SIST EN 302 510-1 V1.1.1:2007

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQHElectromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna 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 302 510-1 Version 1.1.1SIST EN 302 510-1 V1.1.1:2007en01-december-2007SIST EN 302 510-1 V1.1.1:2007SLOVENSKI

ETSI EN 302 510-1 V1.1.1 (2007-07)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range30 MHz to 37,5 MHz for Ultra Low Power ActiveMedical Membrane Implants and Accessories;Part 1: Technical characteristics and test methods

Reference DEN/ERM-TG30-003-1 Keywords radio, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE

Siret N° 348 623 562 00017 - NAF 742 C Association à but non lucratif enregistrée à la Sous-Préfecture de Grasse (06) N° 7803/88

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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 302 510-1 V1.1.1:2007

Contents Intellectual Property Rights................................................................................................................................6 Foreword.............................................................................................................................................................6 1 Scope........................................................................................................................................................7 2 References................................................................................................................................................7 3 Definitions, symbols and abbreviations...................................................................................................8 3.1 Definitions..........................................................................................................................................................8 3.2 Symbols..............................................................................................................................................................9 3.3 Abbreviations.....................................................................................................................................................9 4 Technical requirements and specifications...............................................................................................9 4.1 General requirements.........................................................................................................................................9 4.1.1 Receiver classification..................................................................................................................................9 4.1.2 General performance criteria......................................................................................................................10 4.2 Presentation of equipment for testing purposes................................................................................................10 4.2.1 Choice of model for testing........................................................................................................................10 4.2.2 Testing of equipment that does not have an external RF connector (integral antenna equipment).............10 4.2.2.1 Equipment with an internal permanent or temporary antenna connector..............................................11 4.2.2.2 Equipment with a temporary antenna connector...................................................................................11 4.3 Mechanical and electrical design......................................................................................................................11 4.3.1 General........................................................................................................................................................11 4.3.2 Controls......................................................................................................................................................11 4.3.3 Transmitter shut-off facility........................................................................................................................11 4.3.4 Receiver power save capability..................................................................................................................11 4.3.5 Marking (equipment identification)............................................................................................................11 4.4 Auxiliary test equipment..................................................................................................................................11 4.5 Interpretation of the measurement results........................................................................................................12 5 Test conditions, power sources and ambient temperatures....................................................................12 5.1 Normal and extreme test conditions.................................................................................................................12 5.2 Test power source.............................................................................................................................................12 5.2.1 External test power source..........................................................................................................................12 5.2.2 Internal test power source...........................................................................................................................12 5.3 Normal test conditions......................................................................................................................................13 5.3.1 Normal temperature and humidity..............................................................................................................13 5.3.2 Normal test power source...........................................................................................................................13 5.3.2.1 Mains voltage........................................................................................................................................13 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 5.4.1.1.1 Procedure for equipment designed for continuous operation..........................................................14 5.4.1.1.2 Procedure for equipment designed for intermittent operation.........................................................14 5.4.1.2 Extreme temperature ranges..................................................................................................................14 5.4.2 Extreme test source voltages.......................................................................................................................15 5.4.2.1 Mains voltage........................................................................................................................................15 5.4.2.2 Regulated lead-acid battery power sources...........................................................................................15 5.4.2.3 Power sources using other types of batteries.........................................................................................15 5.4.2.4 Other power sources..............................................................................................................................15 6 General conditions..................................................................................................................................16 6.1 Normal test signals and test modulation...........................................................................................................16 6.1.1 Normal test signals for data........................................................................................................................16 6.2 Antenna............................................................................................................................................................16 6.2.1 Artificial Antenna.......................................................................................................................................16 6.3 Test fixture.......................................................................................................................................................16 SIST EN 302 510-1 V1.1.1:2007

6.3.1 Alternate test fixture for equipment adjacent to the body or intended to be implanted within a human body............................................................................................................................................................17 6.4 Test sites and general arrangements for radiated measurements......................................................................17 6.5 Modes of operation of the transmitter..............................................................................................................17 6.6 Measuring receiver...........................................................................................................................................17 7 Transmitter requirements.......................................................................................................................18 7.1 Transmitter definitions.....................................................................................................................................18 7.2 Maximum effective radiated power..................................................................................................................18 7.2.1 Radiated E-field..........................................................................................................................................18 7.2.2 Definition....................................................................................................................................................18 7.2.3 Methods of measurement............................................................................................................................18 7.2.4 Limits..........................................................................................................................................................19 7.3 Out of Band Emissions.....................................................................................................................................19 7.3.1 Definition....................................................................................................................................................20 7.3.2 Method of measurement.............................................................................................................................20 7.3.3 Limit...........................................................................................................................................................20 7.4 Unwanted Emissions in the spurious domain...................................................................................................20 7.4.1 Definition....................................................................................................................................................20 7.4.2 Method of Measurement.............................................................................................................................20 7.4.3 Limit...........................................................................................................................................................21 7.5 Duty cycle........................................................................................................................................................22 7.5.1 Definitions..................................................................................................................................................22 7.5.2 Declaration..................................................................................................................................................22 7.5.3 Duty cycle limit..........................................................................................................................................22 8 Receiver requirement.............................................................................................................................22 8.1 Blocking or desensitization..............................................................................................................................22 8.1.1 Definition....................................................................................................................................................22 8.1.2 Methods of measurement............................................................................................................................22 8.1.3 Limits..........................................................................................................................................................23 8.2 Receiver spurious radiation..............................................................................................................................23 8.2.1 Definition....................................................................................................................................................23 8.2.2 Methods of measurement............................................................................................................................23 8.2.3 Limits..........................................................................................................................................................24 9 Measurement uncertainty.......................................................................................................................24 Annex A (normative): Radiated measurement..................................................................................26 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.................26 A.1.1 Anechoic Chamber...........................................................................................................................................26 A.1.2 Anechoic chamber with a conductive ground plane.........................................................................................27 A.1.3 Open Area Test Site (OATS)...........................................................................................................................28 A.1.4 Human torso simulator for use with active medical implant membrane transmitters.......................................29 A.1.5 Test antenna......................................................................................................................................................31 A.1.6 Substitution antenna.........................................................................................................................................31 A.1.7 Measuring antenna...........................................................................................................................................31 A.1.8 Stripline arrangement.......................................................................................................................................31 A.1.8.1 General........................................................................................................................................................31 A.1.8.2 Description..................................................................................................................................................31 A.1.8.3 Calibration..................................................................................................................................................31 A.1.8.4 Mode of use................................................................................................................................................32 A.2 Guidance on the use of radiation test sites.............................................................................................32 A.2.1 Verification of the test site...............................................................................................................................32 A.2.2 Preparation of the EUT.....................................................................................................................................32 A.2.3 Power supplies to the EUT...............................................................................................................................32 A.2.4 Range length.....................................................................................................................................................32 A.2.5 Site preparation................................................................................................................................................33 A.3 Standard test position.............................................................................................................................34 Annex B (normative): Technical performance of the spectrum analyser.......................................35 SIST EN 302 510-1 V1.1.1:2007

