1、 ETSI EN 302 510 V2.1.1 (2017-01) Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53
2、/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 302 510 V2.1.1 (2017-01) 2 Reference REN/ERM-TG30-308 Keywords harmonised standard, 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
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7、ng 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 Standards Institute 2017.
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9、ed and owned by the GSM Association. ETSI ETSI EN 302 510 V2.1.1 (2017-01) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 7g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 8g33 Definitions, symbols and abbreviatio
10、ns . 9g33.1 Definitions 9g33.2 Symbols 11g33.3 Abbreviations . 11g34 Technical requirements specifications . 11g34.1 Environmental profile . 11g34.2 Conformance requirements 11g34.2.1 Transmitter requirements 11g34.2.1.1 Effective Radiated Power 11g34.2.1.1.1 Definition. 11g34.2.1.1.2 Limits 11g34.2
11、.1.1.3 Conformance . 12g34.2.1.2 Out of band emissions . 12g34.2.1.2.1 Definition. 12g34.2.1.2.2 Limits 12g34.2.1.2.3 Conformance . 12g34.2.1.3 Unwanted emissions in the spurious domain of transmitters 12g34.2.1.3.1 Definition. 12g34.2.1.3.2 Limits 12g34.2.1.3.3 Conformance . 13g34.2.1.4 Duty Cycle
12、13g34.2.1.4.1 Definition. 13g34.2.1.4.2 Limits 13g34.2.1.4.3 Conformance . 13g34.2.2 Receiver requirements 13g34.2.2.1 Receiver Blocking or Desensitization . 13g34.2.2.1.0 Receiver Classification 13g34.2.2.1.1 Definition. 14g34.2.2.1.2 Limits 14g34.2.2.1.3 Conformance . 14g34.2.2.2 Receiver Spurious
13、 radiation 14g34.2.2.2.1 Definition. 14g34.2.2.2.2 Limits 14g34.2.2.2.3 Conformance . 14g34.3 Mechanical and electrical design 15g34.3.1 General 15g34.3.2 Controls 15g34.3.3 Transmitter shut-off facility 15g35 Testing for compliance with technical requirements 15g35.1 Environmental conditions for te
14、sting . 15g35.1.0 General provisions 15g35.1.1 Presentation of equipment for testing purposes 15g35.1.1.0 General provisions 15g35.1.1.1 Choice of model for testing . 15g35.1.1.2 Testing of equipment with alternate power levels . 16g3ETSI ETSI EN 302 510 V2.1.1 (2017-01) 4 5.1.1.3 Testing of equipme
15、nt that does not have an external RF connector (integral antenna equipment) . 16g35.1.1.3.0 General Provision 16g35.1.1.3.1 Equipment with an internal permanent or temporary antenna connector 16g35.1.1.3.2 Equipment with a temporary antenna connector . 16g35.1.1.3.3 Equipment intended to be implante
16、d in a human body 16g35.1.2 Declaration by the applicant . 16g35.1.3 Auxiliary test equipment . 16g35.1.4 Test Conditions . 17g35.1.4.1 Normal and extreme test conditions 17g35.1.4.2 Test power source . 17g35.1.4.2.0 General provisions . 17g35.1.4.2.1 External test power source . 17g35.1.4.2.2 Inter
17、nal test power source 17g35.1.4.3 Normal test conditions 18g35.1.4.3.1 Normal temperature and humidity . 18g35.1.4.3.2 Normal test power source 18g35.1.4.4 Extreme test conditions . 18g35.1.4.4.1 Extreme temperatures 18g35.1.4.4.2 Extreme test source voltages . 20g35.1.4.5 Normal test signals and te
18、st modulation 20g35.1.4.5.0 General provisions . 20g35.1.4.5.1 Normal modulation test signals for data 20g35.1.4.6 Antennas . 21g35.1.4.6.0 General provisions . 21g35.1.4.6.1 Artificial antenna . 21g35.1.4.6.2 Artificial antenna for transmitters with 50 impedance connector 21g35.1.4.7 Test fixture f
19、or ULP-AMI-M-P . 21g35.1.4.8 Test fixture for ULP-AMI-M 22g35.1.4.9 Test sites and general arrangements for radiated measurements . 22g35.1.4.10 Modes of operation of the transmitter . 22g35.1.4.11 Measuring receiver 22g35.2 Interpretation of the measurement results 23g35.3 Methods of measurement .
