1、 ETSI EN 302 195 V2.1.1 (2016-06) Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU HARMONISED E
2、UROPEAN STANDARD ETSI ETSI EN 302 195 V2.1.1 (2016-06) 2 Reference REN/ERM-TG30-310 Keywords health, inductive, magnetic, mobile, radio, regulation, short range, 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 34
3、8 623 562 00017 - NAF 742 C Association but non lucratif enregistre la Sous-Prfecture de Grasse (06) N 7803/88 Important notice The present document can be downloaded from: http:/www.etsi.org/standards-search The present document may be made available in electronic versions and/or in print. The cont
4、ent of any electronic and/or print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the print of the Portable Docu
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6、g/TB/ETSIDeliverableStatus.aspx If you find errors in the present document, please send your comment to one of the following services: https:/portal.etsi.org/People/CommiteeSupportStaff.aspx Copyright Notification No part may be reproduced or utilized in any form or by any means, electronic or mecha
7、nical, including 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
8、 Standards 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 lo
9、go are Trade Marks registered and owned by the GSM Association. ETSI ETSI EN 302 195 V2.1.1 (2016-06) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 6g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 9g33 Definitio
10、ns, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 10g33.3 Abbreviations . 10g34 Technical requirements specifications . 11g34.1 Environmental profile . 11g34.2 Transmitter requirements . 11g34.2.1 Radiated field strength 11g34.2.1.0 General 11g34.2.1.1 Radiated H-field 11g34.2.1.1.0
11、General 11g34.2.1.1.1 Definition. 11g34.2.1.1.2 Limits 12g34.2.1.1.3 Conformance . 12g34.2.2 Permitted range of modulation bandwidth 12g34.2.2.0 General 12g34.2.2.1 Definition 12g34.2.2.2 Limits 12g34.2.2.3 Conformance . 13g34.2.3 Spurious emissions . 13g34.2.3.0 General 13g34.2.3.1 Definition 13g34
12、.2.3.2 Limits 13g34.2.3.3 Conformance . 13g34.2.4 Duty cycle . 13g34.2.4.0 General 13g34.2.4.1 Definitions . 13g34.2.4.2 Limits 13g34.2.4.3 Conformance . 13g34.3 Receiver requirements 14g34.3.1 Receiver Classification . 14g34.3.2 Blocking 14g34.3.2.0 General 14g34.3.2.1 Definition 14g34.3.2.2 Limits
13、 14g34.3.2.3 Conformance . 15g34.3.3 Receiver spurious radiations . 15g34.3.3.0 General 15g34.3.3.1 Definition 15g34.3.3.2 Limits 15g34.3.3.3 Conformance . 15g35 Testing for compliance with technical requirements 15g35.1 Environmental conditions for testing . 15g35.1.0 General remarks 15g35.1.1 Pres
14、entation of equipment for testing purposes 16g3ETSI ETSI EN 302 195 V2.1.1 (2016-06) 4 5.1.2 Choice of model for testing 16g35.1.3 Presentation of equipment that does not have an external 50 uni2126 RF connector (integral antenna equipment) 16g35.1.3.0 General remarks 16g35.1.3.1 Equipment with an i
15、nternal permanent or temporary antenna connector 16g35.1.3.2 Equipment with a temporary antenna connector . 16g35.1.4 Controls 17g35.1.5 Transmitter shut-off facility 17g35.1.6 Receiver power save capability 17g35.1.7 Equipment intended to be implanted in a human body . 17g35.1.8 Declarations by the
16、 Applicant . 17g35.1.9 Auxiliary test equipment . 17g35.1.10 Test conditions 17g35.1.10.1 Normal and extreme test-conditions 17g35.1.10.2 Test power source . 17g35.1.10.2.0 General remarks. 17g35.1.10.2.1 External test power source . 18g35.1.10.2.2 Internal test power source 18g35.1.10.3 Normal test
17、 Condition . 18g35.1.10.3.1 Normal temperature and humidity . 18g35.1.10.3.2 Normal test power source 18g35.1.10.4 Extreme test conditions . 19g35.1.10.4.1 Extreme temperatures 19g35.1.10.4.2 Extreme test source voltages . 20g35.1.10.5 Normal test signals and test modulation 21g35.1.10.5.0 General r
18、emarks. 21g35.1.10.5.1 Normal modulation test signals for data 21g35.1.10.6 Antenna . 21g35.1.10.6.0 General remarks. 21g35.1.10.6.1 Artificial Antenna 21g35.1.10.7 Test fixture 22g35.1.10.7.0 General remarks. 22g35.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a huma
19、n body 22g35.1.10.8 Test sites and general arrangements for radiated measurements . 22g35.1.10.9 Modes of operation of the transmitter . 22g35.1.10.10 Measuring receiver 23g35.2 Interpretation of the measurement results 23g35.3 Method of Measurements . 23g35.3.1 Radiated field strength 23g35.3.1.0 G
20、eneral remarks 23g35.3.1.1 Radiated Field Strength (H-field) 24g35.3.2 Permitted frequency range of the modulation bandwidth . 24g35.3.3 Spurious emissions . 25g35.3.4 Receiver requirement 25g35.3.4.1 Blocking 25g35.3.4.2 Receiver spurious radiation . 26g3Annex A (normative): Relationship between th
21、e present document and the essential requirements of Directive 2014/53/EU . 27g3Annex B (normative): Radiated measurements 28g3B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 28g3B.1.1 Outdoor test site . 28g3B.1.1.0 General remarks 28g3B.1.1.1 Standar
22、d position 28g3B.1.1.2 Equipment in close proximity to the human body but external to it . 29g3B.1.1.3 Active medical implant equipment . 29g3B.1.2 Test antenna 31g3B.1.2.1 Below 30 MHz 31g3B.1.3 Optional additional indoor site . 31g3B.2 Guidance on the use of radiation test sites . 31g3ETSI ETSI EN
