Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Radio equipment in the frequency range 315 kHz to 600 kHz - Part 1: Technical characteristics and test methods

Develop specific standard for Ultra Low Power Animal Implantable Devices ( ULP-AID) - Animal implants  operating in the frequency range of 315-600 kHz.    This application is described in TR 102 316 (2004-03) The radio interface is defined in CEPT/ERC/Rec 70-03 , annex 12 , band c. The present document applies to transmitters and receivers of Ultra Low Power Animal Implant Devices (ULP-AID) operating in any part or all of the band from 315 kHz to 600 kHz and any associated radio apparatus transmitting in the frequency range of 315 kHz to 600 kHz including external programmers and related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation. The present document contains the technical characteristics and test methods for radio equipment and is referenced in CEPT/ERC Recommendation 70-03, annex 12 band(c). The present document does not necessarily include all the characteristics which may be required by a user, nor does it necessarily represent the optimum performance achievable. It is a product standard which may be completely or partially superseded by specific standards covering specific applications. The present document applies to ULP-AID transceivers conforming to the following:
inductive loop systems;
with an antenna connection and/or with an integral antenna;
for use as telecommunications and telecommand transmission to/from implanted animal systems.
All types of digital modulation for radio devices are covered by the present document.

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Naprave kratkega dosega (SRD) - Radijska oprema, ki deluje v frekvenčnem območju od 315 kHz do 600 kHz - 1. del: Tehnične karakteristike in preskusne metode

General Information

Status
Published
Publication Date
24-Mar-2008
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
17-Mar-2008
Due Date
22-May-2008
Completion Date
25-Mar-2008

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.YHQþQHPPHWRGHElectromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Radio equipment in the frequency range 315 kHz to 600 kHz - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipmentICS:Ta slovenski standard je istoveten z:EN 302 536-1 Version 1.1.1SIST EN 302 536-1 V1.1.1:2008en01-maj-2008SIST EN 302 536-1 V1.1.1:2008SLOVENSKI

STANDARD
SIST EN 302 536-1 V1.1.1:2008

ETSI EN 302 536-1 V1.1.1 (2007-11)European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 1: Technical characteristics and test methods

SIST EN 302 536-1 V1.1.1:2008
ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 2

Reference DEN/ERM-TG30-004-1 Keywords inductive, magnetic, SRD, testing 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

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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 2007. All rights reserved.

DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTM and the TIPHON logo are Trade Marks currently being registered by ETSI for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. SIST EN 302 536-1 V1.1.1:2008

ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 3

Contents Intellectual Property Rights................................................................................................................................6 Foreword.............................................................................................................................................................6 1 Scope........................................................................................................................................................7 2 References................................................................................................................................................7 3 Definitions, symbols and abbreviations...................................................................................................7 3.1 Definitions..........................................................................................................................................................7 3.2 Symbols..............................................................................................................................................................8 3.3 Abbreviations.....................................................................................................................................................8 4 Essential requirements and specifications................................................................................................9 4.1 General requirements.........................................................................................................................................9 4.1.1 Transmitter requirements..............................................................................................................................9 4.1.2 Receiver requirements..................................................................................................................................9 4.2 Presentation of equipment for testing purposes..................................................................................................9 4.2.1 Choice of model for testing..........................................................................................................................9 4.2.2 Testing of equipment with alternative power levels.....................................................................................9 4.2.3 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna equipment)..................................................................................................................................................10 4.2.3.1 Equipment with an internal permanent or temporary antenna connector..............................................10 4.2.3.2 Equipment with a temporary antenna connector...................................................................................10 4.2.3.3 Equipment intended to be implanted in the body..................................................................................10 4.3 Mechanical and electrical design......................................................................................................................10 4.3.1 General........................................................................................................................................................10 4.3.2 Controls......................................................................................................................................................10 4.3.3 Transmitter shut-off facility........................................................................................................................10 4.3.4 Receiver power save capability..................................................................................................................10 4.4 Declarations by the provider............................................................................................................................11 4.5 Auxiliary test equipment..................................................................................................................................11 4.6 Interpretation of the measurement results........................................................................................................11 5 Test conditions, power sources and ambient temperatures....................................................................11 5.1 Normal and extreme test conditions.................................................................................................................11 5.2 Test power source.............................................................................................................................................11 5.2.1 External test power source..........................................................................................................................11 5.2.2 Internal test power source...........................................................................................................................12 5.3 Normal test conditions......................................................................................................................................12 5.3.1 Normal temperature and humidity..............................................................................................................12 5.3.2 Normal test power source...........................................................................................................................12 5.3.2.1 Mains voltage........................................................................................................................................12 5.3.2.2 Regulated lead-acid battery power sources...........................................................................................13 5.3.2.3 Other power sources..............................................................................................................................13 5.4 Extreme test conditions....................................................................................................................................13 5.4.1 Extreme temperatures.................................................................................................................................13 5.4.1.1 Procedure for tests at extreme temperatures..........................................................................................13 5.4.1.2 Procedure for equipment designed for continuous operation................................................................13 5.4.1.3 Procedure for equipment designed for intermittent operation...............................................................13 5.4.1.4 Extreme temperature ranges..................................................................................................................14 5.4.2 Extreme test source voltages.......................................................................................................................14 5.4.2.1 Mains voltage........................................................................................................................................14 5.4.2.2 Regulated lead-acid battery power sources...........................................................................................14 5.4.2.3 Power sources using other types of batteries.........................................................................................14 5.4.2.4 Other power sources..............................................................................................................................15 6 General conditions..................................................................................................................................15 6.1 Normal test signals and test modulation...........................................................................................................15 6.1.1 Normal test signals for data........................................................................................................................15 SIST EN 302 536-1 V1.1.1:2008

ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 4

6.2 Antenna............................................................................................................................................................15 6.2.1 Artificial antenna........................................................................................................................................16 6.3 Test fixture.......................................................................................................................................................16 6.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the body............................................................................................................................................................16 6.4 Test sites and general arrangements for radiated measurements......................................................................16 6.5 Modes of operation of the transmitter..............................................................................................................17 7 Measuring receiver.................................................................................................................................17 8 Transmitter requirements.......................................................................................................................17 8.1 Transmitter definitions.....................................................................................................................................17 8.1.1 The inductive loop coil transmitters...........................................................................................................18 8.1.2 Product classes............................................................................................................................................18 8.2 Transmitter carrier output levels......................................................................................................................18 8.2.1 H-field (radiated)........................................................................................................................................18 8.2.1.1 Definition..............................................................................................................................................18 8.2.1.2 Methods of measurement......................................................................................................................19 8.2.1.3 Limits....................................................................................................................................................19 8.2.2 Radiated E-field..........................................................................................................................................19 8.2.2.1 Definition..............................................................................................................................................19 8.2.2.2 Methods of measurement......................................................................................................................19 8.2.2.3 Limits....................................................................................................................................................20 8.3 Permitted frequency range of the modulation bandwidth.................................................................................20 8.3.1 Definition....................................................................................................................................................20 8.3.2 Method of measurement.............................................................................................................................20 8.3.3 Limits..........................................................................................................................................................21 8.4 Spurious emissions...........................................................................................................................................21 8.4.1 Definition....................................................................................................................................................21 8.4.2 Radiated field strength................................................................................................................................21 8.4.2.1 Methods of measurement (< 30 MHz)..................................................................................................21 8.4.2.2 Limits....................................................................................................................................................21 8.5 Duty cycle........................................................................................................................................................21 8.5.1 Definitions..................................................................................................................................................21 8.5.2 Declaration..................................................................................................................................................22 8.5.3 Limit...........................................................................................................................................................22 9 Receiver Requirement............................................................................................................................22 9.1 Receiver spurious radiation..............................................................................................................................22 9.1.1 Definition....................................................................................................................................................22 9.1.2 Methods of measurement............................................................................................................................22 9.1.3 Limits..........................................................................................................................................................22 10 Measurement uncertainty.......................................................................................................................22 Annex A (normative): Radiated measurements................................................................................24 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.................24 A.1.1 Outdoor test site...............................................................................................................................................24 A.1.1.1 Standard position........................................................................................................................................24 A.1.1.2 Active implant equipment...........................................................................................................................25 A.1.2 Test antenna......................................................................................................................................................26 A.1.2.1 Below 30 MHz............................................................................................................................................26 A.2 Guidance on the use of radiation test sites.............................................................................................26 A.2.1 Measuring distance...........................................................................................................................................26 A.2.2 Auxiliary cables................................................................................................................................................26 Annex B (normative): H-field limit correction factor for generated E-fields.................................27 Annex C (informative): E-fields in the near field at low frequencies.................................................28 Annex D (normative): H-field measurements and limits at 3 m and 30 m.....................................29 D.1 Limits for measurements at 30 m distance.............................................................................................29 SIST EN 302 536-1 V1.1.1:2008

ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 5

D.2 Limits for measurements at 3 m distance...............................................................................................30 Annex E (informative): Bibliography...................................................................................................31 History..............................................................................................................................................................32

SIST EN 302 536-1 V1.1.1:2008
ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 6

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://webapp.etsi.org/IPR/home.asp). 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 European Standard (Telecommunications series) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). For non-EU countries the present document may be used for regulatory (Type Approval) purposes. The present document is part 1 of a multi-part deliverable covering Radio Equipment in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implant Devices and accessory peripheral systems including devices that are intended to be outside the body but in very close proximity to it in normal operation, as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".

