1、 ETSI EN 301 489-31 V2.1.1 (2016-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Sta
2、ndard covering the essential requirements of article 3.1(b) of the Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)2 Reference REN/ERM-EMC-337 Keywords EMC, harmonised standard, LF, radio, regulation, short range ETSI 650 Route des Lucioles F-06921 Sophia An
3、tipolis 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-Prfecture de Grasse (06) N 7803/88 Important notice The present document can be downloaded from: http:/www.etsi.org/standards-search The present
4、 document may be made available in electronic versions and/or in print. The content 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
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6、nt status of this and other ETSI documents is available at https:/portal.etsi.org/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 par
7、t may be reproduced or utilized in any form or by any means, electronic or mechanical, 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 forego
8、ing restriction extend to reproduction in all media. European Telecommunications 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 be
9、nefit 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 301 489-31 V2.1.1 (2016-11)3 Contents Intellectual Property Rights 5g3Foreword . 5g3Modal verbs terminology 5g31 Scope 6g32 References 6g32.1 N
10、ormative references . 6g32.2 Informative references 7g33 Definitions, symbols and abbreviations . 7g33.1 Definitions 7g33.2 Symbols 7g33.3 Abbreviations . 8g34 Test conditions . 8g34.1 General . 8g34.2 Arrangements for test signals . 8g34.2.0 General 8g34.2.1 Arrangements for test signals at the inp
11、ut of transmitters . 8g34.2.2 Arrangements for test signals at the RF output of transmitters . 9g34.2.2.1 General 9g34.2.2.2 ULP-AMI transmitters 9g34.2.2.3 ULP-AMI-P transmitters. 9g34.2.3 Arrangements for test signals at the RF input of receivers . 9g34.2.4 Arrangements for test signals at the out
12、put of receivers . 9g34.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) . 9g34.3 RF exclusion band of radio equipment . 10g34.3.0 General 10g34.3.1 Exclusion bands for receiver . 10g34.3.2 Exclusion band for transmitters 10g
13、34.4 Narrow band responses of receivers or receivers which are part of transceivers . 10g34.5 Normal test modulation 10g35 Performance assessment . 10g35.1 General . 10g35.2 Equipment which can provide a continuous communication link 11g35.3 Equipment which does not provide a continuous communicatio
14、n link 11g35.4 Ancillary equipment . 11g35.5 Equipment classification 11g36 Performance criteria . 11g36.1 Classification of ULP-AMI and ULP-AMI-P 11g36.2 General performance criteria 12g36.3 Performance criteria and table 12g36.4 Performance criteria for continuous phenomena applied to transmitters
15、 . 13g36.5 Performance criteria for transient phenomena applied to transmitters . 13g36.6 Performance criteria for continuous phenomena applied to receivers 14g36.7 Performance criteria for transient phenomena applied to receivers 14g37 Applicability overview . 14g37.1 EMC emission 14g37.1.1 General
16、 14g37.1.2 Special conditions . 14g37.2 Immunity 14g37.2.1 General 14g37.2.2 Special conditions . 15g3ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)4 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 18g3Annex B (informative): Test fixt
17、ure for ULP-AMI (Simulated man) . 20g3Annex C (informative): Simultaneous testing of ULP-AMI/ULP-AMI-P and parts covered by AIMD 22g3History 23g3ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)5 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declar
18、ed 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 of ETSI standards“, which i
19、s 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 other IPRs not referenced in ET
20、SI 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 Matters (ERM). The present docu
21、ment has been prepared under the Commissions standardisation request C(2015) 5376 final i.4 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 available on the market of radio
22、 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 document given in table A.1 confers, within the limits of the scope of the present document, a
23、 presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations. The present document is part 31 of a multi-part deliverable. Full details of the entire series can be found in ETSI EN 301 489-1 1. National transposition dates Date of adoptio
24、n of this EN: 21 November 2016 Date of latest announcement of this EN (doa): 28 February 2017 Date of latest publication of new National Standard or endorsement of this EN (dop/e): 31 August 2017 Date of withdrawal of any conflicting National Standard (dow): 31 August 2018 Modal verbs terminology In
25、 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). “must“ and “must not“ are NOT allowed in ETSI del
26、iverables except when used in direct citation. ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)6 1 Scope The present document together with ETSI EN 301 489-1 1 covers the assessment of all radio transceivers associated with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receiver
