ETSI EN 301 489-29-2016 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services Part 29 Specific conditions for Medical Data Service Devices (MEDS) operating _1.pdf

1、 ETSI EN 301 489-29 V2.1.1 (2016-12) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; Harmonised Standard covering the essential requir

2、ements of article 3.1(b) of Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)2 Reference REN/ERM-EMC-336 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

3、 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 document may be made available in electron

4、ic 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 and/or in print, the only prevailing docum

5、ent is the 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

6、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 part may be reproduced or utilized in any form

7、 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 foregoing restriction extend to reproduction in a

8、ll 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 benefit of its Members and of the 3GPP Organi

9、zational Partners. GSM and the GSM logo are Trade Marks registered and owned by the GSM Association. ETSI ETSI EN 301 489-29 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 re

10、ferences 7g33 Definitions and abbreviations . 7g33.1 Definitions 7g33.2 Abbreviations . 8g34 Test conditions . 9g34.1 General . 9g34.2 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

11、RF output of transmitters . 9g34.2.2.0 General 9g34.2.2.1 ULP- AMI and ULP-BWD transmitters . 10g34.2.2.2 ULP-AMI-P, ULP-AMD and ULP-AMD-P transmitters . 10g34.2.3 Arrangements for test signals at the RF input of receivers . 10g34.2.4 Arrangements for test signals at the output of receivers . 10g34.

12、2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) . 10g34.3 RF exclusion band of radio equipment . 10g34.3.1 General 10g34.3.2 Exclusion bands for receivers . 11g34.3.3 Exclusion band for transmitters 11g34.4 Narrow band respo

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

14、ry equipment . 12g35.5 Equipment classification 12g36 Performance criteria . 13g36.1 Class of ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P devices covered by the present document 13g36.2 General performance criteria 13g36.3 Performance criteria and table 13g36.4 Performance criteria for contin

15、uous phenomena applied to transmitters . 15g36.5 Performance criteria for transient phenomena applied to transmitters . 15g36.6 Performance criteria for continuous phenomena applied to receivers 15g36.7 Performance criteria for transient phenomena applied to receivers 15g37 Applicability overview .

16、16g37.1 EMC emission 16g37.1.1 General 16g37.1.2 Special conditions . 16g37.2 Immunity 16g37.2.1 General 16g37.2.2 Special conditions . 17g3ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)4 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU

17、. 20g3Annex B: Void 22g3Annex C (normative): Test fixture for Implanted (ULP-AMI) and Body Worn Devices (ULP-BWD) 23g3C.1 Equipment in close proximity to the human body but external to it and devices intended to be implanted in the body . 23g3C.2 Human torso simulator for ULP-BWD and ULP-AMI 23g3His

18、tory 25g3ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)5 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-members, and can

19、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/). Pursuant to the ETSI

20、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 document. Foreword T

21、his 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 means of conforming

22、 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 European Union under

23、 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 regulations. The present

24、document is part 29 of a multi-part deliverable. Full details of the entire series can be found in part 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 e

25、ndorsement of this EN (dop/e): 30 September 2017 Date of withdrawal of 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 interpre

26、ted 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 citation. ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)6 1 Scope The present document together with ETSI EN 301

27、489-1 1, covers the assessment of all radio transceivers associated with Ultra Low Power Active Medical Implants (ULP-AMIs), Ultra Low Power Active Medical Devices (ULP-AMDs), Ultra Low Power Body Worn Devices (ULP-BWDs) and associated Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-Ps),

28、 Ultra Low Power Active Medical Device Peripherals (ULP-AMD-Ps) in respect of ElectroMagnetic Compatibility (EMC). The radio link may be part of life supporting or non life supporting equipment and can be classified independently of the classification of the medical portion of the device. The presen

29、t document covers the EMC requirements for the radio functions of ultra low power implanted, body worn and associated ultra low power peripheral devices. Technical specifications related to the antenna port and emissions from the enclosure port of these radio system devices are not included in the p

30、resent document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document applies to ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices with RF power levels ranging up to 25 W ERP and intended for operation in

31、 the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz in accordance with the provisions of annex 12, band b) and band c), to CEPT/ERC/REC 70-03 i.3. Definitions of such ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P radio devices are found in the following functional radio standard: ETS

32、I EN 302 537 2: “Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU“. In case of differences (for instance concerning specia

33、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

34、xcept for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 1, are aimed to cover requirements to demonstrate an adequate level of electromagnetic compatibility. 2 References 2.1 Normative references References are either specific (identif

35、ied 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

36、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 applicat

37、ion 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 essent

38、ial 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. ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)7 2 ETSI EN 302 537 (V2.1.1) (10-2016): “Ultra Low Power Medical Data Service (MEDS) Syste

39、ms operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU“. 3 CENELEC EN 61000-4-5 (2006): “Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Sur

40、ge immunity test“. 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 documen

41、t (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 the application of the present document but they assist the user wi

42、th 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 radio equipment and repealing Directive 1999/5/EC. i.2 Directive 98/

43、34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. i.3 CEPT/ERC/Recommendation 70-03: “Relating to the use of Short Range Devices (SRD)“. i.4 Council Directive 93/42/EEC of

44、14 June 1993 concerning medical devices. 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 ETSI EN 301 489 (all parts): “Electromagnetic compatibility and Radio spectrum Matte

45、rs (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services“. i.7 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 I

46、nstitute 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 document, the terms and definitions given in ETSI EN 301 489-1 1, ETSI EN 302 537 2, Directive 2014/53

47、/EU i.1 and the following apply: ancillary equipment: See definition in ETSI EN 301 489-1 1. environmental profile: range of environmental conditions under which equipment within the scope of each part the multi-part deliverable ETSI EN 301 489 i.6 is required to comply with the provisions of ETSI E

48、N 301 489-1 1 life supporting equipment: equipment whose continued normal operation is required in order to sustain life Medical Data Service (MEDS): service that uses a system specifically for the purpose of providing non-voice digital communications between active medical implants and/or body worn

49、 devices and other devices external to the human body engaged in transferring non-time critical individual patient related physiological information ETSI ETSI EN 301 489-29 V2.1.1 (2016-12)8 Medical Data Service (MEDS) System Communication Link (MEDSCL): collection of transmissions that may or may not be continuous, between MEDS system devices including at least one active medical implant or body worn device together with other devices external to the body engaged in transferring non-time critical patient related physiolo