National transposition dates Date of adoption of this EN: 19 October 2007 Date of latest announcement of this EN (doa): 31 January 2008 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 July 2008 Date of withdrawal of any conflicting National Standard (dow): 31 July 2008

SIST EN 302 536-1 V1.1.1:2008
ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 7

1 Scope The present document applies to transmitters and receivers of Ultra Low Power Animal Implant Devices (ULP-AID) operating in any part or all of the band from 315 kHz to 600 kHz and any associated radio apparatus transmitting in the frequency range of 315 kHz to 600 kHz including external programmers and related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation. The present document contains the technical characteristics and test methods for radio equipment and is referenced in CEPT/ERC Recommendation 70-03, annex 12 band(c). The present document does not necessarily include all the characteristics which may be required by a user, nor does it necessarily represent the optimum performance achievable. It is a product standard which may be completely or partially superseded by specific standards covering specific applications. The present document applies to ULP-AID transceivers conforming to the following: • inductive loop systems; • with an antenna connection and/or with an integral antenna; • for use as telecommunications and telecommand transmission to/from implanted animal systems. All types of digital modulation for radio devices are covered by the present document. 2 References The following documents contain provisions which, through reference in this text, constitute provisions of the present document. • References are either specific (identified by date of publication and/or edition number or version number) or non-specific. • For a specific reference, subsequent revisions do not apply. • For a non-specific reference, the latest version 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. [1] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [2] ETSI TR 100 028 (V1.4.1) (all parts): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Animal Implant Device: active implant that includes a transmitter, with or without an integral receiver, that operates in the ULP-AID band that is placed inside the body for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment artificial antenna: tuned reduced-radiating dummy load equal to the nominal impedance specified by the provider SIST EN 302 536-1 V1.1.1:2008

ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 8

body worn device: physiologic sensor, holter type device, or other physiological data transfer device containing a transmitter or transceiver intended to be operated in close proximity to the animal body, which has its radio antenna external to the body, and is used to sense and/or transfer, via means of radio frequency transmission, physiological parameters or system programming information conducted measurements: measurements which are made using a direct connection to the equipment under test dedicated antenna: removable antenna supplied and tested with the radio equipment that is designed as an indispensable part of the equipment H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the radio frequency field can be measured integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the equipment magnetic dipole moment: product of (Number of coil turns) × (coil area) × (coil current) NOTE: Air coils only. mobile station: equipment external to the animal body intended to provide communication capability to an active implant device placed within the body programmer/controller: ULP-AID equipment used to communicate with an active implant device radiated measurements: measurements which involve the absolute measurement of a radiated field telecommand: use of radio communication for the transmission of signals to initiate, modify or terminate functions of equipment at a distance telemetry: use of radio communication for transferring data at a distance Ultra Low Power-Animal Implant Device (ULP-AID): ultra low power animal implant transmitter operating in accordance with the provisions of annex 12, band (c), to CEPT/ERC Recommendation 70-03 3.2 Symbols For the purposes of the present document, the following symbols apply: E Electrical field strength f frequency H Magnetic field strength Hef Electric filed strength limit converted from Hf

Hf H field strength limit m magnetic dipole moment P Power R Distance t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AID Animal Implant Device EMC ElectroMagnetic Compatibility EUT Equipment Under Test FSK Frequency Shift Keying RF Radio Frequency R&TTE Radio and Telecommunications Terminal Equipment SRD Short Range Device ULP-AID Ultra Low Power - Animal Implant Device SIST EN 302 536-1 V1.1.1:2008

ETSI ETSI EN 302 536-1 V1.1.1 (2007-11) 9

4 Essential requirements and specifications 4.1 General requirements 4.1.1 Transmitter requirements

See clause 8 for requirements including measurement procedures. 4.1.2 Receiver requirements See clause 9 for requirements including measurement procedures. 4.2 Presentation of equipment for testing purposes Each equipment submitted for testing shall fulfil the requirements of the present document on all frequencies over which it is intended to operate. Compliance with this requirement shall be shown by testing on the frequency of operation in the band 315 kHz to 600 kHz. If equipment is designed to operate with different carrier powers, measurement of each transmitter parameter shall be performed at the highest power level at which the transmitter is intended to operate. Additionally, the spurious emissions shall be measured at each lower power level setting or at the low, middle, and high power settings for multilevel power control systems.

For third party testing the provider shall complete, if necessary, the appropriate application form when submitting the equipment for testing. In addition, the provider shall declare the range of operating conditions and power requirements as applicable, to establish the appropriate test conditions. Additionally, technical documentation and operating manuals, sufficient to make the test, shall be supplied for all devices operating in the frequency band 315 kHz to 600 kHz. A torso simulator and tissue substitute material for testing ULP-AID devices operating in the frequency band 315 kHz to 600 kHz may be used (see clause 6.3.1).

Measurements shall be performed, according to the present document, on samples of equipment defined in clauses 4.2 through 4.2.3.3. 4.2.1 Choice of model for testing One or more samples of each model or type of transmitter operating in the frequency band 315 kHz to 600 kHz, as appropriate for testing. Any ancillary equipment needed for testing shall be provided as requested by the testing laboratory. If equipment has several optional features, considered not to affect the RF parameters, then the tests need only to be performed on the equipment configured with that combination of features considered to be the most complex or most likely to affect the RF parameters, as proposed by the provider and agreed to by the test laboratory. 4.2.2 Testing of equipment with alternative power levels If equipment is designed to operate with different carrier powers, measurement of each transmitter parameter shall be performed at the highest power level, according to the present document, on samples of equipment defined in clause 4.2.1. Spurious emissions tests shall be performed at all power levels.

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