ETSI EN 302 510-1-2007 Electromagnetic compatibility and Radio spectrum Matters (ERM) Radio equipment in the frequency range 30 MHz to 37 5 MHz for Ultra Low Power Active Medical M_1.pdf

1、 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 characteristic

2、s and test methodsETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 2 Reference DEN/ERM-TG30-003-1 Keywords radio, 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 348 623 562 00017 - NAF 742 C Association but non lucratif

3、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 any case of existing or perceived difference in c

4、ontents 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 doc

5、ument 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

6、.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

7、and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTMand 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 Partner

8、s. ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 3 Contents Intellectual Property Rights6 Foreword.6 1 Scope 7 2 References 7 3 Definitions, symbols and abbreviations .8 3.1 Definitions8 3.2 Symbols9 3.3 Abbreviations .9 4 Technical requirements and specifications.9 4.1 General requirements .9 4.1.1 Recei

9、ver classification 9 4.1.2 General performance criteria 10 4.2 Presentation of equipment for testing purposes10 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

10、temporary antenna 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 11 4.3.5 Marking (equipment identification)11 4.4 Auxiliary test e

11、quipment 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 source12 5.2.2 Internal test power source .12 5.3 Normal test conditions13 5.3.1 Nor

12、mal temperature and humidity13 5.3.2 Normal test power source .13 5.3.2.1 Mains voltage13 5.3.2.2 Regulated lead-acid battery power sources .13 5.3.2.3 Other power sources13 5.4 Extreme test conditions 13 5.4.1 Extreme temperatures .13 5.4.1.1 Procedure for tests at extreme temperatures13 5.4.1.1.1

13、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 ranges14 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 Powe

14、r sources using other types of batteries.15 5.4.2.4 Other power sources15 6 General conditions16 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 ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 4 6.3.1 Alter

15、nate 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 definitio

16、ns .18 7.2 Maximum effective radiated power18 7.2.1 Radiated E-field 18 7.2.2 Definition18 7.2.3 Methods of measurement18 7.2.4 Limits19 7.3 Out of Band Emissions.19 7.3.1 Definition20 7.3.2 Method of measurement .20 7.3.3 Limit .20 7.4 Unwanted Emissions in the spurious domain.20 7.4.1 Definition20

17、 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 Declaration22 7.5.3 Duty cycle limit 22 8 Receiver requirement .22 8.1 Blocking or desensitization 22 8.1.1 Definition22 8.1.2 Methods of measurement22 8.1.3 Limits23 8.2 Receiver spurious radiation 23 8.2.1

18、 Definition23 8.2.2 Methods of measurement23 8.2.3 Limits24 9 Measurement uncertainty .24 Annex A (normative): Radiated measurement26 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 gr

19、ound 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 antenna31 A.1.6 Substitution antenna .31 A.1.7 Measuring antenna .31 A.1.8 Stripline arrangement .31 A.1.8.1 General31 A.1.8.2 Description31 A.1.8.3

20、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): Tec

21、hnical performance of the spectrum analyser.35 ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 5 Annex C (informative): Bibliography.36 History 37 ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 6 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to

22、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 avai

23、lable 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 referenc

24、ed 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 (ER

25、M). 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

26、 identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R - external equipment with an antenna connection and/or with an integral antenna; - for use as telecommunications and/or telecommand transmission to/

27、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 im

28、plant 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 (identif

29、ied 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

30、 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 prima

31、ry 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 meas

32、urement 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

33、 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R e.g. serving human life inherent systems (may result in a physical risk to a person) 2 8.1 Medium reliable ULP-AMI communication media e.g. when a failure to operate causes inconvenience t

34、o persons, which cannot simply be overcome by other means 3 8.1.1 Standard reliable ULP-AMI communication media e.g. when a failure to operate causes inconvenience to persons, which can simply be overcome by other means (e.g. manual) NOTE: In particular where an ULP-AMI-M which may have an inherent

35、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 adjacent bands. 4.1.2 General performance criteria For the purpose of the receiver performance tests, the receiver shall produce an

36、appropriate output under normal conditions. Where the indicated performance cannot be achieved or if it is defined differently, 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 Th

37、e applicant shall declare the operating frequency, the range of operating conditions and power requirements in consultation with the laboratory, as applicable, to establish the appropriate test conditions. Additionally, technical documentation and operating manuals, sufficient to make the test, shal

38、l be supplied. A test fixture for equipment with an integral antenna may be supplied by the applicant (see clauses 6.3). For equipment supplied with an external antenna the applicant shall provide the antenna and a suitable test fixture as needed. In general, compliance must be shown by performing r

39、adiated electric field strength measurements. 4.2.1 Choice of model for testing The applicant shall provide one or more samples of the equipment, as appropriate for testing. Stand alone equipment shall be offered by the applicant complete with any ancillary equipment needed for testing. If an equipm

40、ent 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, as proposed by the applicant and agreed by the test laboratory. In the case of integ

41、ral or dedicated antenna equipment, if the equipment does not have an internal permanent 50 connector then it is permissible to supply a second sample of the equipment with a temporary antenna connector fitted to facilitate testing, see clause 4.2.2. 4.2.2 Testing of equipment that does not have an

42、external RF connector (integral antenna equipment) This type of equipment will normally be tested by performing radiated tests at 3 meters. For devices with very low radiated field levels, measurements may be made at closer distance and the levels extrapolated to 3 meters using an inverse linear ext

43、rapolation rate. ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 114.2.2.1 Equipment with an internal permanent or temporary antenna connector The means to access and/or implement the internal permanent or temporary antenna connector shall be stated by the applicant with the aid of a diagram. The fact that

44、use has been made of the internal antenna connection, or of a temporary connection, to facilitate measurements shall be recorded in the test report. 4.2.2.2 Equipment with a temporary antenna connector The applicant may submit one set of equipment with the normal antenna connected, to enable radiate

45、d measurements to be made. The applicant shall attend the test laboratory at the conclusion of the radiated measurements, to disconnect the antenna and fit the temporary connector if needed. The testing laboratory staff shall not connect or disconnect any temporary antenna connector. Alternatively,

46、the applicant may submit two sets of equipment to the test laboratory, one fitted with a temporary antenna connector with the antenna disconnected and another with the antenna connected. Each equipment shall be used for the appropriate tests. The applicant shall declare that the two sets of equipmen

47、t are identical in all aspects except for the antenna connector. 4.3 Mechanical and electrical design 4.3.1 General The equipment submitted by the applicant should be designed, constructed and manufactured in accordance with sound engineering practice and with the aim of minimizing harmful interfere

48、nce to other equipment and services. Transmitters and receivers may be individual or combination units. 4.3.2 Controls Those controls which, if maladjusted, might increase the interfering potentialities of the equipment shall not be easily accessible to the user. 4.3.3 Transmitter shut-off facility

49、If the transmitter is equipped with an automatic transmitter shut-off facility, it should be made inoperative for the duration of the test. 4.3.4 Receiver power save capability If the receiver is equipped with a battery-saving circuit, this circuit should be made inoperative for the duration of the tests. 4.3.5 Marking (equipment identification) The equipment shall be marked in a visible place. This marking shall be legible and durable. Where this is not possible due to physical size restrictions or factors associated with the intended functioning of the devic