20、23g35.3.1 Maximum Effective Radiated Power 23g35.3.2 Out of band emissions. 24g35.3.3 Unwanted Emissions in the spurious domain . 25g35.3.4 Duty Cycle 26g35.3.5 Receiver Blocking or desensitization 26g35.3.6 Receiver Spurious radiation 26g3Annex A (normative): Relationship between the present docume
21、nt and the essential requirements of Directive 2014/53/EU . 28g3Annex B (normative): Radiated Measurement . 29g3B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29g3B.1.1 Outdoor test site . 29g3B.1.1.0 General remarks 29g3B.1.1.1 Standard position 29g3
22、B.1.1.2 Equipment in close proximity to the human body but external to it . 30g3B.1.1.3 Human torso simulator for ULP-AMI-M 30g3B.1.2 Test antenna 31g3B.1.3 Substitution antenna . 31g3B.1.4 Optional additional indoor site . 32g3B.2 Guidance on the use of radiation test sites . 33g3B.2.0 General rema
23、rks . 33g3B.2.1 Measuring distance . 33g3B.2.2 Test antenna 33g3B.2.3 Substitution antenna . 33g3B.2.4 Artificial antenna 33g3B.2.5 Auxiliary cables 33g3ETSI ETSI EN 302 510 V2.1.1 (2017-01) 5 B.3 Further optional alternative indoor test site using an anechoic chamber . 34g3B.3.0 General remarks . 3
24、4g3B.3.1 Example of the construction of a shielded anechoic chamber 34g3B.3.2 Influence of parasitic reflections in anechoic chambers . 34g3B.3.3 Calibration of the shielded RF anechoic chamber 35g3Annex C (normative): Technical performance of the spectrum analyser . 37g3Annex D (informative): Bibli
25、ography . 38g3History 39g3ETSI ETSI EN 302 510 V2.1.1 (2017-01) 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-me
26、mbers, 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 (https:/ipr.etsi.org/). Pursua
27、nt 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 to the present docum
28、ent. Foreword This Harmonised 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.7 to provide one voluntary mean
29、s 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 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 Europ
30、ean Union under that Directive, 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 regulation
31、s. National transposition dates Date of adoption of this EN: 27 December 2016 Date of latest announcement of this EN (doa): 31 March 2017 Date of latest publication of new National Standard or endorsement of this EN (dop/e): 30 September 2017 Date of withdrawal of any conflicting National Standard (
32、dow): 30 September 2018 Modal 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).
33、 “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct citation. ETSI ETSI EN 302 510 V2.1.1 (2017-01) 7 Introduction Membrane Implants and associated peripheral equipment are a new technology in the medical field that provides, on a continuing non-invasive basis afte
34、r the implant is inserted, patient related real time intravenous blood pressure information to the attending physician. This information is used for purposes of diagnosing and treating certain heart related disorders thereby reducing significantly the hospital readmission rate. The present document
35、is a specific product standard applicable to Ultra Low Power Active Medical Membrane Implants and Peripherals operating in the frequency range 30 MHz to 37,5 MHz. The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category “active medical implant device
36、s“ according to 2013/752/EU i.10. The present document is structured in the following way: Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides the technical requirements, sp
37、ecifications, 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 interpretation of the measurement results with the maximum measurement uncertainty values. Clause 5.3 specifies the required measur
38、ement methods. In particular clause 5.3.8 describes the monitoring system performance specifications that have been chosen to minimize harmful interference to other equipment or services and minimize the potential for disturbance to this equipment from ambient sources or other medical device users i
39、n the band. Annex A (normative) provides the relationship between the present document and the essential requirements of Directive 2014/53/EU i.1. Annex B (normative) provides specifications concerning radiated measurements. Annex C (normative) provides technical performance of the spectrum analyser
40、. Annex D (informative) bibliography; provides additional information. ETSI ETSI EN 302 510 V2.1.1 (2017-01) 8 1 Scope The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant Peripherals as described in Directive 90/385/EEC i.4, covering all active medic
41、al implants, that operate in a Medical Implant Communications System in the frequency band 30 MHz to 37,5 MHz. Table 1: Ultra Low Power Active Medical Membrane Implants and Peripherals operating in the frequency band 30 MHz to 37,5 MHz Ultra Low Power Active Medical Membrane Implants and Peripherals
42、 service frequency bands Transmitters - Ultra Low Power Active Medical Membrane Implants and peripherals 30 MHz to 37,5 MHz Receivers - Ultra Low Power Active Medical Membrane Implants and peripherals 30 MHz to 37,5 MHz The present document contains the technical requirements for characteristics of
43、ULP-AMI-M and ULP-AMI-M-P radio equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 i.6. The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category “active medical implant devices“ according to 2013/752/EU i.10 with
44、the following usage restrictions: “This set of usage conditions is only available to ultra-low power medical membrane implants for blood pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC.“ The present document contains requirements to demonstra
45、te that Ultra Low Power Active Medical Membrane Implants and peripherals used in a medical membrane implant communications system “ 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 Direc
46、tive 2014/53/EU i.1). It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. 2 References 2.1 Normative references References are either specific (identified by date of publication and/or edition
47、 number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. Referenced documents which are not found to be publicly available in the expected locati
48、on might be found at https:/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. The following referenced documents are necessary for the application of the present document. 1 CISPR 16-2
49、-3 (2010): “Specification for radio disturbance and immunity measuring apparatus and methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements“. 2.2 Informative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. ETSI ETSI EN 302 510 V2.1.1 (