Annex C (informative): Bibliography...................................................................................................36 History..............................................................................................................................................................37

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 inductively coupled Ultra Low Power Active Medical Implant Membrane (ULP-AMI-M) devices in the frequency range 30 MHz to 37,5 MHz, 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: 15 June 2007 Date of latest announcement of this EN (doa): 30 September 2007 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

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

1 Scope The present document applies to Ultra Low Power Active Medical membrane implant transmitters and receiver/activators operating in the range from 30 MHz to 37,5 MHz and any associated radio apparatus including patient related telecommunication devices using digital modulation techniques. An active implantable medical device (AIMD) is regulated under the AIMD Directive 90/385/EEC [4]: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the R&TTE Directive 1999/5/EC [5]. The present document applies to ULP-AMI equipment conforming to the following: - implantable membrane technology; - external equipment with an antenna connection and/or with an integral antenna; - for use as telecommunications and/or telecommand transmission to/from active medical membrane implant. The present document covers physician operated programmer/controller transmitters (typically fixed stations), patient operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations).

All types of membrane implant technology for radio devices are covered by the present document, provided the requirements of clause 7 are met. 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] "Radiofrequency Radiation Dosimetry Handbook" (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. [3] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". [4] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AMD Directive). [5] 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 (R&TTE Directive). SIST EN 302 510-1 V1.1.1:2007

3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions 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 other than that directly generated by the human body or gravity artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant blocking: a measure of the capability of the receiver to receive a wanted modulated signal without exceeding a given degradation due to the presence of an unwanted input signal at any frequencies other than those of the spurious responses in adjacent channels or bands NOTE:

See clause 8.1.1. conducted measurements: measurements which are made using a direct connection to the equipment under test custom antenna: antenna built according to manufacturers antenna design rules dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part of the equipment duty cycle: ratio of the total on time of the "message" to the total off time in any one hour period under repeated normal operation during the time measurement interval NOTE: Whether the duty cycle is fixed or random depends on how the device is triggered. See clause 7.5.1. integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the equipment medical implant membrane device (ULP-AMI-M): active medical implant device with resonant transmission capability that operates in a ULP-AMI band and is placed inside the human body for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment medical implant membrane programmer/control transmitter: transmitter, operating outside of a human body in a ULP-AMI frequency band that transmits to and receives information from a membrane implant for the purpose of determining pressure within the human body out of band emissions: emissions resulting from the modulation process that are outside the declared band NOTE: See clause 7.3.1. programmer/controller: ULP-AMI-P equipment used by a physician to communicate with an implanted device radiated E-field: E-field in the direction of maximum field strength under the specified conditions of measurement NOTE:

See clause 7.2.2. radiated measurements: measurements which involve the absolute measurement of a radiated field spurious radiations from receivers: emissions radiated from the antenna, the chassis and case of the receiver NOTE:

It is specified as the radiated power of a discrete signal. Included in this definition are modulation products that are outside the 20 dB down point on either side of the fundamental emission. See clause 8.2.1. telecommand: use of radio communication for the transmission of signals to initiate, modify or terminate functions of equipment at a distance SIST EN 302 510-1 V1.1.1:2007

telemetry: use of radio communication for indicating or recording data at a distance Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: radio part of equipment outside the human body that communicates with an ULP-AMI unwanted emissions in the spurious domain: emissions at frequencies other than those of the carrier and sidebands associated with normal test modulation NOTE:

See clause 7.4.1. 3.2 Symbols For the purposes of the present document, the following symbols apply: E Electrical field strength f frequency P Power R Distance t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AIMD

Active Implantable Medical Device AMD Active Medical Device EMC ElectroMagnetic Compatibility ERP Effective Radiated Power EUT

Equipment Under Test OATS Open Area Test Site R&TTE Radio and Telecommunications Terminal Equipment RF Radio Frequency RMS Root Mean Square SRD Short Range Device ULP-AMI Ultra Low Power Active Medical Implant ULP-AMI-M Ultra Low Power Active Medical Implant Membrane transmitter VSWR Voltage Standing Wave Ratio 4 Technical requirements and specifications 4.1 General requirements 4.1.1 Receiver classification The product family of ULP-AMI radio devices is divided into three receiver classes, see table 1, each having its own set of minimum performance criteria. This classification is based upon the impact on per