ETSI EN 301 839-1-2009 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (U_1.pdf

1、 ETSI EN 301 839-1 V1.3.1 (2009-10)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Active Medical Implants (ULP-AMI)and Peripherals (ULP-AMI-P)operating in the frequency range 402 MHz to 405 MHz;Par

2、t 1: Technical characteristics and test methodsETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 2Reference REN/ERM-TG30-263-1 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 A

3、ssociation but non 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

4、or perceived difference 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

5、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 comment to one of the following

6、 services: http:/portal.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 2009. All rights re

7、served. DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered 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 Partners. LTE is a Trade Mark of ETSI currently

8、being 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 301 839-1 V1.3.1 (2009-10) 3Contents Intellectual Property Rights 6g3Foreword . 6g3Introduction 6g31 Scope 8g32 Refe

9、rences 8g32.1 Normative references . 9g32.2 Informative references 9g33 Definitions, symbols and abbreviations . 10g33.1 Definitions 10g33.2 Symbols 12g33.3 Abbreviations . 12g34 Technical requirements and specifications . 13g34.1 General requirements . 13g34.1.1 Transmitter requirements 13g34.1.2 R

10、eceiver requirements 13g34.2 Presentation of equipment for testing purposes 13g34.2.1 Choice of model for testing 13g34.2.2 Testing of equipment with alternative power levels . 13g34.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13g34.2.3.1

11、Equipment with an internal permanent or temporary antenna connector 13g34.2.3.2 Equipment with a temporary antenna connector . 14g34.2.3.3 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

12、 facility 14g34.3.4 Marking 14g34.3.5 Equipment identification . 14g34.4 Declarations by the Applicant 14g34.5 Auxiliary test 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

13、 Test power source . 15g35.2.1 External test power source 15g35.2.2 Internal test power source . 16g35.3 Normal test conditions 16g35.3.1 Normal temperature and humidity 16g35.3.2 Normal test power source . 16g35.3.2.1 Mains voltage 16g35.3.2.2 Regulated lead-acid battery power sources . 16g35.3.2.3

14、 Other 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 designed for continuous operation 17g35.4.1.1.2 Procedure for equipment designed for intermittent operation . 17g35.4.1.

15、2 Extreme temperature ranges 18g35.4.2 Extreme test source voltages . 18g35.4.2.1 Mains voltage 18g35.4.2.2 Regulated lead-acid battery power sources . 18g35.4.2.3 Power sources using other types of batteries . 18g35.4.2.4 Other power sources 19g3ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 46 General co

16、nditions 19g36.1 Normal test signals and test modulation . 19g36.1.1 Normal modulation test signals for data . 19g36.2 Antennas . 19g36.3 Artificial antenna 19g36.3.1 Artificial antenna for transmitters with 50 impedance connector . 20g36.4 Test fixture for ULP-AMI-P . 20g36.5 Test fixture for ULP-A

17、MI 20g36.6 Test sites and general arrangements for radiated measurements 20g36.7 Modes of operation of the transmitter 21g36.8 Measuring receiver . 21g37 Measurement uncertainty . 22g38 Methods of measurement and limits for transmitter parameters 22g38.1 Frequency error 23g38.1.1 Definition 23g38.1.

18、1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode 23g38.1.1.2 Method of measurement for systems with a modulated carrier frequency 23g38.1.2 Limit . 24g38.2 Emission bandwidth measurement . 24g38.2.1 Definition 24g38.2.1.1 Method of measurement 24g38.2.2 Limi

19、ts 25g38.3 Effective radiated power of the fundamental emission 25g38.3.1 Definition 25g38.3.1.1 Methods of measurement 25g38.3.2 Limits 26g38.4 Spurious domain emissions 26g38.4.1 Definition 26g38.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26g38.4.2 Limits

20、 28g38.5 Frequency stability under low voltage conditions 28g38.5.1 Definition 28g38.5.1.1 Method of measurement 28g38.5.2 Limits 28g38.6 ULP-AMI with restricted power and duty cycle 28g38.6.1 Definitions 28g38.6.2 Declaration of Duty Cycle 28g38.6.3 Limit for duty cycle and maximum number of transm

21、issions 29g39 Methods of measurement and limits for receiver parameters . 29g39.1 Spurious domain radiation 29g39.1.1 Definition 29g39.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29g39.1.2 Limits 31g310 Requirements and Measuring Methods for Monitoring Syst

22、ems . 31g310A Purpose . 31g310B General Remarks on the Measurement Configuration . 31g310.1 LBT threshold power level . 32g310.1.1 Measurement method using out-of-operating-region disturbance 33g310.1.2 Measurement method using frequency administration commands . 33g310.1.3 Results based on above te

23、st method 33g310.1.4 Limit . 34g310.2 Monitoring system bandwidth 34g310.2.1 Measurement method using out-of-operating-region disturbance 34g310.2.2 Measurement method using frequency administration commands . 35g310.2.3 Results based on above test method 35g310.3 Monitoring system scan cycle time a

24、nd minimum channel monitoring period 35g310.3.1 Measurement method using out-of-operating-region disturbance 35g310.3.1.1 Scan cycle time . 35g310.3.1.2 Minimum channel monitoring period . 36g3ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 510.3.2 Measurement method using frequency administration commands

25、. 36g310.3.3 Results based on above test method 36g310.3.3.1 Scan cycle time . 36g310.3.3.2 Minimum Channel Monitoring Period 36g310.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh. 37g310.4.1 Access based on lowest ambient level above PThusing out

26、-of-operating-region disturbance 37g310.4.2 Access based on lowest ambient level above PThusing frequency administration commands . 37g310.4.3 Results based on above test method 38g310.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs 38g310.5.1 Measureme

27、nt method 38g310.5.2 Results based on above test method 38g310.6 Use of pre-scanned alternative channel 38g310.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance 39g310.6.2 Measurement method for alternate channel selection using frequency administration

28、 commands 40g310.6.3 Results based on above test method 40g3Annex A (normative): Radiated measurements 41g3A.1 Test sites and general arrangements for 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 proxim

29、ity to the human body but external to it . 42g3A.1.1.3 Human torso simulator for ULP-AMI 42g3A.1.2 Test antenna 43g3A.1.3 Substitution antenna . 43g3A.1.4 Optional additional indoor site . 44g3A.2 Guidance on the use of radiation test sites . 45g3A.2.1 Measuring distance . 45g3A.2.2 Test antenna 45g

30、3A.2.3 Substitution antenna . 45g3A.2.4 Artificial antenna 45g3A.2.5 Auxiliary cables 45g3A.3 Further optional alternative indoor test site using an anechoic chamber . 46g3A.3.1 Example of the construction of a shielded anechoic chamber 46g3A.3.2 Influence of parasitic reflections in anechoic chambe

31、rs . 46g3A.3.3 Calibration of the shielded RF anechoic chamber 47g3Annex B (normative): Technical performance of the spectrum analyser . 49g3Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source ERM_TG30 see URL: http:/www.etsi.org/) . 50g3Annex D (informative)

32、: Bibliography . 51g3History 52g3ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 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 an

33、d 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

34、/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, essentia

35、l 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

36、part 1 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz, as identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN

37、covering essential requirements of article 3.2 of the R provides additional information. ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 81 Scope The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (M

38、ICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of implant users. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the

39、 direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and

40、 the primary users of the band. Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to 403,8 MHz frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC i.10: radio parts contained therein (referred to herein as ULP-AMI and ULP

41、-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC i.1 (R or for telecommand and telemetry to/from an AIMD to another AIMD within the human body; with or without an integral antenna; and/or with an antenna connection provided only for the purpose of connecting an external ded

42、icated antenna. The present document covers requirements for radiated emissions above 25 MHz. 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-spec

43、ific 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 referring document; - for informative references. Referenced documents w

44、hich are not found to be publicly available in the expected location might 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. ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 92.

45、1 Normative references The following referenced documents are indispensable for the application of the present document. For dated references, only the edition cited applies. For non-specific references, the latest edition of the referenced document (including any amendments) applies. 1 CISPR 16-2-3

46、 (2003): “Specification for radio disturbance 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); Un

47、certainties in the measurement of mobile radio equipment characteristics“. 2.2 Informative references The following referenced documents are not essential to the use of the present document but they assist the user with regard to a particular subject area. For non-specific references, the latest ver

48、sion of the referenced document (including any amendments) applies. i.1 Directive 1999/5/EC of the 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 Short Range Devices (SRD); Ultra Lo

49、w Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means medical implant communication channel: any continuous segment of