ETSI EN 301 489-35-2016 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services Part 35 Specific requirements for Low Power Active Medical Implants (LP-AMI) o_1.pdf

1、 ETSI EN 301 489-35 V2.1.1 (2016-12) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands; Harmonised Standard covering the essential requirements o

2、f article 3.1(b) of Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)2 Reference REN/ERM-EMC-338 Keywords EMC, harmonised standard, health, radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE Tel.: +33 4 92 94 42 00 Fax: +33

3、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 versions a

4、nd/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 the pr

5、int 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 available

6、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 any me

7、ans, 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. Eur

8、opean 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 Part

9、ners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI EN 301 489-35 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 7g33

10、 Definitions and abbreviations . 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 signals at the RF output of

11、transmitters . 9g34.2.2.0 General 9g34.2.2.1 ULP-AMI transmitters 9g34.2.2.2 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 . 10g34.2.5 Arrangements for testing transmitter and receiver t

12、ogether (as a system: ULP-AMI together with an associated ULP-AMI-P) . 10g34.3 RF exclusion band of radio equipment . 10g34.3.1 General 10g34.3.2 Exclusion band for receivers . 10g34.3.3 Exclusion band for transmitters 11g34.4 Narrow band responses of receivers or receivers which are part of transce

13、ivers . 11g34.5 Normal test modulation 11g35 Performance assessment . 11g35.1 General . 11g35.2 Equipment which can provide a continuous communication link 12g35.3 Equipment which does not provide a continuous communication link 12g35.4 Ancillary equipment . 12g35.5 Equipment classification 12g36 Pe

14、rformance criteria . 12g36.1 Classification of LP-AMI and LP-AMI-P devices . 12g36.2 General performance criteria 13g36.3 Performance criteria and table 13g36.4 Performance criteria for continuous phenomena applied to transmitters . 14g36.5 Performance criteria for transient phenomena applied to tra

15、nsmitters . 14g36.6 Performance criteria for continuous phenomena applied to receivers 15g36.7 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 Immunity 16g37.2.1 General 16g

16、37.2.2 Special conditions . 16g3ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)4 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 20g3Annex B (normative): Definitions of types of LP-AMI and LP-AMI-P devices in the scope of the present d

17、ocument . 22g3B.1 LP-AMI and LP-AMI-P devices intended for operation in the frequency range 2 483,5 MHz to 2 500 MHz 22g3Annex C (normative): Test fixture for LP-AMI devices (Simulated man) . 23g3History 25g3ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)5 Intellectual Property Rights IPRs essential or pot

18、entially 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 potentially Essentia

19、l, 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. No guarantee can

20、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 Committee Electromagnetic c

21、ompatibility 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 harmonisation of the laws of the Member

22、 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 given in table A.1 con

23、fers, 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 35 of a multi-part deliverable. Full details of the entire series can be found in ET

24、SI 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 any conflicting Nat

25、ional 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 for the expression

26、 of provisions). “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct citation. ETSI ETSI EN 301 489-35 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 with Low Power Active

27、Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of ElectroMagnetic Compatibility (EMC). The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral devices (LP-AMI-P). Technical specifications related to the antenna

28、port and emissions from the enclosure port of the radio system of LP-AMI and associated Peripheral devices (LP-AMI-P) 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

29、specifies the applicable test conditions, performance assessment, and performance criteria for of LP-AMI and associated Peripheral devices (LP-AMI-P). Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B. In case of differences (for instance concerning specia

30、l 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 in the ETSI EN 301 489-1 1, e

31、xcept 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 Normative references References

32、 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. Referenced documen

33、ts 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 following referenced documents a

34、re 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 of article 3.1(b) of Direct

35、ive 2014/53/EU and the essential 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 CENELEC EN 61000-4-5:2006: “Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement

36、 techniques - Surge immunity test“. 3 ETSI EN 301 559 (V2.1.1) (10-2016): “Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of

37、 article 3.2 of the Directive 2014/53/EU“. ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)7 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

38、-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 t

39、he 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 harmonisation of the laws of the Member States relating to the making available on the market of ra

40、dio 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 Commission Decision 2006/771/EC of 11 November 2006 on harmonization of the radio spectrum for use by short-range devices as amended by subsequent Commission Decisions. i.

41、4 http:/r.it/. i.5 Camelia Gabriel: “Compilation of the dielectric properties of body tissues at RF and Microwave Frequencies“, (Physics Department, Kings College, London WC2R 2LS, UK. i.6 Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request to the European Co

42、mmittee 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. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present documen

43、t, the terms and definitions given in ETSI EN 301 489-1 1, ETSI EN 301 559 3, Directive 2014/53/EU i.1 and the following apply: Active Implantable Medical Device (AIMD): any active medical device (AMD) which is intended to be totally or partially introduced, surgically or medically, into the human b

44、ody or by medical intervention into a natural orifice, and which is intended to remain after the procedure Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any source of power Active Medical Implant (AMI): diagnostic or therapeutic devic

45、e designed to be implanted in a human body containing a power source and a transceiver using the 2 483,5 MHz to 2 500 MHz frequency band for the purpose of providing a two-way digital communications link life supporting equipment: equipment whose continued normal operation is required in order to su

46、stain life Low Power Active Medical Implant (LP-AMI): low power radio part of any active medical device (AMD), which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain afte

47、r the procedure Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an equipment that communicates indoor with one or more LP-AMI to establish an AMICL NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described a

48、s “medical implant event“. ETSI ETSI EN 301 489-35 V2.1.1 (2016-12)8 Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be us

49、ed for human beings in the: diagnosis, prevention, monitoring, treatment or alleviation of disease or injury and for prolongation of life; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means Medical Implant Communications Link (MICL): collections of transmission that may or may not