ETSI EN 302 537-2016 Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz Harmonised Standard covering the_1.pdf

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1、 ETSI EN 302 537 V2.1.1 (2016-10) Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI

2、EN 302 537 V2.1.1 (2016-10) 2 Reference REN/ERM-TG30-307 Keywords harmonised standard, radio, regulation, 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 enre

3、gistre la Sous-Prfecture de Grasse (06) N 7803/88 Important notice The present document can be downloaded from: http:/www.etsi.org/standards-search 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 do

4、cument shall not be modified 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 wi

5、thin ETSI Secretariat. 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 https:/portal.etsi.org/TB/ETSIDeliverableStatus.aspx If you find errors in the pre

6、sent document, please send your comment to one of the following services: https:/portal.etsi.org/People/CommiteeSupportStaff.aspx 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 authori

7、zed by written permission of ETSI. The 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 2016. All rights reserved. DECTTM, PLUGT

8、ESTSTM, UMTSTMand the ETSI logo are Trade 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 Associatio

9、n. ETSI ETSI EN 302 537 V2.1.1 (2016-10) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 6g31 Scope 8g32 References 9g32.1 Normative references . 9g32.2 Informative references 9g33 Definitions, symbols and abbreviations . 10g33.1 Definitions 10g33.2 S

10、ymbols 12g33.3 Abbreviations . 13g34 Technical requirements specifications . 14g34.1 Environmental profile . 14g34.2 Conformance requirements 14g34.2.1 Transmitter requirements 14g34.2.1.1 Frequency error . 14g34.2.1.1.1 Definition. 14g34.2.1.1.2 Limits 14g34.2.1.1.3 Conformance . 14g34.2.1.2 Emissi

11、on bandwidth 14g34.2.1.2.1 Definition. 14g34.2.1.2.2 Limits 14g34.2.1.2.3 Conformance . 14g34.2.1.3 Effective radiated power of the fundamental emission . 15g34.2.1.3.0 General requirement 15g34.2.1.3.1 Definition. 15g34.2.1.3.2 Limits 15g34.2.1.3.3 Conformance . 15g34.2.1.4 Spurious emissions of tr

12、ansmitter . 15g34.2.1.4.0 General requirement 15g34.2.1.4.1 Definition. 16g34.2.1.4.2 Limits 16g34.2.1.4.3 Conformance . 16g34.2.1.5 Frequency stability under low voltage conditions . 16g34.2.1.5.1 Definition. 16g34.2.1.5.2 Limits 16g34.2.1.5.3 Conformance . 16g34.2.2 Receiver requirements 17g34.2.2

13、.1 Spurious radiation of receivers 17g34.2.2.1.1 Definition. 17g34.2.2.1.2 Limits 17g34.2.2.1.3 Conformance . 17g34.2.2.2 Receiver blocking . 17g34.2.2.2.1 Definition. 17g34.2.2.2.2 Limits 17g34.2.2.2.3 Conformance . 17g34.2.3 Transmitter and Receiver requirements 17g34.2.3.1 Spectrum Access . 17g34

14、.2.3.1.0 General requirements . 17g34.2.3.1.1 LBT/AFA spectrum access 18g34.2.3.1.2 Low Power Low Duty Cycle spectrum access 19g34.3 Mechanical and electrical design 19g34.3.1 General 19g3ETSI ETSI EN 302 537 V2.1.1 (2016-10) 4 4.3.2 Antennas . 19g34.3.3 Controls 19g34.3.4 Transmitter shut-off facil

15、ity 19g34.3.5 Void 20g34.3.6 Equipment identification . 20g35 Testing for compliance with technical requirements 20g35.1 Environmental conditions for testing . 20g35.1.0 General remark . 20g35.1.1 Presentation of equipment for testing purposes 20g35.1.1.0 General remark 20g35.1.1.1 Choice of model f

16、or testing . 20g35.1.1.2 Testing of equipment with alternative power levels 21g35.1.1.3 Testing of equipment that does not have an external 50 RF connector (integral antenna equipment) 21g35.1.1.3.1 Equipment with an internal permanent or temporary antenna connector 21g35.1.1.3.2 Equipment with a te

