ETSI EN 301 559-1-2012 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Low Power Active Medical Implants (LP-AMI) operating in the frequenc_1.pdf

1、 ETSI EN 301 559-1 V1.1.2 (2012-06) 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 European Standard ET

2、SI ETSI EN 301 559-1 V1.1.2 (2012-06) 2Reference DEN/ERM-TG30-300 Keywords EMC, health, 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 enregistre

3、 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 contents be

4、tween 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

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6、cor/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 2012. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTMand

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8、01 559-1 V1.1.2 (2012-06) 3Contents Intellectual Property Rights 6g3Foreword . 6g3Introduction 6g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 9g33 Definitions, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 11g33.3 Abbreviations . 12g34 Technica

9、l requirements and specifications . 12g34.1 General requirements . 12g34.1.1 Transmitter requirements 12g34.1.2 Receiver requirements 12g34.2 Presentation of equipment for testing purposes 13g34.2.1 Choice of model for testing 13g34.2.2 Spurious emission testing for composite equipment . 13g34.2.3 T

10、esting of equipment with alternative power levels . 13g34.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 14g34.2.4.1 Equipment with an internal permanent or temporary antenna connector 14g34.2.4.2 Equipment with a temporary antenna connector

11、. 14g34.2.4.3 Equipment intended to be implanted in a human body . 14g34.3 Mechanical and electrical design 14g34.3.1 General 14g34.3.2 Controls 14g34.3.3 Transmitter shut-off facility 14g34.3.4 Marking 14g34.3.5 Equipment identification . 14g34.4 Declarations by the Applicant 15g34.5 Auxiliary test

12、 equipment 15g34.6 Interpretation of the measurement results 15g35 Test conditions, power sources and ambient temperatures 15g35.1 Normal and extreme test conditions . 15g35.2 Test power source . 15g35.2.1 External test power source 15g35.2.2 Internal test power source . 16g35.3 Normal test conditio

13、ns 16g35.3.1 Normal temperature and humidity 16g35.3.2 Normal test power source . 16g35.3.2.1 Mains voltage 16g35.3.2.2 Power sources . 16g35.4 Extreme test conditions 17g35.4.1 Extreme temperatures . 17g35.4.1.1 Procedure for tests at extreme temperatures 17g35.4.1.1.1 Procedure for equipment desig

14、ned for continuous operation 17g35.4.1.1.2 Procedure for equipment designed for intermittent operation . 17g35.4.1.2 Extreme temperature ranges 17g35.4.2 Extreme test source voltages . 18g35.4.2.1 Mains voltage 18g35.4.2.2 Power sources . 18g36 General conditions 18g3ETSI ETSI EN 301 559-1 V1.1.2 (2

15、012-06) 46.1 Normal test signals and test modulation . 18g36.1.1 Normal modulation test signals for data . 19g36.2 Antennas . 19g36.3 Artificial antenna 19g36.3.1 Artificial antenna for transmitters with 50 impedance connector . 19g36.4 Test fixture for LP-AMI-P 19g36.5 Test fixture for LP-AMI . 20g

16、36.6 Test sites and general arrangements for radiated measurements 20g36.7 Modes of operation of the transmitter 20g36.8 Measuring receiver . 20g37 Measurement uncertainty . 21g38 Methods of measurement and limits for transmitter parameters 22g38.1 Frequency error 22g38.1.1 Definition 22g38.1.1.1 Me

17、thod of measurement for systems with an unmodulated carrier frequency operating mode 23g38.1.1.2 Method of measurement for systems with a modulated output frequency 23g38.1.2 Limit . 23g38.2 Emission bandwidth measurement . 23g38.2.1 Definition 23g38.2.1.1 Method of measurement 23g38.2.2 Limits 24g3

18、8.3 Effective isotropic radiated power of the fundamental emission 24g38.3.1 Definition 24g38.3.1.1 Methods of measurement 24g38.3.2 Limits 25g38.4 Spurious emissions . 25g38.4.1 Definition 25g38.4.1.1 Method of measuring the effective radiated power of spurious emissions 25g38.4.2 Limits 27g38.5 Ou

19、t-of-band emissions . 27g38.5.1 Definition 27g38.5.2 Methods of measurement 27g38.5.3 Limits 27g38.6 Frequency stability under low voltage conditions 28g38.6.1 Definition 28g38.6.1.1 Method of measurement 28g38.6.2 Limits 28g38.7 LP-AMI-P with restricted duty cycle . 28g38.7.1 Definitions 28g38.7.2

20、Declaration of Duty Cycle 28g38.7.3 Limit for duty cycle and maximum number of transmissions 29g39 Methods of measurement and limits for receiver parameters . 29g39.1 Spurious radiation. 29g39.1.1 Definition 29g39.1.1.1 Method of measuring the effective radiated power of spurious radiations 29g39.1.

