1、 ETSI EN 301 839 V2.1.1 (2016-04) Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU HARMONISED EUROPEAN STAND
2、ARD ETSI ETSI EN 301 839 V2.1.1 (2016-04) 2 Reference REN/ERM-TG30-306 Keywords radio, regulation 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 enregistre la Sous-P
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9、301 839 V2.1.1 (2016-04) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 7g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 9g33 Definitions, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 11g33.3 Abb
10、reviations . 12g34 Technical requirements specifications . 12g34.1 Environmental profile . 12g34.2 Conformance requirements 12g34.2.1 Transmitter requirements 12g34.2.1.1 Frequency error . 12g34.2.1.1.1 Definition. 12g34.2.1.1.2 Limits 12g34.2.1.1.3 Conformance . 13g34.2.1.2 Emission bandwidth 13g34
11、.2.1.2.1 Definition. 13g34.2.1.2.2 Limits 13g34.2.1.2.3 Conformance . 13g34.2.1.3 Effective radiated power of the fundamental emission . 13g34.2.1.3.1 Definition. 13g34.2.1.3.2 Limits 13g34.2.1.3.3 Conformance . 13g34.2.1.4 Spurious emissions of transmitter . 14g34.2.1.4.1 Definition. 14g34.2.1.4.2
12、Limits 14g34.2.1.4.3 Conformance . 14g34.2.1.5 Frequency stability under low voltage conditions . 14g34.2.1.5.1 Definition. 14g34.2.1.5.2 Limits 14g34.2.1.5.3 Conformance . 14g34.2.2 Receiver requirements 14g34.2.2.1 Spurious radiation of receivers 14g34.2.2.1.1 Definition. 14g34.2.2.1.2 Limits 14g3
13、4.2.2.1.3 Conformance . 15g34.2.3 Transmitter and Receiver requirements 15g34.2.3.1 Spectrum Access . 15g34.2.3.1.0 General requirements . 15g34.2.3.1.1 LBT/AFA spectrum access 15g34.2.3.1.2 LP/LDC spectrum access. 15g34.2.3.2 Receiver blocking . 16g34.2.3.2.1 Definition. 16g34.2.3.2.2 Limits 16g34.
14、2.3.2.3 Conformance . 16g34.3 Mechanical and electrical design 16g34.3.1 General 16g34.3.2 Antennas . 16g34.3.3 Controls 17g3ETSI ETSI EN 301 839 V2.1.1 (2016-04) 4 4.3.4 Transmitter shut-off facility 17g35 Testing for compliance with technical requirements 17g35.1 Environmental conditions for testi
15、ng . 17g35.1.0 General provisions 17g35.1.1 Presentation of equipment for testing purposes 17g35.1.1.0 General provisions . 17g35.1.1.1 Choice of model for testing . 17g35.1.1.2 Testing of equipment with alternative power levels 17g35.1.1.3 Presentation of equipment that does not have an external RF
16、 connector (integral antenna equipment) 18g35.1.1.3.1 Equipment with an internal permanent or temporary antenna connector 18g35.1.1.3.2 Equipment with a temporary antenna connector . 18g35.1.1.3.3 Equipment intended to be implanted in a human body 18g35.1.2 Declarations by the Applicant . 18g35.1.3
17、Auxiliary test equipment . 18g35.1.4 Test Conditions . 18g35.1.4.1 Normal and extreme test conditions 18g35.1.4.2 Test power source . 18g35.1.4.2.0 General provisions . 18g35.1.4.2.1 External test power source . 19g35.1.4.2.2 Internal test power source 19g35.1.4.3 Normal test conditions 19g35.1.4.3.
