ETSI EN 302 537-1-2007 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Ultra Low Power Medical Data Service Systems operating in the freque.pdf

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1、 ETSI EN 302 537-1 V1.1.2 (2007-12)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Medical Data Service Systemsoperating in the frequency range401 MHz to 402 MHz and 405 MHz to 406 MHz;Part 1: Techn

2、ical characteristics andtest methodsETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 2 Reference DEN/ERM-TG30-005-1 Keywords health, SRD 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

3、 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 any case of existing or perceived diffe

4、rence in contents 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 th

5、at 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 comment to one of the following services: http:/p

6、ortal.etsi.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, PL

7、UGTESTSTM 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 Organization

8、al Partners. ETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 3 Contents Intellectual Property Rights6 Foreword.6 Introduction 7 1 Scope 8 2 References 9 2.1 Normative references .9 2.2 Informative references9 3 Definitions, symbols and abbreviations .10 3.1 Definitions10 3.2 Symbols12 3.3 Abbreviations .13

9、4 Technical requirements and specifications.13 4.1 General requirements .13 4.1.1 Transmitter requirements13 4.1.2 Receiver requirements 13 4.1.3 Spectrum access requirements 13 4.2 Presentation of equipment for testing purposes13 4.2.1 Choice of model for testing 14 4.2.2 Testing of equipment with

10、alternative power levels .14 4.2.3 Testing of equipment that does not have an external 50 RF connector (integral antenna equipment) 14 4.2.3.1 Equipment with an internal permanent or temporary antenna connector14 4.2.3.2 Equipment with a temporary antenna connector.14 4.2.3.3 Equipment intended to b

11、e implanted in or worn on but totally external to a human body15 4.3 Mechanical and electrical design15 4.3.1 General15 4.3.2 Controls 15 4.3.3 Transmitter shut-off facility15 4.3.4 Marking 15 4.3.5 Equipment identification.15 4.4 Declarations by the provider 15 4.5 Auxiliary test equipment 15 4.6 I

12、nterpretation of the measurement results 16 5 Test conditions, power sources and ambient temperatures 16 5.1 Normal and extreme test conditions .16 5.2 Test power source.16 5.2.1 External test power source16 5.2.2 Internal test power source .17 5.3 Normal test conditions17 5.3.1 Normal temperature a

13、nd humidity17 5.3.2 Normal test power source .17 5.3.2.1 Mains voltage17 5.3.2.2 Regulated lead-acid battery power sources .17 5.3.2.3 Other power sources17 5.4 Extreme test conditions 18 5.4.1 Extreme temperatures .18 5.4.1.1 Procedure for tests at extreme temperatures18 5.4.1.1.1 Procedure for equ

14、ipment designed for continuous operation 18 5.4.1.1.2 Procedure for equipment designed for intermittent operation .18 5.4.1.2 Extreme temperature ranges19 5.4.2 Extreme test source voltages.19 5.4.2.1 Mains voltage19 5.4.2.2 Regulated lead-acid battery power sources .19 ETSI ETSI EN 302 537-1 V1.1.2

15、 (2007-12) 4 5.4.2.3 Power sources using other types of batteries.19 5.4.2.4 Other power sources20 6 General conditions20 6.1 Normal test signals and test modulation.20 6.1.1 Normal modulation test signals for data .20 6.2 Antennas.20 6.3 Artificial antenna20 6.3.1 Artificial antenna for transmitter

16、s with 50 impedance connector.20 6.4 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices 21 6.5 Test fixture for ULP-AMI and ULP-BWD 21 6.6 Test sites and general arrangements for radiated measurements 21 6.7 Modes of operation of the transmitter 22 6.8 Measuring receiver.22 7 Measurement unce

17、rtainty .22 8 Methods of measurement and limits for transmitter parameters 23 8.1 Frequency error 23 8.1.1 Definition24 8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency provision24 8.1.1.2 Method of measurement for systems with a modulated carrier frequency24 8.1.2 Lim

18、it .24 8.2 Emission bandwidth measurement .25 8.2.1 Definition25 8.2.1.1 Method of measurement25 8.2.2 Limits25 8.3 Effective radiated power of the fundamental emission 25 8.3.1 Definition26 8.3.1.1 Methods of measurement 26 8.3.2 Limit as a function of spectrum access method 26 8.3.2.1 Limit for sy

19、stems using LBT and AFA for spectrum access 27 8.3.2.2 Limit for devices using low duty cycle and low power for spectrum access 27 8.4 Spurious emissions.27 8.4.1 Definition27 8.4.1.1 Method of measuring the effective radiated power of spurious emissions27 8.4.2 Limits28 8.5 Frequency stability unde

20、r low voltage conditions 28 8.5.1 Definition28 8.5.1.1 Method of measurement28 8.5.2 Limits29 8.6 Spectrum access based on low power and low duty cycle .29 8.6.1 Definition29 8.6.1.1 Methods of measurement 29 8.6.2 Limits30 8.6.2.1 Duty cycle limit.30 8.6.2.2 Repetitive transmission within an hour.3

21、0 9 Methods of measurement and limits for receiver parameters.30 9.1 Spurious radiation.30 9.1.1 Definition31 9.1.1.1 Method of measuring the effective radiated power of spurious radiations31 9.1.2 Limits31 10 Requirements for spectrum access and measuring methods for monitoring systems using LBT an

22、d AFA32 10.1 Purpose.32 10.2 LBT threshold power level.32 10.2.1 Measurement method using out-of-operating-region interference33 10.2.2 Measurement method using frequency administration commands .34 10.2.3 Results based on above test method34 10.3 Monitoring system bandwidth34 10.3.1 Measurement met

