SIST EN 301 489-35 V1.1.2:2013

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Electromagnetic compatibility and Radio spectrum Matters (ERM) - 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 bands33.100.01Elektromagnetna 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:EN 301 489-35 Version 1.1.2SIST EN 301 489-35 V1.1.2:2013en01-december-2013SIST EN 301 489-35 V1.1.2:2013SLOVENSKI

ETSI EN 301 489-35 V1.1.2 (2013-10) Electromagnetic compatibility and Radio spectrum Matters (ERM); 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

Reference DEN/ERM-EMC-313 Keywords EMC, health, radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE

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ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)3 Contents Intellectual Property Rights ................................................................................................................................ 5 Foreword ............................................................................................................................................................. 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 4.2.1 Arrangements for test signals at the input of the transmitter ........................................................................ 9 4.2.2 Arrangements for test signals at the output of the transmitter ...................................................................... 9 4.2.2.1 LP-AMI transmitters ............................................................................................................................... 9 4.2.2.2 LP-AMI-P transmitters ............................................................................................................................ 9 4.2.3 Arrangements for test signals at the input of the receiver ............................................................................. 9 4.2.4 Arrangements for test signals at the output of the receiver ......................................................................... 10 4.2.5 Arrangements for testing transmitter and receiver together (as a system: LP-AMI together with an associated LP-AMI-P) ................................................................................................................................ 10 4.3 Exclusion bands ................................................................................................................................................ 10 4.3.1 Exclusion bands for receivers ..................................................................................................................... 10 4.3.2 Exclusion band for transmitters .................................................................................................................. 11 4.4 Narrow band responses of receivers ................................................................................................................. 11 4.5 Normal test modulation .................................................................................................................................... 11 5 Performance assessment ......................................................................................................................... 11 5.1 General ............................................................................................................................................................. 11 5.2 Equipment which can provide a continuous communications link .................................................................. 12 5.3 Equipment which does not provide a continuous communications link ........................................................... 12 5.4 Ancillary equipment ......................................................................................................................................... 12 5.5 Equipment's type classification ........................................................................................................................ 12 6 Performance criteria ............................................................................................................................... 12 6.1 Sub-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 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 Annex A (normative): Definitions of types of LP-AMI and LP-AMI-P devices in the scope of the present document ..................................................................................... 20 A.1 LP-AMI and LP-AMI-P devices intended for operation in the frequency range 2 483,5 MHz to 2 500 MHz .............................................................................................................................................. 20 SIST EN 301 489-35 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)4 Annex B (normative): Test fixture for LP-AMI devices (Simulated man) ..................................... 21 Annex C (informative): Bibliography ................................................................................................... 23 History .............................................................................................................................................................. 24

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)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 (http://ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This Harmonized European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been produced by ETSI in response to mandate 284 (M/284) [i.1] issued from the European Commission under Directive 98/34/EC [i.2] as amended by Directive 98/48/EC [i.8]. The title and reference to the present document are intended to be included in the publication in the Official Journal of the European Union of titles and references of Harmonized Standard under the Directive 1999/5/EC [i.3]. See article 5.1 of Directive 1999/5/EC [i.3] for information on presumption of conformity and Harmonised Standards or parts thereof the references of which have been published in the Official Journal of the European Union. The present document is part 35 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: 25 October 2013 Date of latest announcement of this EN (doa): 31 January 2014 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 July 2014 Date of withdrawal of any conflicting National Standard (dow): 31 July 2015

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)6 1 Scope The present document together with 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 A. In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and 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 EN 301 489-1 [1], except for any special conditions included in the present document. 2 References References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. Referenced documents which are not found to be publicly available in the expected location might be found at http://docbox.etsi.org/Reference. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long term validity. 2.1 Normative references The following referenced documents are necessary for the application of the present document. [1] ETSI EN 301 489-1 (V1.9.2) (09-2011): "Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements". [2] CENELEC EN 61000-4-5:2006: "Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test". [3] ETSI EN 301 559-1 (V1.1.2) (06-2012): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 1: Technical characteristics and test methods". [4] ETSI EN 301 559-2 (V1.1.2) (06-2012): "Electromagnetic compatibility and Radio spectrum Matters (ERM);Short Range Devices (SRD);Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive". SIST EN 301 489-35 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)7 2.2 Informative references 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] M/284: "Standardisation mandate to CEN, CENELEC and ETSI in the field of harmonised standards for the R&TTE Directive". [i.2] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. [i.3] Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity. [i.4] CENELEC EN 60601-1-2: "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests". [i.5] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)". [i.6] 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.7] http://niremf.ifac.cnr.it/. [i.8] Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in EN 301 489-1 [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 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)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 following abbreviations 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 R&TTE Radio and Telecommunications Terminal Equipment RF Radio Frequency SRD Short Range Devices 4 Test conditions For the purposes of the present document, the test conditions of the 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. 4.1 General 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 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)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 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 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 The provisions of the EN 301 489-1 [1], clause 4.2 shall apply. 4.2.1 Arrangements for test signals at the input of the transmitter The provisions of the 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 output of the transmitter The provisions of the 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 LP-AMI transmitters For LP-AMI transmitters the test fixture described in annex B shall be used: - The manufacturer shall provide a suitable receiver that can be used to monitor the medical implant communications link. 4.2.2.2 LP-AMI-P transmitters The provisions of 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 input of the receiver The provisions of 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; - the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant communications link. SIST EN 301 489-35 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)10 4.2.4 Arrangements for test signals at the output of the receiver The provisions of 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. 4.2.5 Arrangements for testing transmitter and receiver together (as a system: LP-AMI together with an associated LP-AMI-P) The provisions of EN 301 489-1 [1], clause 4.2.5 shall apply with the following modification: - the transmitter of an LP-AMI and the receiver of an associated LP-AMI-P or the receiver of an LP-AMI and the transmitter of an associated LP-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. 4.3 Exclusion bands 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 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. 4.3.1 Exclusion bands for receivers The exclusion band for the various categories of receivers (including receivers that are part of transceivers), as 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 centred around the centre frequency of the intended operating band, whichever is the greater. SIST EN 301 489-35 V1.1.2:2013

ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)11 Table 1: Exclusion bands for the receiver part of LP-AMIs or LP-AMI-Ps Receiver operating

Receiver category 1 Receiver category 2 Receiver category 3 2 483,5 MHz to 2 500 MHz fo ± 75 MHz fo±

4.3.2 Exclusion band for transmitters For transmitters operating, or intended to operate, in a channelized arrangement in the 2 483,5 MHz to 2 500 MHz frequency band, the exclusion band is three times the maximum occupied bandwidth allowed for that service, centred around the operating frequency. For the 2 483,5 MHz to 2 500 MHz band, the maximum occupied bandwidth is 2 MHz. The actual occupied bandwidth is determined using the procedures in EN 301 559-1 [3] for measuring emission bandwidth. For wide band transmitters, i.e. transmitters in a non-channelized frequency band, the exclusion band is twice the intended operating frequency band centred around 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 receivers or the exclusion band defined for transmitters shall be used, whichever is greater. 4.4 Narrow band responses of receivers The provision of 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 which produces specific selective messages or commands as stated by the manufacturer, representing a practical selection of usable sele