ETSI EN 301 559-2016 Short Range Devices (SRD) Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the 2 483 5 MHz to 2 500 MHz range Harm.pdf

1、 ETSI EN 301 559 V2.1.1 (2016-10) Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

2、HARMONISED EUROPEAN STANDARD ETSI ETSI EN 301 559 V2.1.1 (2016-10) 2 Reference REN/ERM-TG30-314 Keywords harmonised standard, health, radio, regulation, 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

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7、cluding photocopying and microfilm except as authorized 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 Standard

8、s Institute 2016. All rights reserved. DECTTM, PLUGTESTSTM, 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 Tr

9、ade Marks registered and owned by the GSM Association. ETSI ETSI EN 301 559 V2.1.1 (2016-10) 3 Contents Intellectual Property Rights 7g3Foreword . 7g3Modal verbs terminology 7g3Introduction 8g31 Scope 9g32 References 10g32.1 Normative references . 10g32.2 Informative references 10g33 Definitions, sy

10、mbols and abbreviations . 11g33.1 Definitions 11g33.2 Symbols 13g33.3 Abbreviations . 14g34 Technical requirements and 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.

11、1.2 Limits 14g34.2.1.1.3 Conformance . 15g34.2.1.2 Emission bandwidth 15g34.2.1.2.1 Definition. 15g34.2.1.2.2 Limits 15g34.2.1.2.3 Conformance . 15g34.2.1.3 Effective isotropic radiated power of the fundamental emission 15g34.2.1.3.1 Definition. 15g34.2.1.3.2 Limits 15g34.2.1.3.3 Conformance . 15g34

12、.2.1.4 Spurious emissions 15g34.2.1.4.1 Definition. 15g34.2.1.4.2 Limits 15g34.2.1.4.3 Conformance . 16g34.2.1.5 Out-of-band emissions 16g34.2.1.5.1 Definition. 16g34.2.1.5.2 Limits 16g34.2.1.5.3 Conformance . 16g34.2.1.6 Frequency stability under low voltage conditions . 16g34.2.1.6.0 Applicability

13、 16g34.2.1.6.1 Definition. 16g34.2.1.6.2 Limits 17g34.2.1.6.3 Conformance . 17g34.2.1.7 LP-AMI-P with restricted duty cycle 17g34.2.1.7.0 General remarks. 17g34.2.1.7.1 Definition. 17g34.2.1.7.2 Limits 17g34.2.1.7.3 Conformance . 17g34.2.2 Receiver requirements 17g34.2.2.1 Spurious radiation . 17g34

14、.2.2.1.0 General provision 17g34.2.2.1.1 Definition. 17g34.2.2.1.2 Limits 18g34.2.2.1.3 Conformance . 18g34.2.2.2 Receiver blocking . 18g34.2.2.2.1 Definition. 18g3ETSI ETSI EN 301 559 V2.1.1 (2016-10) 4 4.2.2.2.2 Limits 18g34.2.2.2.3 Conformance . 18g34.2.3 Spectrum access 18g34.2.3.0 General requi

15、rements 18g34.2.3.1 LBT threshold power level 19g34.2.3.1.1 Definition. 19g34.2.3.1.2 Limits 19g34.2.3.1.3 Conformance . 19g34.2.3.2 Monitoring system bandwidth . 19g34.2.3.2.0 General remarks. 19g34.2.3.2.1 Definition. 19g34.2.3.2.2 Limits 19g34.2.3.2.3 Conformance . 20g34.2.3.3 Minimum channel mon

16、itoring period . 20g34.2.3.3.0 General remarks. 20g34.2.3.3.1 Definition. 20g34.2.3.3.2 Limits 20g34.2.3.3.3 Conformance . 20g34.2.3.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh20g34.2.3.4.0 General requirements . 20g34.2.3.4.1 Conformance . 20g

17、34.3 Mechanical and electrical design 20g34.3.1 General 20g34.3.2 Controls 21g34.3.3 Transmitter shut-off facility 21g34.3.4 Void 21g34.3.5 Equipment identification . 21g35 Testing for compliance with technical requirements 21g35.1 Environmental conditions for testing . 21g35.1.0 General requirement

