ETSI EN 302 195-1-2004 Electromagnetic compatibility and Radio spectrum Matters (ERM) Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Imp.pdf

1、 ETSI EN 302 195-1 V1.1.1 (2004-03)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 9 kHz to 315 kHzfor Ultra Low Power Active Medical Implants (ULP-AMI)and accessories;Part 1: Technical characteristics

2、 and test methodsETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 2 Reference DEN/ERM-TG30-001-1 Keywords health, inductive, magnetic, mobile, radio, short range, 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 Siret N 348 623 56

3、2 00017 - NAF 742 C Association but non lucratif enregistre la Sous-Prfecture 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

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6、retsi.org 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 2004. All rights reserved. DECTTM, PLUGTESTSTM and UMTSTM are Trade

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8、95-1 V1.1.1 (2004-03) 3 Contents Intellectual Property Rights6 Foreword.6 1 Scope 7 2 References 8 3 Definitions, symbols and abbreviations .8 3.1 Definitions8 3.2 Symbols9 3.3 Abbreviations .9 4 Technical requirements specifications .10 4.1 General requirements .10 4.1.1 Receiver classification 10

9、4.1.2 General performance criteria 10 4.2 Presentation of equipment for testing purposes10 4.2.1 Choice of model for testing 11 4.2.2 Testing of equipment that does not have an external 50 RF connector (integral antenna equipment) 11 4.2.2.1 Equipment with an internal permanent or temporary antenna

10、connector11 4.2.2.2 Equipment with a temporary antenna connector.11 4.3 Mechanical and electrical design11 4.3.1 General11 4.3.2 Controls 11 4.3.3 Transmitter shut-off facility11 4.3.4 Receiver power save capability 12 4.4 Declarations by the applicant .12 4.5 Auxiliary test equipment 12 4.6 Interpr

11、etation 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 source13 5.2.2 Internal test power source .13 5.3 Normal test conditions13 5.3.1 Normal temperature and hum

12、idity13 5.3.2 Normal test power source .13 5.3.2.1 Mains voltage13 5.3.2.2 Regulated lead-acid battery power sources .14 5.3.2.3 Other power sources14 5.4 Extreme test conditions 14 5.4.1 Extreme temperatures .14 5.4.1.1 Procedure for tests at extreme temperatures14 5.4.1.1.1 Procedure for equipment

13、 designed for continuous operation 14 5.4.1.1.2 Procedure for equipment designed for intermittent operation .14 5.4.1.2 Extreme temperature ranges15 5.4.2 Extreme test source voltages.15 5.4.2.1 Mains voltage15 5.4.2.2 Regulated lead-acid battery power sources .15 5.4.2.3 Power sources using other t

14、ypes of batteries.16 5.4.2.4 Other power sources16 6 General conditions16 6.1 Normal test signals and test modulation.16 6.1.1 Normal test signals for data 16 6.2 Antenna 17 6.2.1 Artificial Antenna .17 ETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 4 6.3 Test fixture .17 6.3.1 Alternate test fixture for e

15、quipment intended to be implanted within a human body.17 6.4 Test sites and general arrangements for radiated measurements 18 6.5 Modes of operation of the transmitter 18 6.6 Measuring receiver.18 7 Transmitter requirements .18 7.1 Transmitter definitions .19 7.1.1 The inductive loop coil transmitte

16、rs .19 7.1.2 Product classes19 7.2 Transmitter carrier output levels 20 7.2.1 H-field (radiated) 20 7.2.1.1 Definition 20 7.2.1.2 Methods of measurement 20 7.2.1.3 Limits 20 7.2.2 Radiated E-field 20 7.2.2.1 Definition 21 7.2.2.2 Methods of measurement 21 7.2.2.3 Limits 21 7.3 Permitted frequency ra

17、nge of the modulation bandwidth.21 7.3.1 Definition21 7.3.2 Method of measurement .21 7.3.3 Limits22 7.4 Spurious emissions.22 7.4.1 Definition22 7.4.2 Radiated field strength22 7.4.2.1 Methods of measurement ( 30 MHz) 22 7.4.2.2 Limits 23 7.5 Duty cycle 23 7.5.1 Definitions 23 7.5.2 Declaration23 7

18、.5.3 Duty cycle classes.23 8 Receiver requirement .24 8.1 Blocking or desensitization 24 8.1.1 Definition24 8.1.2 Methods of measurement24 8.1.3 Limits25 8.2 Receiver spurious radiation 25 8.2.1 Definition25 8.2.1.1 Methods of measurement 25 8.2.1.2 Limits 25 9 Measurement uncertainty .26 Annex A (n

19、ormative): Radiated measurements 27 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.27 A.1.1 Outdoor test site .27 A.1.1.1 Standard position 28 A.1.1.2 Equipment in close proximity to the human body but external to it .28 A.1.1.3 Active medical implant e

20、quipment .28 A.1.2 Test antenna30 A.1.2.1 Below 30 MHz30 A.1.3 Optional additional indoor site .30 A.2 Guidance on the use of radiation test sites .30 A.2.1 Measuring distance.30 A.2.2 Auxiliary cables31 Annex B (normative): H-field limit correction factor for generated E-fields.32 Annex C (informat

21、ive): E-fields in the near field at low frequencies.33 ETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 5 Annex D (normative): H-field measurements at other distances than 10 m.34 Annex E (informative): Bibliography.36 History 37 ETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 6 Intellectual Property Rights IPRs ess

