1、 ETSI EN 301 489-29 V1.1.1 (2009-02)Harmonized European Standard (Telecommunications series) Electromagnetic compatibility andRadio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 29: Specific conditions for Medical Data ServiceDevices (MEDS)
2、 operating in the 401 MHz to 402 MHzand 405 MHz to 406 MHz bandsETSI ETSI EN 301 489-29 V1.1.1 (2009-02)2Reference DEN/ERM-EMC-237-29 Keywords EMC, radio, regulation 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 348 623 562
3、 00017 - NAF 742 C Association but non lucratif enregistre la Sous-Prfecture de Grasse (06) N 7803/88 Important notice Individual copies of the present document can be downloaded from: http:/www.etsi.org The present document may be made available in more than one electronic version or in print. In a
4、ny case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secretariat. Users of t
5、he 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 at http:/portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to
6、one of the following services: http:/portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media. European Telecommunications Standards Institute
7、 2009. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. LTE is a Trade Mar
8、k of ETSI currently being registered for the benefit 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 301 489-29 V1.1.1 (2009-02)3Contents Intellectual Property Rights 5g3Foreword . 5g31 Scope 6g32
9、References 6g32.1 Normative references . 7g32.2 Informative references 7g33 Definitions and abbreviations . 7g33.1 Definitions 7g33.2 Abbreviations . 8g34 Test conditions . 9g34.1 General . 9g34.2 Arrangements for test signals . 9g34.2.1 Arrangements for test signals at the input of the transmitter
10、9g34.2.2 Arrangements for test signals at the output of the transmitter 9g34.2.2.1 ULP- AMI and ULP-BWD transmitters . 9g34.2.2.2 ULP-AMI-P, ULP-AMD and ULP-AMD-P transmitters . 10g34.2.3 Arrangements for test signals at the input of the receiver . 10g34.2.4 Arrangements for test signals at the outp
11、ut of the receiver . 10g34.2.5 Arrangements for testing individual transmitters and receivers that are intended to operate together in a MEDS system 10g34.3 Exclusion bands 10g34.3.1 Exclusion bands for receivers . 11g34.3.2 Exclusion band for transmitters 11g34.4 Narrow band responses of receivers
12、. 11g34.5 Normal test modulation 11g35 Performance assessment . 12g35.1 General . 12g35.2 Equipment which can provide a continuous communications link 12g35.3 Equipment which does not provide a continuous communications link . 12g35.4 Ancillary equipment . 12g35.5 Equipment classification 12g36 Clas
13、sification and 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 continuous phenomena applied to transmitters .
14、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 . 16g37.1 Emission . 16g37.1.1 General 16g3
15、7.1.2 Special conditions . 16g37.2 Immunity 16g37.2.1 General 16g37.2.2 Special conditions . 16g3Annex A (normative): Definitions of types of ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices in the scope of the present document 20g3ETSI ETSI EN 301 489-29 V1.1.1 (2009-02)4A.1 ULP-AMI, ULP-
16、AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices intended for operation in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz 20g3Annex B (normative): Test fixture for Implanted (ULP-AMI) and Body Worn Devices (ULP-BWD) 21g3B.1 Equipment in close proximity to the human body but external to i
17、t and devices intended to be implanted in the body . 21g3B.2 Human torso simulator for ULP-BWD and ULP-AMI 21g3Annex C (informative): The EN title in the official languages . 24g3Annex D (informative): Bibliography . 25g3History 26g3ETSI ETSI EN 301 489-29 V1.1.1 (2009-02)5Intellectual Property Righ
18、ts 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); Essential,
19、 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 (http:/webapp.etsi.org/IPR/home.asp). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been
20、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 This Harmonized European Standard (Telecommunications series) ha
21、s been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been produced by ETSI in response to a mandate from the European Commission issued under the Council Directive 98/34/EC i.2 (as amended) laying down a procedure for th
22、e provision of information in the field of technical standards and regulation. The present document is intended to become a Harmonized Standard, the reference of which will be published in the Official Journal of the European Communities referencing the Directive 1999/5/EC i.1 of the European Parlia
23、ment and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (“the R - for informative references. Referenced documents which are not found to be publicly available in the expected location might be found at http:
24、/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. 2.1 Normative references The following referenced documents are indispensable for the application of the present document. For dated re
25、ferences, only the edition cited applies. For non-specific references, the latest edition of the referenced document (including any amendments) applies. 1 ETSI EN 301 489-1 (V1.8.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for rad
26、io equipment and services; Part 1: Common technical requirements“. ETSI ETSI EN 301 489-29 V1.1.1 (2009-02)72 ETSI EN 302 537-1 (V1.1.2): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequenc
27、y range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 1: Technical characteristics and test methods“. 3 ETSI EN 302 537-2 (V1.1.2): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency ra
28、nge 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R ElectroMagnetic Compatibility (EMC) standard for radio equipment and services“. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present document, the t