18、s 21g35.1.1 Presentation of equipment for testing purposes 21g35.1.1.0 General provisions 21g35.1.1.1 Choice of model for testing . 21g35.1.1.2 Spurious emission testing for composite equipment . 22g35.1.1.3 Testing of equipment with alternative power levels 22g35.1.1.4 Presentation of equipment tha

19、t does not have an external RF connector (integral antenna equipment) . .22g35.1.1.4.1 Equipment with an internal permanent or temporary antenna connector 22g35.1.1.4.2 Equipment with a temporary antenna connector . 22g35.1.1.4.3 Equipment intended to be implanted in a human body 23g35.1.2 Declarati

20、ons by the applicant 23g35.1.3 Auxiliary test equipment . 23g35.1.4 Test conditions 23g35.1.4.1 Normal and extreme test conditions 23g35.1.4.2 Test power source . 23g35.1.4.2.0 General requirements . 23g35.1.4.2.1 External test power source . 23g35.1.4.2.2 Internal test power source 23g35.1.4.3 Norm

21、al test conditions 24g35.1.4.3.1 Normal temperature and humidity . 24g35.1.4.3.2 Normal test power source 24g35.1.4.3.2.1 Mains voltage . 24g35.1.4.3.2.2 Other power sources 24g35.1.4.4 Extreme test conditions . 24g35.1.4.4.1 Extreme temperatures 24g35.1.4.4.2 Extreme test source voltages . 26g35.1.

22、4.5 Normal test signals and test modulation 26g35.1.4.5.0 General requirements . 26g35.1.4.5.1 Normal modulation test signals for data 26g35.1.4.6 Antennas . 26g35.1.4.7 Artificial Antennas 26g3ETSI ETSI EN 301 559 V2.1.1 (2016-10) 5 5.1.4.8 Artificial antenna for transmitters with 50 impedance conn

23、ector . 26g35.1.4.9 Test fixture for LP-AMI-P 27g35.1.4.10 Test fixture for LP-AMI 27g35.1.4.11 Test sites and general arrangements for radiated measurements . 27g35.1.4.12 Modes of operation of the transmitter . 27g35.1.4.13 Measuring receiver 28g35.2 Interpretation of the measurement results 28g35

24、.3 Methods of measurement . 29g35.3.1 Methods of measurement for transmitters 29g35.3.1.0 General provision 29g35.3.1.1 Frequency error . 30g35.3.1.1.0 General requirements . 30g35.3.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode 30g35.3.1.1.2 Method of

25、measurement for systems with a modulated output frequency 30g35.3.1.2 Emission bandwidth 30g35.3.1.3 Effective isotropic radiated power of the fundamental emission 31g35.3.1.4 Transmitter spurious emissions . 32g35.3.1.5 Out-of-band emissions 33g35.3.1.6 Frequency stability under low voltage conditi

26、ons . 34g35.3.2 Methods of measurement for receivers . 34g35.3.2.0 General provisions 34g35.3.2.1 Receiver spurious emissions . 34g35.3.2.1 Receiver Blocking . 34g35.3.2.1.0 General remarks. 34g35.3.2.1.1 Measurement method using frequency administration commands 35g35.3.2.1.2 Results based on the a

27、bove test method 35g35.3.3 Methods of measurement for Monitoring Systems . 35g35.3.3.0 Purpose 35g35.3.3.1 General Remarks on the Measurement Configuration 36g35.3.3.2 LBT threshold power level 36g35.3.3.2.0 General Remarks . 36g35.3.3.2.1 Measurement method using out-of-operating-region disturbance

28、 . 36g35.3.3.2.2 Measurement method using frequency administration commands 37g35.3.3.2.3 Measurement method for LBT operation under interference condition 37g35.3.3.2.3 Results based on above test method 37g35.3.3.3 Monitoring system bandwidth . 37g35.3.3.3.0 General Remarks . 37g35.3.3.3.1 Measure