23、 302 195 V2.1.1 (2016-06) 5 B.2.0 General remarks . 31g3B.2.1 Measuring distance . 32g3B.2.2 Auxiliary cables 32g3Annex C (normative): H-field measurements at other distances than 10 m . 33g3Annex D (informative): Bibliography . 35g3History 36g3ETSI ETSI EN 302 195 V2.1.1 (2016-06) 6 Intellectual Pr
24、operty 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-members, and can be found in ETSI SR 000 314: “Intellectual Property Rights (IPRs);
25、 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/). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been car
26、ried 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 document. Foreword This Harmonised European Standard (EN) has been produced by ETSI Te
27、chnical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared under the Commissions standardisation request C(2015) 5376 final i.6 to provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harm
28、onisation 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.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 pres
29、ent 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 regulations. National transposition dates Date of adoption of this EN: 14 June 2016 Date of
30、 latest announcement of this EN (doa): 30 September 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e): 31 March 2017 Date of withdrawal of any conflicting National Standard (dow): 31 March 2018 Modal verbs terminology In the present document “shall“, “shall n
31、ot“, “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). “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct ci
32、tation. Introduction The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate in the frequency range of 9 kHz to 315 kHz for the purpose of pr
33、oviding a digital communication link. The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral antenna may use a temporary or permanent internal conn
34、ector for the purpose of testing, provided the characteristics being measured are representative of the final product placed on the market. ETSI ETSI EN 302 195 V2.1.1 (2016-06) 7 If equipment already placed on the market is required to be inspected it should be tested in accordance with the methods
35、 of measurement specified in the present document. 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 specifications, limits and conformance rela
36、tive to transmitter and receiver function. 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 measurement methods. Annex A (normative) provides the re
37、lationship between the present document and the essential requirements of Directive 2014/53/EU i.2. Annex B (normative) provides specifications concerning radiated measurements. Annex C (normative) provides procedures for H-field measurements at other distances than 10 m. Annex D (informative) bibli
38、ography; provides additional information. ETSI ETSI EN 302 195 V2.1.1 (2016-06) 8 1 Scope The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any associated Peripherals (ULP-AMI-P) transmitters and receivers operating in the frequency range of
39、 9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the present document. The present document applies to
40、 ULP-AMI/ULP/AMI-P transmitters and receivers: transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m; receivers operating in the range from 9 kHz to 315 kHz. The present document applies to ULP-AMI devices: either with a Radio Frequency (RF) output co
41、nnection and dedicated antenna, or with an integral antenna; for telecommand, telemetry etc. applications; for all types of digital modulation. The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and po
42、rtable stations (implanted devices providing medical benefit to the implanted patient). The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 i.1. The present doc
43、ument contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz “shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid ha
44、rmful interference“ (article 3.2 of the Directive 2014/53/EU) i.2. 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 (ide
45、ntified 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. Referenced documents which are not found to
46、 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. The following referenced documents are necessary for the applic
47、ation of the present document. Not applicable. ETSI ETSI EN 302 195 V2.1.1 (2016-06) 9 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 n
48、on-specific references, the latest version of the referenced document (including any amendments) applies. 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 not necessary for
49、 the application of the present document but they assist the user with regard to a particular subject area. i.1 CEPT/ERC Recommendation 70-03: “Relating to the use of Short Range Devices (SRD)“. i.2 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 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.3 ETSI TR 100 028 (all parts) (V1.4.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertaint
