................................................................................................................................. 10 5.2 Equipment which can provide a continuous communication link .................................................................... 11 5.3 Equipment which does not provide a continuous communication link ............................................................ 11 5.4 Ancillary equipment ......................................................................................................................................... 11 5.5 Equipment classification .................................................................................................................................. 11 6 Performance criteria ............................................................................................................................... 11 6.1 Classification of ULP-AMI and ULP-AMI-P .................................................................................................. 11 6.2 General performance criteria ............................................................................................................................ 12 6.3 Performance criteria and table .......................................................................................................................... 12 6.4 Performance criteria for continuous phenomena applied to transmitters ......................................................... 13 6.5 Performance criteria for transient phenomena applied to transmitters ............................................................. 13 6.6 Performance criteria for continuous phenomena applied to receivers .............................................................. 14 6.7 Performance criteria for transient phenomena applied to receivers .................................................................. 14 7 Applicability overview ........................................................................................................................... 14 7.1 EMC emission .................................................................................................................................................. 14 7.1.1 General ........................................................................................................................................................ 14 7.1.2 Special conditions ....................................................................................................................................... 14 7.2 Immunity .......................................................................................................................................................... 14 7.2.1 General ........................................................................................................................................................ 14 7.2.2 Special conditions ....................................................................................................................................... 15 SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)4 Annex A (informative): Relationship between the present document and the essential requirements of Directive 2014/53/EU ......................................................... 18 Annex B (informative): Test fixture for ULP-AMI (Simulated man) ............................................... 20 Annex C (informative): Simultaneous testing of ULP-AMI/ULP-AMI-P and parts covered by AIMD .............................................................................................................. 22 Annex D (informative): Change History .............................................................................................. 23 History .............................................................................................................................................................. 24

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)5 Intellectual Property Rights Essential patents IPRs essential or potentially essential to normative deliverables 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. Trademarks The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners. ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks. 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.4] 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 31 of a multi-part deliverable. Full details of the entire series can be found in part 1 [1].

National transposition dates Date of adoption of this EN: 20 June 2017 Date of latest announcement of this EN (doa): 31 July 2019 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 January 2020 Date of withdrawal of any conflicting National Standard (dow): 31 January 2021

