SIST EN 301 489-35 V1.1.2:2013
(Main)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
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
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.
Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Standard elektromagnetne združljivosti (EMC) za radijsko opremo in storitve - 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 EN 301 489-1[1] vključuje oceno vseh radijskih oddajno-sprejemnih naprav, povezanih z aktivnimi medicinskimi vsadki z majhno močjo (LP-AMI) in pripadajočimi perifernimi napravami, v zvezi z elektromagnetno združljivostjo (EMC). Ta dokument zajema vse zahteve elektromagnetne združljivosti za radijske funkcije aktivnih medicinskih vsadkov z majhno močjo in pripadajočih perifernih naprav (LP-AMI-P). Ta dokument ne vključuje tehničnih specifikacij v zvezi z antenskim vhodom in sevanjem iz vhoda na ohišju radijskega sistema aktivnih medicinskih vsadkov majhne moči in pripadajočih perifernih naprav. Takšne tehnične specifikacije so navedene v ustreznih standardih za izdelek na področju učinkovite uporabe radijskega spektra. Dokument določa veljavne preskusne pogoje, oceno zmogljivosti in merila zmogljivosti za aktivne medicinske vsadke majhne moči in pripadajoče periferne naprave. Opredelitve vrst aktivnih medicinskih vsadkov in pripadajočih perifernih naprav, ki jih zajema ta dokument, so navedene v dodatku A. Če se ta dokument in standard EN 301 489-1 [1] razlikujeta (na primer glede posebnih pogojev, opredelitev in kratic), imajo prednost določbe tega dokumenta. Okoljska razvrstitev ter zahteve glede sevanja in odpornosti iz tega dokumenta so navedene v standardu EN 301 489-1 [1], razen posebnih pogojev iz tega dokumenta.
General Information
Buy Standard
Standards Content (Sample)
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
STANDARD
SIST EN 301 489-35 V1.1.2:2013
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
Harmonized European Standard SIST EN 301 489-35 V1.1.2:2013
ETSI ETSI EN 301 489-35 V1.1.2 (2013-10)2
Reference DEN/ERM-EMC-313 Keywords EMC, 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 Individual copies of the present document can be downloaded from: http://www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the 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 http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to one of the following services: http://portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2013. 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 V1.1.2:2013
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
SIST EN 301 489-35 V1.1.2:2013
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
SIST EN 301 489-35 V1.1.2:2013
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
frequency fo Receiver exclusion bands
Receiver category 1 Receiver category 2 Receiver category 3 2 483,5 MHz to 2 500 MHz fo ± 75 MHz fo±
100 MHz fo ± 300 ΜΗz
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
...
ETSI EN 301 489-35 V1.1.2 (2013-10)
Harmonized European Standard
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
---------------------- Page: 1 ----------------------
2 ETSI EN 301 489-35 V1.1.2 (2013-10)
Reference
DEN/ERM-EMC-313
Keywords
EMC, 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
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the 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
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2013.
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 V1.1.2 (2013-10)
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
ETSI
---------------------- Page: 3 ----------------------
4 ETSI EN 301 489-35 V1.1.2 (2013-10)
Annex B (normative): Test fixture for LP-AMI devices (Simulated man) . 21
Annex C (informative): Bibliography . 23
History . 24
ETSI
---------------------- Page: 4 ----------------------
5 ETSI EN 301 489-35 V1.1.2 (2013-10)
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
---------------------- Page: 5 ----------------------
6 ETSI EN 301 489-35 V1.1.2 (2013-10)
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".
ETSI
---------------------- Page: 6 ----------------------
7 ETSI EN 301 489-35 V1.1.2 (2013-10)
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".
ETSI
---------------------- Page: 7 ----------------------
8 ETSI EN 301 489-35 V1.1.2 (2013-10)
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
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
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.
ETSI
---------------------- Page: 8 ----------------------
9 ETSI EN 301 489-35 V1.1.2 (2013-10)
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.
ETSI
---------------------- Page: 9 ----------------------
10 ETSI EN 301 489-35 V1.1.2 (2013-10)
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.
ETSI
---------------------- Page: 10 ----------------------
11 ETSI EN 301 489-35 V1.1.2 (2013-10)
Table 1: Exclusion bands for the receiver part of LP-AMIs or LP-AMI-Ps
Receiver operating Receiver exclusion bands
frequency f
o
Receiver category 1 Receiver category 2 Receiver category 3
2 483,5 MHz to 2 500 MHz
f ± 75 MHz f ± 100 MHz f ± 300 ΜΗz
o o o
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 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, th
...
Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
Harmonized European Standard
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
---------------------- Page: 1 ----------------------
2 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
Reference
DEN/ERM-EMC-313
Keywords
EMC, 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
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the 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
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2013.
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 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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
ETSI
---------------------- Page: 3 ----------------------
4 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
Annex B (normative): Test fixture for LP-AMI devices (Simulated man) . 21
Annex C (informative): Bibliography . 23
History . 24
ETSI
---------------------- Page: 4 ----------------------
5 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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 final draft Harmonized European Standard (EN) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM), and is now submitted for the Vote phase of the
ETSI standards EN Approval Procedure.
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].
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
ETSI
---------------------- Page: 5 ----------------------
6 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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".
ETSI
---------------------- Page: 6 ----------------------
7 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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".
ETSI
---------------------- Page: 7 ----------------------
8 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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
operating frequency
f
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
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.
ETSI
---------------------- Page: 8 ----------------------
9 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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.
ETSI
---------------------- Page: 9 ----------------------
10 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
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.
ETSI
---------------------- Page: 10 ----------------------
11 Final draft ETSI EN 301 489-35 V1.1.2 (2013-08)
Table 1: Exclusion bands for the receiver part of LP-AMIs or LP-AMI-Ps
Receiver operating Receiver exclusion bands
frequency f
o
Receiver category 1 Receiver category 2 Receiver category 3
2 483,5 MHz to 2 500 MHz
f ± 75 MHz f ± 100 MHz f ± 300 ΜΗz
o o o
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 pr
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.