23、hod using out-of-operating-region interference34 ETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 5 10.3.2 Measurement method using frequency administration commands .35 10.3.3 Results based on above test method35 10.4 Monitoring system scan cycle time and minimum channel monitoring period35 10.4.1 Measureme

24、nt method using out-of-operating-region interference35 10.4.1.1 Scan cycle time .35 10.4.1.2 Minimum channel monitoring period .36 10.4.2 Measurement method using frequency administration commands .36 10.4.3 Results based on above test method36 10.4.3.1 Scan cycle time .36 10.4.3.2 Minimum Channel M

25、onitoring Period37 10.5 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh.37 10.5.1 Access based on lowest ambient level above PThusing out-of-operating-region interference37 10.5.2 Access based on lowest ambient level above PThusing frequency administ

26、ration commands .38 10.5.3 Results based on above test method38 10.6 Discontinuation of MEDS session if a silent period greater than or equal to 5 s occurs 38 10.6.1 Measurement method38 10.6.2 Results based on above test method38 10.7 Use of pre-scanned alternate channel .39 10.7.1 Measurement meth

27、od for alternate channel selection using out-of-operating-region interference.39 10.7.2 Measurement method for alternate channel selection using frequency administration commands 40 10.7.3 Results based on above test method40 Annex A (normative): Radiated measurements 42 A.1 Test sites and general a

28、rrangements for measurements involving the use of radiated fields.42 A.1.1 Outdoor test site .42 A.1.1.1 Standard position 43 A.1.1.2 Equipment in close proximity to the human body but external to it .43 A.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI.43 A.1.2 Test antenna44 A.1.3 Substitution

29、 antenna .44 A.1.4 Optional additional indoor site .45 A.2 Guidance on the use of radiation test sites .45 A.2.1 Measuring distance.46 A.2.2 Test antenna46 A.2.3 Substitution antenna .46 A.2.4 Artificial antenna46 A.2.5 Auxiliary cables46 A.3 Further optional alternative indoor test site using a ful

30、ly anechoic chamber.46 A.3.1 Example of the construction of a fully anechoic chamber47 A.3.2 Influence of parasitic reflections in fully anechoic chambers 47 A.3.3 Calibration of the fully anechoic chamber .47 Annex B (normative): Technical performance of the spectrum analyser.50 Annex C (informativ

31、e): Bibliography.51 History 52 ETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 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

32、 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. Latest updates are available on the ETSI Web server (http:/webapp.etsi.org/

33、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 referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential

34、 to the present document. Foreword This European Standard (Telecommunications series) 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 purposes. The present document is p

35、art 1 of a multi-part deliverable covering radio equipment in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz for Ultra Low Power Active Medical Devices and implants. This includes Body Worn, Hand-Held, Data systems, etc., the medical section of which is regulated under the Medical Dev

36、ice Directive 10 and Active Medical Implants and Peripherals the medical section of which is regulated under the Active Implantable Medical Device Directive 11 and the radio part of which are regulated under the R Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R provide

37、s additional information. ETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 8 1 Scope 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

38、 used to 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. Devices covere

39、d by the present document are an evolving new technology to be made available worldwide by the medical equipment industry that will provide high speed communications capability between devices associated with an individual patient that are part of a complete MEDS system as defined in clause 3.1. Exa

40、mples of MEDS devices falling under the scope of the present document are portable body worn physiological sensors that allow ambulatory monitoring, implanted devices and external system devices used to transfer data collected by a MEDS system to medical practitioners who will use the data to diagno

41、se and/or treat a patient. These devices utilize ultra low power radio transmitters in combination with medical devices, the medical portion of which is regulated by the Medical Device Directive (MDD) 10 or the Active Implantable Medical Device Directive (AIMD) 11. The radio part of medical devices

42、regulated by the MDD is hereafter referred to as ULP-AMD, ULP-AMD-P for peripheral devices, and ULP-BWD for body worn devices. ULP-BWD are devices, such as a physiological parameter sensors or handheld devices that are intended to operate in very close proximity to the human body, including touching

43、 the body, the radio antenna of which is external to the body and is used to communicate with a device that is part of a MEDS system. The radio part of medical devices regulated under the AIMD is hereafter referred to as Ultra Low Power-Active Medical Implants (ULP-AMI) and peripherals (ULP-AMI-P) u

44、sed in a Medical Data Service (MEDS). The present document contains 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

45、with various illnesses. Of particular importance is the inclusion 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 the primary users of the

46、band. The present document is a specific product standard applicable to ultra low power transmitters that are part of a system used in the MEDS operating in spectrum within the frequency bands 401 MHz to 402 MHz and 405 MHz to 406 MHz. The present document contains the technical characteristics for

47、ultra low power radio equipment and is addressed by CEPT/ERC/REC 70-03 9 and annex 12 to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. It applies to ultra low power system

48、s and accessories operating in spectrum within the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz that operate in the MEDS service: for telecommand and telemetry between any devices that are part of a MEDS (see definition of MEDS); with or without an integral antenna; and/or; with an antenna connec

49、tion provided only for the purpose of connecting an external dedicated antenna. ETSI ETSI EN 302 537-1 V1.1.2 (2007-12) 9 2 References 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. Non-specific reference may be made only to a complete document or a part thereof and only in the following cases: - if it is accepted that it will be possible to use all future changes of the referenced document for the purposes of the refer