17、mporary antenna connector . 21g35.1.1.3.3 Equipment intended to be implanted in or worn on but totally external to a human body 21g35.1.2 Declarations by the provider . 21g35.1.3 Auxiliary test equipment . 21g35.1.4 Test Conditions . 21g35.1.4.1 Normal and extreme test conditions 21g35.1.4.2 Test po

18、wer source . 22g35.1.4.2.0 General remark 22g35.1.4.2.1 External test power source . 22g35.1.4.2.2 Internal test power source 22g35.1.4.3 Normal test conditions 22g35.1.4.3.1 Normal temperature and humidity . 22g35.1.4.3.2 Normal test power source 23g35.1.4.4 Extreme test conditions . 23g35.1.4.4.1

19、Extreme temperatures 23g35.1.4.4.2 Extreme test source voltages . 24g35.1.4.5 Normal test signals and test modulation 25g35.1.4.5.0 General remark 25g35.1.4.5.1 Normal modulation test signals for data 25g35.1.4.6 Antennas . 26g35.1.4.6.0 General remark 26g35.1.4.6.1 Artificial antenna . 26g35.1.4.6.

20、2 Artificial antenna for transmitters with 50 impedance connector 26g35.1.4.7 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices . 26g35.1.4.8 Test fixture for ULP-AMI and ULP-BWD . 27g35.1.4.9 Test sites and general arrangements for radiated measurements . 27g35.1.4.10 Modes of operation of

21、the transmitter . 27g35.1.4.11 Measuring receiver 27g35.2 Interpretation of the measurement results 27g35.3 Methods of measurement . 28g35.3.0 General requirement . 28g35.3.1 Frequency error . 29g35.3.1.0 General remark 29g35.3.1.1 Method of measurement for systems with an unmodulated carrier freque

22、ncy provision 29g35.3.1.2 Method of measurement for systems with a modulated carrier frequency 30g35.3.2 Emission bandwidth measurement . 30g35.3.3 Effective radiated power of the fundamental emission . 31g35.3.4 Spurious emissions of transmitter . 32g35.3.5 Frequency stability under low voltage con

23、ditions 33g35.3.6 Spurious radiation of receivers . 33g35.3.6.0 Overview . 33g35.3.6.1 Spurious radiation of receivers 33g35.3.6.2 Method of measuring the spurious radiations of receivers 33g35.3.7 Receiver blocking . 34g35.3.7.0 General remarks 34g35.3.7.1 Measurement method using out-of-operating-

24、region disturbance . 34g3ETSI ETSI EN 302 537 V2.1.1 (2016-10) 5 5.3.7.2 Measurement method using frequency administration commands . 35g35.3.7.3 Results based on the above test method 35g35.3.8 Spectrum Access . 35g35.3.8.1 LBT/AFA spectrum access . 35g35.3.8.1.0 General provisions. 35g35.3.8.1.1 L

25、BT threshold power level 36g35.3.8.1.2 Monitoring system bandwidth . 38g35.3.8.1.3 Monitoring system scan cycle time and minimum channel monitoring period . 39g35.3.8.1.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh40g35.3.8.1.5 Discontinuation of

26、 MEDS session if a silent period greater than or equal to 5 s occurs . 41g35.3.8.1.6 Use of pre-scanned alternate channel 42g35.3.8.2 Spectrum access based on low power and low duty cycle 44g35.3.8.2.0 Overview . 44g35.3.8.2.1 Methods of measurement. 44g3Annex A (normative): Relationship between the

27、 present document and the essential requirements of Directive 2014/53/EU . 46g3Annex B (normative): Radiated measurements 47g3B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 47g3B.1.1 Outdoor test site . 47g3B.1.1.0 Introduction. 47g3B.1.1.1 Standard p

28、osition 48g3B.1.1.2 Equipment in close proximity to the human body but external to it . 48g3B.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI . 48g3B.1.2 Test antenna 49g3B.1.3 Substitution antenna . 49g3B.1.4 Optional additional indoor site . 50g3B.2 Guidance on the use of radiation test sites