22、ential 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 potenti

23、ally 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

24、 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 ETS

25、I 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 9 kHz to 315

26、 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, as identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R - with an antenna connection and/or with an integral antenna; - for us

27、e as telecommunications and telecommand transmission to/from active medical implants. ULP-AMI equipment has an inherent safety of human life implication, manufacturers and users are cautioned to pay particular attention to the potential for interference from other systems operating in the same or ad

28、jacent bands. The present document covers physician operated programmer/controllers transmitters (typically fixed stations), patient operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations). All types of digital modulation for radio devic

29、es are covered by the present document. The radio equipment, covered by the classification SRD is divided into several power classes based on maximum radiated field strength or output power (see table 1). The power class designation is based on CEPT/ERC Recommendation 70-03 2 and ERC Decisions. Tabl

30、e 1: Maximum radiated H-field Power Class Radiated H-field or power level 1 7 dBA/m at 10 m 2 42 dBA/m at 10 m 3 72 dBA/m at 10 m (at 9 kHz to 30 kHz, descending 3 dB/octave from 30 kHz to 135 kHz) 4 37,7 dBA/m at 10 m (at 135 kHz, descending 3 dB/octave from 135 kHz to 1 MHz) 29 dBA/m at 10 m (at 1

31、,0 MHz descending 9 dB/octave from 1 MHz to 4,642 MHz) 5 9 dBA/m at 10 m (4,642 MHz to 30 MHz) 30 dBA/m at 10 m (9 kHz to 315 kHz) ETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 8 2 References The following documents contain provisions which, through reference in this text, constitute provisions of the pre

32、sent 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 t

33、o be publicly available in the expected location might be found at http:/docbox.etsi.org/Reference. 1 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 Uncer

34、tainties in the measurement of mobile radio equipment characteristics“. 5 Air Force Technical Report AL/OE-TR-1996-0037: “Compilation of the Dielectric Properties of Body Tissues at RF and Microwave Frequencies“. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the presen

35、t document, the following terms and definitions apply: active medical implant: diagnostic or therapeutic device designed to be implanted in a human body containing a power source and capable of generating radio frequency energy within the 9 kHz to 315 kHz frequency band for the purpose of providing

36、a digital communications link artificial antenna: tuned reduced-radiating dummy load equal to the nominal impedance specified by the applicant assigned frequency: frequency within the applicable band on which the device is authorized to operate conducted measurements: measurements which are made usi

37、ng 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 that is designed as an indispensable part of the equipment fixed station: equipment inten

38、ded for use in a fixed location H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the 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

39、 dipole moment: product of (Number of coil turns) (coil area) (coil current) NOTE: Air coils only. ETSI ETSI EN 302 195-1 V1.1.1 (2004-03) 9 medical implant device: apparatus that includes a transmitter with an integral receiver that operates in the ULP-AMI band that is placed inside the human body

40、for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment medical implant programmer/control transmitter: a transmitter, operating outside of a human body in the ULP-AMI frequency band that transfers information to/from the implant after a communications link is ini

41、tiated mobile station: equipment external to the body, normally used by a patient, to provide telecommand or telemetry communication functions to a medical implant device placed within the body patient activator: equipment intended to be used by a patient to communicate with an implanted device port

42、able station: equipment intended to be carried, attached or implanted in a human body that is operated at a separation distance less than 20 cm from or internal to a human body programmer/controller: ULP-AMI equipment used by a physician to communicate with an implanted device radiated measurements:

43、 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 telecommunications: use of radio communications for the transmission of data between

44、various ULP-AMI devices telemetry: use of radio communication for indicating or recording data at a distance Ultra Low Power Active Medical Implant (ULP-AMI): active medical implant transmitter or associated medical implant programmer/control transmitter that is designed to radiate RF energy in acco

45、rdance with the provisions of annex 12, band (b), to CEPT/ERC Recommendation 70-03 2 and EN 302 195-1 3.2 Symbols For the purposes of the present document, the following symbols apply: E Electrical field strength Eo Reference electrical field strength (see annex A) f frequency H Magnetic field stren

46、gth Ho Reference magnetic field strength (see annex A) m magnetic dipole moment P PowerR Distance Ro Reference distance (see annex A) t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: EMC ElectroMagnetic Compatibility RF Radio Frequency R e.g. serv

47、ing human life inherent systems (may result in a physical risk to a person) 2 8.1 and 8.2 Medium reliable ULP-AMI communication media e.g. causing Inconvenience to persons, which cannot simply be overcome by other means 3 8.2 Standard reliable ULP-AMI communication media e.g. Inconvenience to person

48、s, which can simply be overcome by other means (e.g. manual) NOTE: In particular where an ULP-AMI which may have an inherent safety of human life implication, manufacturers and users should pay particular attention to the potential for interference from other systems operating in the same or adjacen

49、t bands. 4.1.2 General performance criteria The receiver performance shall be in conformity with the specifications declared by the manufacturer. Where the intended performance cannot be achieved under testing, the manufacturer shall declare and publish the performance criteria used to determine the performance of the receiver. 4.2 Presentation of equipment for testing purposes Each equipment submitted for testing where type approval is still in force shall fulfil the requirements of the present document on all frequencies over which it is intended to