ETSI EN 303 203-1-2014 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Medical Body Area Network Systems (MBANSs) operating in the 2 483 5 .pdf

1、 ETSI EN 303 203-1 V1.1.1 (2014-11) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 1: Technical characteristics and test methods EUROPEAN STANDARD ETSI ETSI EN

2、 303 203-1 V1.1.1 (2014-11) 2Reference DEN/ERM-TG30-304 Keywords health, network, radio, SRD, system, 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 enregist

3、re la Sous-Prfecture de Grasse (06) N 7803/88 Important notice The present document can be downloaded from: http:/www.etsi.org The present document may be made available in electronic versions and/or in print. The content of any electronic and/or print versions of the present document shall not be m

4、odified without the prior written authorization of ETSI. In case of any existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat

5、. 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

6、 comment to one of the following services: http:/portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm except as authorized by written permission of ETSI. The

7、content of the PDF version shall not be modified without the written authorization of ETSI. The copyright and the foregoing restriction extend to reproduction in all media. European Telecommunications Standards Institute 2014. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTMand the ETSI logo are Tra

8、de Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI EN 303 203-1 V1.1.1 (2014-

9、11) 3Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 7g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 8g33 Definitions, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 11g33.3 Abbreviations . 11g34 Tec

10、hnical 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 12g34.2.1 Choice of model for testing 12g34.2.2 Spurious emission testing for composite equipment . 12g34.

11、2.3 Testing of equipment with alternative power levels . 13g34.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13g34.2.4.1 Equipment with an internal permanent or temporary antenna connector 13g34.2.4.2 Equipment with a temporary antenna conne

12、ctor . 13g34.3 Mechanical and electrical design 13g34.3.1 General 13g34.3.2 Controls 13g34.3.3 Transmitter shut-off facility 13g34.4 Declarations by the Applicant 13g34.5 Auxiliary test equipment 14g34.6 Interpretation of the measurement results 14g35 Test conditions, power sources and ambient tempe

13、ratures 14g35.1 Normal and extreme test conditions . 14g35.2 Test power source . 14g35.2.1 External test power source 14g35.2.2 Internal test power source . 14g35.3 Normal test conditions 15g35.3.1 Normal temperature and humidity 15g35.3.2 Normal test power source . 15g35.3.2.1 Mains voltage 15g35.3

14、.2.2 Other power sources 15g35.4 Extreme test conditions 15g35.4.1 Extreme temperatures . 15g35.4.1.1 Procedure for tests at extreme temperatures 15g35.4.1.1.1 Procedure for equipment designed for continuous operation 16g35.4.1.1.2 Procedure for equipment designed for intermittent operation . 16g35.

15、4.1.2 Extreme temperature ranges 16g35.4.2 Extreme test source voltages . 17g35.4.2.1 Mains voltage 17g35.4.2.2 Other power sources 17g36 General conditions 17g36.1 Normal test signals and test modulation . 17g3ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 46.1.1 Normal modulation test signals for data .

16、17g36.2 Antennas . 17g36.3 Test fixture . 17g36.4 Test sites and general arrangements for radiated measurements 18g36.5 Modes of operation of the transmitter 18g36.6 Measuring receiver . 18g37 Measurement uncertainty . 19g38 Methods of measurement and limits for transmitter parameters 20g38.1 Freque

17、ncy error 20g38.1.1 Definition 20g38.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode 20g38.1.1.2 Method of measurement for systems with a modulated output frequency 21g38.1.2 Limits 21g38.2 Emission bandwidth measurement . 21g38.2.1 Definition 21g38.2.1.1

18、 Method of measurement 21g38.2.2 Limits 22g38.3 Effective isotropic radiated power of the fundamental emission 22g38.3.1 Definition 22g38.3.1.1 Methods of measurement 22g38.3.2 Limits 23g38.4 Spurious emissions . 23g38.4.1 Definition 23g38.4.1.1 Method of measuring the effective radiated power of sp

19、urious emissions 23g38.4.2 Limits 25g38.5 Out-of-band emissions . 25g38.5.1 Definition 25g38.5.2 Methods of measurement 25g38.5.3 Limits 27g38.6 Frequency stability under low voltage conditions 27g38.6.1 Definition 27g38.6.1.1 Method of measurement 27g38.6.2 Limits 27g38.7 MBANS with restricted duty

20、 cycle 27g38.7.1 Definitions 27g38.7.2 Declaration of Duty Cycle 28g38.7.3 Limit for duty cycle and maximum number of transmissions 28g39 Methods of measurement and limits for receiver parameters . 28g39.1 Spurious radiation. 28g39.1.1 Definition 28g39.1.1.1 Method of measuring the effective radiate

21、d power of spurious radiations 28g39.1.2 Limits 29g310 Requirements and Measuring Methods for Monitoring Systems . 30g310.1 Purpose . 30g310.2 General Remarks on the Measurement Configuration . 30g310.3 Adaptive Frequency Agility . 30g310.4 LBT threshold power level . 32g310.4.1 Measurement method u

22、sing frequency administration commands . 32g310.4.2 Results based on above test method 32g310.4.3 Limit . 32g310.5 Monitoring system bandwidth 32g310.6 Minimum channel monitoring period . 32g310.6.1 Measurement method using frequency administration commands . 33g310.6.2 Results based on above test m

23、ethod 33g310.6.3 Limit . 33g310.7 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh33g310.7.1 Accessing an unoccupied channel. 33g310.7.2 Results accessing an unoccupied channel . 34g310.7.3 Accessing the Least Interfered Channel 34g3ETSI ETSI EN 303 2