27、s operating in the range from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of ElectroMagnetic Compatibility (EMC). Non-radio pa
28、rts of the above equipment may be covered by other directives and/or standards when applicable. Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these devices are not included in the present document. Such technical specifications are
29、 found in the relevant product standards for the effective use of the radio spectrum. The present document specifies the applicable test conditions, performance assessment, and performance criteria for assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps. In case of differences (fo
30、r instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489-1 1, the provisions of the present document take precedence. The environmental classification and the emission and immunity requirements used in the present document are as stated i
31、n the ETSI EN 301 489-1 1, except for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 1, contains requirements to demonstrate an adequate level of electromagnetic compatibility as set out in Directive 2014/53/EU i.1. 2 References 2.1 Nor
32、mative 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)
33、 applies. Referenced documents which are not found to be publicly available in the expected location 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 foll
34、owing referenced documents are necessary for the application of the present document. 1 ETSI EN 301 489-1 (V2.1.1) (11-2016): “ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements
35、 of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU“. 2 ETSI EN 302 195 (V2.0.1) (03-2016): “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
36、covering the essential requirements of article 3.2 of the Directive 2014/53/EU“. 3 CENELEC EN 60601-1-2 (2007): “Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests“. 4
37、CENELEC EN 61000-4-5 (2014): “Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test“. ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)7 2.2 Informative references References are either specific (identified by date of publication and/or edition number or ver
38、sion 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. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot
39、guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. i.1 Directive 2014/53/EU of the European Parliament and of the council of 16 April 2014 on the harmo
40、nisation 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 Camelia Gabriel: “Compilation of the dielectric properties of body tissues at RF and Microwave Frequencies“, Physics Department, Kings College, London WC
41、2R 2LS, UK. i.3 Void. i.4 Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request to the European Committee for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/
42、EU of the European Parliament and of the Council. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in ETSI EN 301 489-1 1, ETSI EN 302 195 2 and Directive 2014/53/EU i.1 apply, unless otherwise ascribed herein. emissio
43、n bandwidth: bandwidth between two points that are 20 dB down on either side of the frequency with the maximum level in the modulation envelope environmental profile: range of environmental conditions under which equipment within the scope of the present document is required to comply with the provi
44、sions of the present document H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the field can be measured life supporting equipment: equipment or system that includes at least one function that is intended to actively keep alive or resuscita
45、te patients and the failure of which is likely to lead to serious injury or death of a patient non-radio part: those portions of a device not used for communication via electromagnetic waves radio part: that portion of a device used for communication via electromagnetic waves Ultra Low Power Active
46、Medical Implant (ULP-AMI): radio part of an active medical implant Ultra Low Power Active Medical Implant Peripheral device (ULP-AMI-P): radio part of equipment outside the human body, including body worn devices and monitors, used to program and/or control or receive data from an ULP-AMI 3.2 Symbol
47、s For the purposes of the present document, the symbols given in ETSI EN 301 489-1 1, ETSI EN 302 195 2 and Directive 2014/53/EU i.1 apply. ETSI ETSI EN 301 489-31 V2.1.1 (2016-11)8 3.3 Abbreviations For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 1, ETSI EN 30
48、2 195 2 and Directive 2014/53/EU i.1 apply, unless otherwise ascribed herein: AC Alternating Current AIMD Active Implantable Medical Device AMI Active Medical Implant DC Direct Current EMC ElectroMagnetic Compatibility EUT Equipment Under Test ISM Industria, Scientific and Medical RF Radio Frequency
49、 ULP-AMI Ultra Low Power-Active Medical Implant ULP-AMI-P Ultra Low Power-Active Medical Implant Peripheral device 4 Test conditions 4.1 General For the purposes of the present document, the test conditions of ETSI EN 301 489-1 1, clause 4 shall apply as appropriate. Further product related test conditions for equipment covered by the scope of the present document are specified herein. For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present document, clauses 4.1 to 4.
