ETSI EN 301 489-27-2016 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services Part 27 Specific conditions for Ultra Low Power Active Medical Implants (ULP-A_1.pdf

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1、 ETSI EN 301 489-27 V2.1.1 (2016-12) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements o

2、f article 3.1(b) of Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)2 Reference REN/ERM-EMC-352 Keywords EMC, harmonised standard, radio, regulation, short range ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE Tel.: +33 4 92 94 42 00 Fax:

3、 +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 document may be made available in electronic versi

4、ons 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 and/or in print, the only prevailing document is t

5、he print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is avail

6、able 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 part may be reproduced or utilized in any form or by a

7、ny 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 foregoing restriction extend to reproduction in all media

8、. 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 benefit of its Members and of the 3GPP Organizational

9、 Partners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)3 Contents Intellectual Property Rights 5g3Foreword . 5g3Modal verbs terminology 5g31 Scope 6g32 References 6g32.1 Normative references . 6g32.2 Informative references

10、 7g33 Definitions and abbreviations . 7g33.0 Applicability . 7g33.1 Definitions 7g33.2 Abbreviations . 8g34 Test conditions . 8g34.1 General . 8g34.2 Arrangements for test signals . 9g34.2.0 General 9g34.2.1 Arrangements for test signals at the input of transmitters . 9g34.2.2 Arrangements for test

11、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 output of receivers . 9g34.2.5 Arrangements for testing

12、 transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) . 10g34.3 RF exclusion band of radio equipment . 10g34.3.0 General 10g34.3.1 Exclusion bands for receivers . 10g34.3.2 Exclusion band for transmitters 11g34.4 Narrow band responses of receivers or receive

13、rs which are part of transceivers . 11g34.5 Normal test modulation 11g35 Performance assessment . 11g35.1 General . 11g35.2 Equipment which can provide a continuous communication link 11g35.3 Equipment which does not provide a continuous communication link 12g35.4 Ancillary equipment . 12g35.5 Equip

14、ment classification 12g36 Performance criteria . 12g36.1 classification of ULP-AMI and ULP-AMI-P devices 12g36.2 General performance criteria 12g36.3 Performance criteria and table 13g36.4 Performance criteria for continuous phenomena applied to transmitters . 14g36.5 Performance criteria for transi

15、ent phenomena applied to transmitters . 14g36.6 Performance criteria for continuous phenomena applied to receivers 14g36.7 Performance criteria for transient phenomena applied to receivers 15g37 Applicability overview . 15g37.1 EMC emission 15g37.1.1 General 15g37.1.2 Special conditions . 15g37.2 Im

16、munity 15g37.2.1 General 15g37.2.2 Special conditions . 15g3ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)4 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 19g3Annex B (normative): Definitions of types of ULP-AMI and ULP-AMI-P devices

17、 in the scope of the present document 21g3B.1 ULP-AMI and ULP-AMI-P devices intended for operation in the frequency range 402 MHz to 405 MHz . 21g3Annex C (normative): Test fixture for ULP-AMI (Simulated man) . 22g3History 24g3ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)5 Intellectual Property Rights IP

18、Rs 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, or p

19、otentially 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 by ETSI

20、. 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 Committe

21、e Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document 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

22、 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 document giv

23、en 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 is part 27 of a multi-part deliverable. Full details of the entire series

24、 can be found in ETSI EN 301 489-1 1. National transposition dates Date of adoption of this EN: 12 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

25、any conflicting National Standard (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

26、 for the expression of provisions). “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct citation. ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)6 1 Scope The present document together with ETSI EN 301 489-1 1, covers the assessment of all radio transceivers associated wit

27、h Ultra Low Power Active Medical Implants (ULP-AMIs) and associated Peripheral ULP-AMI-Ps) in respect of ElectroMagnetic Compatibility (EMC). The present document covers the EMC requirements for the radio functions of ULP-AMI and ULP-AMI-P devices. Technical specifications related to the antenna por