21、2 Limits 30g310 Requirements and Measuring Methods for Monitoring Systems . 31g310.1 Purpose . 31g310.2 General Remarks on the Measurement Configuration . 31g310.3 LBT threshold power level . 32g310.3.1 Measurement method using out-of-operating-region disturbance 32g310.3.2 Measurement method using

22、frequency administration commands . 33g310.3.3 Measurement method for LBT operation under interference condition 33g310.3.4 Results based on above test method 33g310.3.5 Limit . 33g310.4 Monitoring system bandwidth 33g310.4.1 Measurement method using out-of-operating-region disturbance 34g310.4.2 Me

23、asurement method using frequency administration commands . 34g310.4.3 Results based on above test method 34g3ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 510.5 Monitoring system scan cycle time and minimum channel monitoring period 35g310.5.1 Measurement method using out-of-operating-region disturbance 3

24、5g310.5.1.1 Scan cycle time . 35g310.5.1.2 Minimum channel monitoring period . 35g310.5.2 Measurement method using frequency administration commands . 35g310.5.3 Results based on above test method 36g310.5.3.1 Scan cycle time . 36g310.5.3.2 Minimum Channel Monitoring Period 36g310.6 Channel access b

25、ased on ambient levels relative to the calculated access LBT threshold level, PTh. 36g310.6.1 Access based on lowest ambient level above PThusing out-of-operating-region disturbance 36g310.6.2 Access based on lowest ambient level above PThusing frequency administration commands . 37g310.6.3 Results

26、based on above test method 37g310.7 Discontinuation of AMICS session if a silent period greater than or equal to 5 seconds occurs . 37g310.7.1 Measurement method 37g310.7.2 Results based on above test method 37g310.8 Use of pre-scanned alternative channel 38g310.8.1 Measurement method for alternate

27、channel selection using out-of-operating-region disturbance 38g310.8.2 Measurement method for alternate channel selection using frequency administration commands 39g310.8.3 Results based on above test method 39g3Annex A (normative): Radiated measurements 41g3A.1 Test sites and general arrangements f

28、or measurements involving the use of radiated fields . 41g3A.1.1 Outdoor test site . 41g3A.1.1.1 Standard position 41g3A.1.1.2 Equipment in close proximity to the human body but external to it . 42g3A.1.1.3 Applicative simulator 42g3A.1.1.3.1 General matters . 42g3A.1.1.3.2 Vertical Human torso simu

29、lator for LP-AMI 42g3A.1.1.3.3 Horizontal Human torso simulator for LP-AMI 43g3A.1.2 Test antenna 44g3A.1.3 Substitution antenna . 44g3A.1.4 Optional additional indoor site . 45g3A.2 Guidance on the use of radiation test sites . 46g3A.2.1 Measuring distance . 46g3A.2.2 Test antenna 46g3A.2.3 Substit

30、ution antenna . 46g3A.2.4 Artificial antenna 46g3A.2.5 Auxiliary cables 46g3A.3 Further optional alternative indoor test site using an anechoic chamber . 47g3A.3.1 Example of the construction of a shielded anechoic chamber 47g3A.3.2 Influence of parasitic reflections in anechoic chambers . 47g3A.3.3

31、 Calibration of the shielded RF anechoic chamber 48g3Annex B (informative): Bibliography . 50g3History 51g3ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 6Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining

32、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.

33、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

34、 Web server) which are, or may be, or may become, essential to the present document. Foreword This European Standard (EN) 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

35、 purposes. The present document is part 1 of a multi-part deliverable covering Low Power Active Medical Implants (LP-AMI), Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems reference document for the equipment, TR 102 655 i.8. Part 1: “Techn

36、ical characteristics and test methods“; Part 2: “Harmonized EN covering the essential requirements of article 3.2 of the R provides additional information. ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 81 Scope The present document covers, for Low Power Active Medical Implants (LP-AMI), and associated Per

37、ipherals (LP-AMI-P) used in an Active Medical Implant Communications System (AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices. The specifications contained in the present document were devel

38、oped to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential betw

39、een AMICS operating in the band or between AMICS and other primary or secondary users of the band. Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC i.7: radio parts contained the

40、rein (referred to herein as LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC i.1 (R for telecommand and telemetry to/from an LP-AMI to another LP-AMI within the human body; with or without an integral antenna; and/or with an antenna connection provi

41、ded only for the purpose of connecting an external dedicated antenna. The present document covers requirements for radiated emissions above 30 MHz. 2 References References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific re

42、ferences, only the cited version applies. For non-specific references, the latest version of the reference 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:

43、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 CISPR 16-2-3 (2010): “Specification for radio d

44、isturbance and immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements“. 2 ETSI TR 100 028 (all parts) (V1.4.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of m

45、obile radio equipment characteristics“. ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 92.2 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 Directive 1999/5/EC of t

46、he 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 System reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in a 20 MHz band within

47、2 360 MHz to 3 400 MHz“. i.9 Hartsgrove and Kraszewski: “Composition And Electrical Properties Of A Liquid That Has The Electrical Properties Of Tissue“, 1984. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply

48、: access protocol: specification for measuring natural and man-made ambient background levels for the purpose of providing a technique for spectrum access that reduces the potential for harmful interference to/from other users of the spectrum Active Medical Implant Communication Channel (AMICC): any

49、 continuous segment of spectrum that is equal to the emission bandwidth of the device with the largest bandwidth that is to participate in an AMICL session NOTE: The following type of devices for Active Medical Implant Communications Systems is covered by the present document: Frequency agile devices (i.e. having implemented LBT investigation, replacement or modification of the anatomy or of a physiological process; control of conception medical implant event: occurrence recognized by a medical implant system device that requires the immediate transm