29、. 51g3B.2.0 Introduction 51g3B.2.1 Measuring distance . 51g3B.2.2 Test antenna 51g3B.2.3 Substitution antenna . 51g3B.2.4 Artificial antenna 51g3B.2.5 Auxiliary cables 51g3B.3 Further optional alternative indoor test site using a fully anechoic chamber . 52g3B.3.0 Introduction 52g3B.3.1 Example of t

30、he construction of a fully anechoic chamber 52g3B.3.2 Influence of parasitic reflections in fully anechoic chambers 52g3B.3.3 Calibration of the fully anechoic chamber . 53g3Annex C (normative): Technical performance of the spectrum analyser . 55g3Annex D (informative): Bibliography . 56g3History 57

31、g3ETSI ETSI EN 302 537 V2.1.1 (2016-10) 6 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

32、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 (https:/ipr.etsi.org/). Pursuant to the ETSI IPR Polic

33、y, 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 Harmo

34、nised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared under the Commissions standardisation request C(2015) 5376 final i.11 to provide one voluntary means of conforming to the

35、essential requirements of Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC i.2. Once the present document is cited in the Official Journal of the European Union under that Di

36、rective, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. National transposit

37、ion dates Date of adoption of this EN: 12 September 2016 Date of latest announcement of this EN (doa): 31 December 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e): 30 June 2017 Date of withdrawal of any conflicting National Standard (dow): 30 June 2018 Moda

38、l verbs terminology In the present document “shall“, “shall not“, “should“, “should not“, “may“, “need not“, “will“, “will not“, “can“ and “cannot“ are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). “must“ and “must not“ are N

39、OT allowed in ETSI deliverables except when used in direct citation. Introduction The present document covers the ultra low power radio devices used in a Medical Data Service and the various types of devices that form part of the system providing the service. It includes methods of measurement and r

40、equirements for radio systems used in the service that are fitted with an antenna connector and/or having an integral antenna. If a device which is operating in the MEDS and is available on the market is required to be checked, it should be tested in accordance with the methods of measurement specif

41、ied in the present document. ETSI ETSI EN 302 537 V2.1.1 (2016-10) 7 The present document covers various individual devices which when operating together form a system operating as a Medical Data Service (MEDS) that provides medical practitioners with therapeutic and/or diagnostic information used t

42、o provide improved medical treatment of a patient and/or to provide an interactive system for patient control of therapeutic devices MEDS is intended only for transmission of non-time critical data, the loss of which will not compromise the health and/or safety of the patient. The present document c

43、ontains required characteristics considered necessary for the radio sections to meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and delivering therapies to individuals with various illnesses. Of particular importance is the incl

44、usion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MEDS systems operating in the band or between a MEDS system and primary users of the band. The present document is a specific product standard applic

45、able to ultra low power devices that are part of a MEDS system operating in spectrum within the frequency bands 401 MHz to 402 MHz and 405 MHz to 406 MHz. The frequency usage conditions for the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz are European wide harmonised for “active medical implant d

46、evices“ according to Commission Implementing Decision 2013/752/EU i.12 and ERC Decision (01)17 i.1. The present document contains the technical characteristics for ultra low power radio equipment and is structured in the following way: Clauses 1 through 3 provide a general description on the types o

47、f equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides the technical requirements, specifications, limits and conformance relative to transmitter, receiver, and spectrum access. Clauses 5.1 and 5.2 specify the conditions for testing of the

48、equipment and interpretation of the measurement results with the maximum measurement uncertainty values. Clause 5.3 specifies the required measurement methods. In particular clause 5.3.8 describes the monitoring system performance specifications that have been chosen to minimize harmful interference

49、 to other equipment or services and minimize the potential for disturbance to this equipment from ambient sources or other medical device users in the band. Annex A (normative) provides the relationship between the present document and the essential requirements of Directive 2014/53/EU. Annex B (normative) provides specifications concerning radiated measurements. Annex C (normative) provides Technical performance of the spectrum analyser. Annex D (informative) bibliography provides additional information. ETSI ETSI EN 302 537 V2.1.1 (2016-10) 8 1 S