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 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)6 1 Scope The present document together with ETSI EN 301 489-1 [1] covers the assessment of all radio transceivers associated with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of ElectroMagnetic Compatibility (EMC). Non-radio parts of the above equipment may be covered by other directives and/or standards when applicable. Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these devices 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 assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps. 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 specific, identified by date of publication and/or edition number or version number. Only the cited version 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 (V2.2.0) (03-2017): "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". [2] ETSI EN 302 195 (V2.1.1) (06-2016): "Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU". [3] CENELEC EN 61000-4-5 (2014): "Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test". SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)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] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave Frequencies", Physics Department, Kings College, London WC2R 2LS, UK. [i.3] Void. [i.4] 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, symbols 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 302 195 [2], Directive 2014/53/EU [i.1] and the following apply, unless otherwise ascribed herein: emission bandwidth: bandwidth between two points that are 20 dB down on either side of the frequency with the maximum level in the modulation envelope environmental profile: range of environmental conditions under which equipment within the scope of the present document is required to comply with the provisions of the present document H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the field can be measured life supporting equipment: equipment or system that includes at least one function that is intended to actively keep alive or resuscitate patients and the failure of which is likely to lead to serious injury or death of a patient non-radio part: those portions of a device not used for communication via electromagnetic waves radio part: that portion of a device used for communication via electromagnetic waves Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an active medical implant Ultra Low Power Active Medical Implant Peripheral device (ULP-AMI-P): radio part of equipment outside the human body, including body worn devices and monitors, used to program and/or control or receive data from an ULP-AMI 3.2 Symbols For the purposes of the present document, the symbols given in ETSI EN 301 489-1 [1], ETSI EN 302 195 [2] and Directive 2014/53/EU [i.1] apply. SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)8 3.3 Abbreviations For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 [1], ETSI EN 302 195 [2], Directive 2014/53/EU [i.1] and the following apply, unless otherwise ascribed herein: AC Alternating Current AIMD Active Implantable Medical Device AMI Active Medical Implant DC Direct Current EMC ElectroMagnetic Compatibility EUT Equipment Under Test ISM Industria, Scientific and Medical RF Radio Frequency ULP-AMI Ultra Low Power-Active Medical Implant ULP-AMI-P Ultra Low Power-Active Medical Implant Peripheral device 4 Test conditions 4.1 General For the purposes of the present document, the test conditions of ETSI EN 301 489-1 [1], clause 4 shall apply as appropriate. Further product related test conditions for equipment covered by the scope of the present document are specified herein. 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. 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. Active Medical Implant inductive devices 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 as they are intended to be used, the use of a simulated man is permitted. See annex B for additional details. The provisions of annex B are intended to provide an operational environment that simulates, to the extent possible, actual usage conditions for internal implanted devices. It may be 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 (clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall be used. SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)9 4.2.2 Arrangements for test signals at the RF output of transmitters 4.2.2.1 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. 4.2.2.2 ULP-AMI transmitters For ULP-AMI transmitters the test fixture described in annex B may be used. The manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the medical implant communications link. 4.2.2.3 ULP-AMI-P transmitters The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications: • ULP-AMI-Ps are designed to be used external to a human body; • the manufacturer shall provide a suitable receiver or alternate technique 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 sufficiently above the threshold sensitivity level to provide reliable communication of the receiver, but in all cases it shall be below the overload characteristics of the receiver; • the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant communications link if needed. 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 4.2.5 shall apply with the following modification: • The transmitter of an ULP-AMI and the receiver of an associated ULP-AMI-P or the receiver of an ULP-AMI and the transmitter of an associated ULP-AMI-P may be tested together, if appropriate and agreed by the manufacturer and the test laboratory (size of devices, etc.). In this case both EUTs shall be located in their respective test environment and exposed simultaneously to the EMC phenomena. SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)10 4.3 RF exclusion band of radio equipment 4.3.0 General The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the clauses 4.3.1 and 4.3.2. The frequency, on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequency 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 ULP-AMIs and/or associated ULP-AMI-Ps. 4.3.1 Exclusion bands for receiver No measurements for conducted and radiated RF immunity test shall be performed below 315 kHz. Table 1: Void 4.3.2 Exclusion band for transmitters For wide band transmitters, i.e. transmitters in a non-channelized frequency band, the exclusion band is twice the intended operating frequency band (i.e. 315 kHz or less) centred on the centre frequency of the intended operating frequency band. In case the receiver and transmitter are tested together as a system (see clause 4.2.5) the exclusion band defined for receiver or the exclusion band defined for transmitters shall be used, whichever is greater. 4.4 Narrow band responses of receivers or receivers which are part of transceivers The provision of ETSI EN 301 489-1 [1], clause 4.4 shall apply. 4.5 Normal test modulation The RF carrier shall be modulated with a test signal that produces specific selective messages or commands as stated by the manufacturer, representing a practical selection of usable selective messages/commands. The manufacturer shall declare the format of the modulation signal and any error detection and correction involved. Where transmitters do not have a modulation input port, the internal equipment modulation is used. 5 Performance assessment 5.1 General The provision of ETSI EN 301 489-1 [1], clause 5.1 shall apply. The manufacturer shall at the time of submission of the device(s) for test, supply the necessary general information as requested in ETSI EN 301 489-1 [1], clause 5.1. Additionally he shall supply the following product-related information: • the class of the device selected by the manufacturer according to table 2 (see clause 6.1). The performance assessment is dependent on whether the type of device is an ULP-AMI or an ULP-AMI-P. SIST EN 301 489-31 V2.2.1:2019

ETSI ETSI EN 301 489-31 V2.2.1 (2019-04)11 For both types of devices the performance assessment is based on: • the maintenance of function(s); • the way an eventual loss of function(s) can be recovered; • the unintentional behaviour of the EUT. For both types of devices it shall be possible to assess the performance by monitoring the intended functions before, during and after the tests. 5.2 Equipment which can provide a continuous communi