24、03-1 V1.1.1 (2014-11) 510.7.4 Results accessing the LIC . 34g310.7.5 Limits 34g3Annex A (normative): Radiated measurements 35g3A.1 Test sites and arrangements for radiated measurements 35g3A.1.1 Outdoor test site . 35g3A.1.2 Indoor test site 35g3A.1.3 Shielded anechoic test site 36g3A.2 Antennas . 3

25、8g3A.2.1 Test antenna 38g3A.2.2 Substitution antenna . 38g3A.3 Test practice and auxiliary test equipment . 39g3A.3.1 Measuring distance . 39g3A.3.2 Auxiliary cables 39g3Annex B (informative): Change History 40g3Annex C (informative): Bibliography . 41g3History 42g3ETSI ETSI EN 303 203-1 V1.1.1 (201

26、4-11) 6Intellectual 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 P

27、roperty 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:/ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR se

28、arches, 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 (EN) has been produced b

29、y ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document is part 1 of a multi-part deliverable covering Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document fo

30、r the equipment, TR 101 557 i.1, and as identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN covering the essential requirements of article 3.2 of the R Uncertainties in the measurement of mobile radio equipment characteristics“. 2.2 Informative references T

31、he 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 ETSI TR 101 557: “Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference document (SRdoc); Medical Body Are

32、a Network Systems (MBANSs) in the 1 785 MHz to 2 500 MHz range“. ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 9i.2 CEPT/ERC/REC 70-03: “Relating to the use of Short Range Devices (SRD)“. i.3 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommu

33、nications terminal equipment and the mutual recognition of their conformity (R A guide to the production of Harmonized Standards for application under the R investigation, replacement or modification of the anatomy or of a physiological process; control of conception. medical sensor: medical device

34、responsible for the collection of physiological parameters for diagnostic and/or therapeutic purposes monitoring system: circuitry that assures conformity with the spectrum access protocol requirements based on Listen Before Talk, Adaptive Frequency Agility and selection of the Least Interfered Chan

35、nel for operation (LIC) or the unoccupied sub-band or channel out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission bandwidth, which result from the modulation process, but excluding emissions in the spurious domain Power Spectral Density (PSD): am

36、ount of the total power inside the measuring receiver bandwidth expressed in dBm/Hz ETSI ETSI EN 303 203-1 V1.1.1 (2014-11) 11spurious domain emissions: emissions at frequencies separated by more than 250 % of the occupied bandwidth from the centre of the occupied spectrum spurious radiations from t

37、he receiver: components at any frequency, generated and radiated by active receiver circuitry and the antenna NOTE: See clause 9.1.1. talk mode: transmission of intentional radiation by a transmitter 3.2 Symbols For the purposes of the present document, the following symbols apply: B emission bandwi

38、dth dB decibeldBm absolute power level referred to one milliwatt e.i.r.p. effective isotropically radiated power f frequency fcchannel centre frequency fe frequency under extreme conditions G Antenna GainP power ppm parts per million R distance PThmaximum threshold power level (see clause 10) T temp

39、erature t time wavelength (lambda) 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AC Alternating Current AFA Adaptive Frequency Agility BW Bandwidth CW Continuous Wave DC Direct CurrentDUT Device Under Test EMC ElectroMagnetic Compatibility EUT Equipme

40、nt Under Test LBT Listen Before Talk LIC Least Interfered Channel MBANS Medical Body Area Network System MCU Micro Controller Unit PSD Power Spectral Density r.m.s. root mean square RBW Resolution BandWidth RF Radio Frequency SRD Short Range Device VSWR Voltage Standing Wave Ratio ETSI ETSI EN 303 2

41、03-1 V1.1.1 (2014-11) 124 Technical requirements and specifications 4.1 General requirements 4.1.1 Transmitter requirements See clause 8 for transmitter requirements. 4.1.2 Receiver requirements See clause 9 for receiver requirements. 4.2 Presentation of equipment for testing purposes Each equipment

42、 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 should be shown by testing each unit on a frequency near 2 490 MHz according to its intended function. The provider shall declare the

43、 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 MBANS devices. Measurements shall be performed, according to the pre

44、sent document, on samples of equipment defined in clause 4.2. The physical arrangement used for the testing shall be fully documented in the test report. 4.2.1 Choice of model for testing The provider shall supply one or more samples of each model or type of transmitter, as appropriate for testing.

45、Any ancillary equipment needed for testing shall be provided as requested by the testing laboratory. Depending on its intended use, MBANS equipment shall operate in either healthcare facility mode or home mode. The provider shall declare whether the MBANS equipment supports operation in healthcare f

46、acility mode, home mode, or both modes. The transmitter parameter tests according to clause 8 shall be carried out in all supported modes, as declared by the provider. Different test limits may be applicable for healthcare facility mode and home mode. If an equipment has several optional features, c

47、onsidered 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, agreed to by the test laboratory and recorded i

48、n the test report. 4.2.2 Spurious emission testing for composite equipment A composite equipment consisting of an MBANS transmitter and a specific type of host equipment such as a computer for digital data recovery or programming/controlling the MBANS device should be tested according to the followi

49、ng requirements. For emission tests, the most appropriate EMC standard shall be applied to the non-radio part of the host equipment. The emissions requirements in the applicable clauses of the present document apply only to the MBANS radio part of the composite equipment. In the case where the radio device is integrated and cannot operate independently, emissions from the non-radio part shall be tested with the radio part disabled. With the radio operating in transmit, receive and standby (if applicable) modes, the emission requirements of the present document sh