18、1 Normal temperature and humidity . 19g35.1.4.3.2 Normal test power source 19g35.1.4.4 Extreme test conditions . 20g35.1.4.4.1 Extreme temperatures 20g35.1.4.4.2 Extreme test source voltages . 21g35.1.4.5 Normal test signals and test modulation 22g35.1.4.5.0 General provisions . 22g35.1.4.5.1 Normal
19、 modulation test signals for data 22g35.1.4.6 Antennas . 22g35.1.4.6.0 General provisions . 22g35.1.4.6.1 Artificial antenna . 22g35.1.4.6.2 Artificial antenna for transmitters with 50 impedance connector 22g35.1.4.7 Test fixture for ULP-AMI-P . 22g35.1.4.8 Test fixture for ULP-AMI . 23g35.1.4.9 Tes
20、t sites and general arrangements for radiated measurements . 23g35.1.4.10 Modes of operation of the transmitter . 23g35.1.4.11 Measuring receiver 23g35.2 Interpretation of the measurement results 24g35.3 Methods of measurement . 25g35.3.1 Frequency error . 25g35.3.1.0 General provisions 25g35.3.1.1
21、Method of measurement for systems with an unmodulated carrier frequency operating mode 25g35.3.1.2 Method of measurement for systems with a modulated carrier frequency 25g35.3.2 Emission bandwidth 26g35.3.3 Effective radiated power of the fundamental emission . 26g35.3.4 Spurious emissions of transm
22、itter . 27g35.3.5 Frequency stability under low voltage conditions 29g35.3.6 Spurious radiation of receivers . 29g35.3.7 Spectrum Access . 30g35.3.7.1 LBT/AFA spectrum access . 30g35.3.7.1.0 General provisions. 30g35.3.7.1.1 Purpose 30g35.3.7.1.2 General Remarks on the Measurement Configuration . 31
23、g35.3.7.1.3 LBT threshold power level 31g35.3.7.1.4 Monitoring system bandwidth . 32g35.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 34g35.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh35g35.3.7.1.7 Disco
24、ntinuation of MICS session if a silent period greater than or equal to 5 seconds occurs 36g3ETSI ETSI EN 301 839 V2.1.1 (2016-04) 5 5.3.7.1.8 Use of pre-scanned alternative channel . 36g35.3.8 Receiver blocking . 39g35.3.8.0 General remarks 39g35.3.8.1 Measurement method using out-of-operating-regio
25、n disturbance . 39g35.3.8.2 Measurement method using frequency administration commands . 40g35.3.8.3 Results based on the above test method 40g3Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 41g3Annex B (normative): Radiated me
26、asurements 42g3B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 42g3B.1.1 Outdoor test site . 42g3B.1.1.0 Introduction. 42g3B.1.1.1 Standard position 42g3B.1.1.2 Equipment in close proximity to the human body but external to it . 43g3B.1.1.3 Human torso
27、 simulator for ULP-AMI 43g3B.1.2 Test antenna 44g3B.1.3 Substitution antenna . 44g3B.1.4 Optional additional indoor site . 45g3B.2 Guidance on the use of radiation test sites . 46g3B.2.0 Introduction 46g3B.2.1 Measuring distance . 46g3B.2.2 Test antenna 46g3B.2.3 Substitution antenna . 46g3B.2.4 Art
28、ificial antenna 46g3B.2.5 Auxiliary cables 46g3B.3 Further optional alternative indoor test site using an anechoic chamber . 47g3B.3.0 Introduction 47g3B.3.1 Example of the construction of a shielded anechoic chamber 47g3B.3.2 Influence of parasitic reflections in anechoic chambers . 47g3B.3.3 Calib
29、ration of the shielded RF anechoic chamber 48g3Annex C (normative): Technical performance of the spectrum analyser . 50g3Annex D (informative): Bibliography . 51g3History 52g3ETSI ETSI EN 301 839 V2.1.1 (2016-04) 6 Intellectual Property Rights IPRs essential or potentially essential to the present d
30、ocument 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, or potentially Essential, IPRs notified to ETSI in respect
31、 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 by ETSI. No guarantee can be given as to the existence of oth
32、er 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 Committee Electromagnetic compatibility and Radio spectrum Mat
33、ters (ERM). The present document has been prepared under the Commissions standardisation request C(2015) 5376 final i.9 to provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making avai
34、lable 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 Directive, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scop
35、e of the present document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. National transposition dates Date of adoption of this EN: 25 April 2016 Date of latest announcement of this EN (doa): 31 July 2016 Date of latest p
36、ublication of new National Standard or endorsement of this EN (dop/e): 31 January 2017 Date of withdrawal of any conflicting National Standard (dow): 31 January 2018 Modal verbs terminology In the present document “shall“, “shall not“, “should“, “should not“, “may“, “need not“, “will“, “will not“, “
37、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 301 839 V2.1.1 (2016-04) 7 Introduction ULP-AMI/
38、ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical field, that provides high speed communications capability between individuals with AIMDs and medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering ther
39、apy to individuals with various illnesses. Equipment in the MICS service consists of active medical implants that communicate to other active medical implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters. The present document includes methods of measurement for Ultra Low Powe
40、r Active Medical Implants (ULP-AMI) and Peripherals (ULP-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
41、 measured are not expected to be affected. If equipment, which is available on the market, is required to be checked it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covere
42、d 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 equipment and interp
43、retation of the measurement results with the maximum measurement uncertainty values. Clause 5.3.7 specifies the required measurement methods. In particular clause 5.3.7.1 describes the monitoring system performance specifications that have been chosen to minimize harmful interference to other equipm
44、ent 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 i.2. Annex B (normative) prov
45、ides specifications concerning radiated measurements. Annex C (normative) provides technical performance of the spectrum analyser. Annex D (informative) bibliography; provides additional information. ETSI ETSI EN 301 839 V2.1.1 (2016-04) 8 1 Scope The present document applies to the following radio
46、equipment types: Ultra Low Power Active Medical Implants (ULP-AMI). Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) an
47、d Peripherals (ULP-AMI-P) operating frequency bands Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating frequency bands Transmit Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical
48、 Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 i.1. It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency b
49、and 402 MHz to 405 MHz: for telecommand and telemetry to/from an AIMD in a patients body to an ULP-AMI-P; or for telecommand and telemetry to/from an AIMD to another AIMD within the human body. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS) “ shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference“ (article 3.2 of the Direct