29、ment method using out-of-operating-region disturbance . 38g35.3.3.3.2 Measurement method using frequency administration commands 38g35.3.3.3.3 Results based on above test method 38g35.3.3.4 Monitoring system scan cycle time and minimum channel monitoring period . 39g35.3.3.4.0 General Remarks . 39g3

30、5.3.3.4.1 Measurement method using out-of-operating-region disturbance . 39g3Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 44g3Annex B (normative): Radiated measurements 45g3B.1 Test sites and general arrangements for measurem

31、ents involving the use of radiated fields . 45g3B.1.1 Outdoor test site . 45g3B.1.1.0 General requirement . 45g3B.1.1.1 Standard position 45g3B.1.1.2 Equipment in close proximity to the human body but external to it . 46g3B.1.1.3 Applicative simulator 46g3B.1.1.3.1 General matters . 46g3B.1.1.3.2 Ve

32、rtical Human torso simulator for LP-AMI 46g3B.1.1.3.3 Horizontal Human torso simulator for LP-AMI 47g3B.1.2 Test antenna 48g3B.1.3 Substitution antenna . 48g3B.1.4 Optional additional indoor site . 49g3ETSI ETSI EN 301 559 V2.1.1 (2016-10) 6 B.2 Guidance on the use of radiation test sites . 50g3B.2.

33、0 General requirement . 50g3B.2.1 Measuring distance . 50g3B.2.2 Test antenna 50g3B.2.3 Substitution antenna . 50g3B.2.4 Artificial antenna 50g3B.2.5 Auxiliary cables 50g3B.3 Further optional alternative indoor test site using an anechoic chamber . 51g3B.3.0 General requirements . 51g3B.3.1 Example

34、of the construction of a shielded anechoic chamber 51g3B.3.2 Influence of parasitic reflections in anechoic chambers . 51g3B.3.3 Calibration of the shielded RF anechoic chamber 52g3Annex C (informative): Bibliography . 54g3History 55g3ETSI ETSI EN 301 559 V2.1.1 (2016-10) 7 Intellectual Property Rig

35、hts 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 Property Rights (IPRs); Essential

36、, 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 Policy, no investigation, including IPR searches, has been carried out b

37、y 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 Harmonised European Standard (EN) has been produced by ETSI Technical Co

38、mmittee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared under the Commissions standardisation request C(2015) 5376 final i.12 to provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation

39、 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.1. Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of the present docum

40、ent 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. The present document covers Low Power Active Medical Implants (LP-AMI) and associated

41、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, ETSI TR 102 655 i.2. National transposition dates Date of adoption of this EN: 12 September 2016 Date of latest announcement of this EN (doa): 31 Decembe

42、r 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 Modal verbs terminology In the present document “shall“, “shall not“, “should“, “should not“, “may“, “need not“, “wil

43、l“, “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 NOT allowed in ETSI deliverables except when used in direct citation. ETSI ETSI EN 301 559 V2.1.1 (2016-10) 8 Intr

44、oduction The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive (RE-D) i.1. The modular structure is shown in ETSI EG 201 399 i.4

45、. LP-AMI/LP-AMI-P equipment in the AMICS is a unique technology using the frequency band 2 483,5 MHz to 2 500 MHz, that will provide for example high speed communications capability between individuals with AIMDs and medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosi

46、ng and delivering therapy to individuals with various illnesses. Equipment in the AMICS consists of LP-AMI and/or LP-AMI-P that provide human therapeutic and diagnostic data storage and analysis capability. The present document includes methods of measurement for Low Power Active Medical Implants (L

47、P-AMI), and Peripherals (LP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing the characteristics being measured are not expected to

48、 be affected. The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are European wide harmonised for the SRD category “active medical implant devices“ according to 2013/752/EU i.13. If equipment, which is available on the market, is required to be checked it should be tested in accor

49、dance with the methods of measurement specified in the present document. The present document is structured as follows: Clauses 1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter are primarily designed to minimize the possibility of disturbance between LP-AMI/LP-AMI-P equipment and other users of the 2 483,5 MHz to 2 500 MHz frequency