28、t and emissions from the enclosure port of the ULP-AMI and ULP-AMI-P devices radio system are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document specifies the applicable tes

29、t conditions, performance assessment, and performance criteria for ULP-AMIs and associated Peripheral devices (ULP-AMI-Ps). Definitions of types of ULP-AMIs and ULP-AMI-Ps covered by present document are given in annex B. In case of differences (for instance concerning special conditions, definition

30、s, 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 in ETSI EN 301 489-1 1, except for any special condit

31、ions 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 Normative references References are either specific (identi

32、fied 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 be

33、 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 following referenced documents are necessary for the applica

34、tion 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 of article 3.1(b) of Directive 2014/53/EU and the essen

35、tial requirements of article 6 of Directive 2014/30/EU“. NOTE: Available at http:/www.etsi.org/deliver/etsi_en/301400_301499/30148901/02.01.01_30/en_30148901v020101v.pdf. 2 ETSI EN 301 839 (V2.1.1) (04-2016): “Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) o

36、perating 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“. 3 IEC EN 60601-1-2 (2007): “Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compati

37、bility - Requirements and tests“. 4 IEC EN 61000-4-5 (2006): “Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test“. ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)7 2.2 Informative references References are either specific (identified by date of publicat

38、ion 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. NOTE: While any hyperlinks included in this clause were valid at the t

39、ime of publication, ETSI cannot 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 counc

40、il 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.2 CEPT/ERC/REC 70-03: “Relating to the use of Short Range Devices (SRD)“. i.3 Camelia Gabriel: “Compilation of the dielectr

41、ic properties of body tissues at RF and Microwave Frequencies“, Physics Department, Kings College, London WC2R 2LS, UK. February 1996. NOTE: Available at http:/www.dtic.mil/dtic/tr/fulltext/u2/a305826.pdf. i.4 Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation reque

42、st to the European Committee for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/EU of the European Parliament and of the Council. i.5 Italian National Research Council, Institute for Applied Physi

43、cs. NOTE: Available at http:/r.it/. 3 Definitions and abbreviations 3.0 Applicability For the purposes of the present document, definitions and abbreviations have the meanings ascribed herein in clause 3. Where such meanings are not so ascribed the meanings in ETSI EN 301 489-1 1, clause 3, apply. W

44、here such meanings are not so ascribed the meanings in ETSI EN 301 839 2, clause 3, apply. Where such meanings are not so ascribed the meanings in the Directive 2014/53/EU i.1 apply. 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Active Medical I

45、mplant (AMI): diagnostic or therapeutic device designed to be implanted in a human body containing a power source and a transceiver using the 402 MHz to 405 MHz frequency band for the purpose of providing a two-way digital communications link environmental profile: range of environmental conditions

46、under which equipment within the scope of the present document is required to comply with the provisions of the present document life supporting equipment: equipment whose continued normal operation is required in order to sustain life Medical Implant Communications Link (MICL): collections of trans

47、mission that may or may not be continuous, between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient related information in communications service ETSI ETSI EN 301 489-27 V2.1.1 (2016-12)8 Medical Implant Communications System (MICS): specif

48、ic system providing radiocommunications between an ULP-AMI and an associated ULP-AMI-P Ultra Low Power Active Medical Implant (ULP-AMI): transmitter or receiver or transceiver forming part of an active medical implant, that is used in a medical implant communications system radio link set up by the

49、peripheral device (ULP-AMI-P) Ultra Low Power Active Medical Implant Peripheral device (ULP-AMI-P): radio part of equipment outside the human body, including body worn devices, used to program and/or control an ULP-AMI by means of a Medical Implant (radio) Communications Link (MICL), such as an external programmer or control transceiver 3.2 Abbreviations For the purposes of the present document, the following abbreviations apply: AC Alternating Current AIMD Active Implantable Medical Device AMI Active Medical Implant