29、erms and definitions given in EN 301 489-1 1 and the following apply: ancillary equipment: See definition in EN 301 489-1 1. environmental profile: range of environmental conditions under which equipment within the scope of each part the multi-part deliverable EN 301 489 i.6 is required to comply wi
30、th the provisions of EN 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 imp
31、lants and/or body worn 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 V1.1.1 (2009-02)8Medical Data Service (MEDS) System Communication Link (MEDSCL): collection of transmissi
32、ons 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 physiological information collected by a single MEDS system
33、Medical Data Service (MEDS) communication session: collection of transmissions that may or may not be continuous, between co-operating ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P Medical Data Service(MEDS) System: collection of medical devices having RF transmitting capability, that are assoc
34、iated with a specific patient that have the ability to communicate with each other using frequencies in the 401 MHz to 402 MHz and/or 405 MHz to 406 MHz bands Medical Data Service (MEDS) System Communication Channel: any continuous segment of spectrum that is equal to the emission bandwidth of the d
35、evice with the largest bandwidth that is to participate in a MEDS session NOTE: As stated in CEPT/ERC/REC 70-03 i.3, annex 12 Bands a1) and a2), it is permitted to aggregate 25 kHz segments up to a maximum of 100 kHz for each channel bandwidth. Medical Data Service (MEDS) System Device: any ultra lo
36、w power medical device transmitting in the 401 MHz to 402 MHz and/or 405 MHz to 406 MHz band. Only two types of MEDS system devices are permitted under the present document: Frequency agile devices that are designed to access a minimum of 18 channels evenly distributed across the 401 MHz to 402 MHz
37、and 405 MHz to 406 MHz bands with a minimum of 9 channels defined for each 1 MHz segment (i.e. 401 MHz to 402 MHz and 405 MHz to 406 MHz) Devices capable of operation only on a single channel using low duty cycle and low power for spectrum access in the 401 MHz to 402 MHz and 405 MHz to 406 MHz band
38、s, see clause 8.6 Ultra Low Power Active Medical Device (ULP-AMD): radio part of a medical device that is also regulated under 93/42/EEC i.4 Ultra Low Power Active Medical Device Peripheral (ULP-AMD-P): radio part of medical equipment outside the human body that communicates with an ULP-AMD, ULP-BWD
39、 or other ULP-AMD-P that is part of a MEDS communication system Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: radio part of medical equipment outside the human body that communicates with an ULP-AMI to es
40、tablish a medical implant communications link Ultra Low Power Body Worn Device (ULP-BWD): radio part of a medical device, such as a physiological parameter sensor or handheld device, that is intended to operate in very close proximity to the human body, including touching the body, which has its rad
41、io antenna external to the body 3.2 Abbreviations For the purposes of the present document, the following abbreviations apply: AIMD Active Implantable Medical Devices BWD Body Worn Devices EMC ElectroMagnetic Compatibility EUT Equipment Under Test MEDS Medical Data Service MEDSCL Medical Data Servic
42、e System Communications Link R the provider shall provide a suitable receiver or other equipment that can be used to monitor the medical system communications link. ETSI ETSI EN 301 489-29 V1.1.1 (2009-02)104.2.3 Arrangements for test signals at the input of the receiver The provisions of EN 301 489
43、-1 1, clause 4.2.3 shall apply with the following modifications: the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as specified for that type of equipment (clause 4.5); the level of the wanted RF input signal shall be 20 dB above the threshold sensit
44、ivity level of the receiver, but in all cases it shall be below the overload characteristics of the receiver; the provider shall provide a suitable transmitter that can be used to set up the medical implant communications link. 4.2.4 Arrangements for test signals at the output of the receiver The pr
45、ovisions of EN 301 489-1 1, clause 4.2.4 shall apply with the following modification, if appropriate: if direct access to the receiver output of the devices covered by the present document is not possible, then the provider shall provide the method by which the receivers functionality can be monitor
46、ed during the immunity tests. 4.2.5 Arrangements for testing individual transmitters and receivers that are intended to operate together in a MEDS system The provisions of EN 301 489-1 1, clause 4.2.5 shall apply with the following modification: the transmitter and the receiver of each device intend
47、ed to operate in a MEDS system may be tested together, if appropriate and agreed to by the provider and the test laboratory. In this case all EUTs shall be located in their respective test environment and exposed simultaneously to the EMC phenomena. 4.3 Exclusion bands The emission measurement and i
48、mmunity test exclusions are referred to as “exclusion bands“ and are defined in the clauses 4.3.1 and 4.3.2 of the present document. The frequencies on which the EUT(s) is(are) intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequencies on which the transmit
49、ter part of the EUT(s) is(are) intended to operate shall be excluded from emission measurements when performed in transmit mode of operation. During emission measurements, a frequency exclusion band does not apply for the receiver part of the equipment covered by the present document. 4.3.1 Exclusion bands for receivers The exclusion band for receivers (including receivers that are part of transceivers) is determined as follows: - For receivers capable of operating on only one single frequency the lower frequency of the exclusion b
