1、 ETSI EN 301 489-31 V1.1.1 (2005-09)Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 31: Specific conditions for equipmentin the 9 kHz to
2、315 kHz band forUltra Low Power Active Medical Implants (ULP-AMI)and related peripheral devices (ULP-AMI-P)ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 2 Reference DEN/ERM-EMC-230-31 Keywords EMC, LF, radio, regulation, short range ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE Tel.
3、: +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 Individual copies of the present document can be downloaded from: http:/www.etsi.org The present document may be made a
4、vailable in more than one electronic version or in print. In any 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 o
5、n 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 at http:/portal.etsi.org/tb/status/status.asp If you fin
6、d errors in the present document, please send your comment to 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
7、 in all media. European Telecommunications Standards Institute 2005. All rights reserved. DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTMand the TIPHON logo are Trade Marks currently being registered by ETSI for the benefit of its Members. 3
8、GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 3 Contents Intellectual Property Rights5 Foreword.5 1 Scope 6 2 References 6 3 Definitions and abbreviations.7 3.1 Definitions7 3.2 Abbreviations
9、.7 4 Test conditions .8 4.1 General .8 4.2 Arrangements for test signals .8 4.2.1 Arrangements for test signals at the input of the transmitter 8 4.2.2 Arrangements for test signals at the output of the transmitter 8 4.2.2.1 ULP-AMI transmitters 8 4.2.2.2 ULP-AMI-P transmitters.8 4.2.3 Arrangements
10、for test signals at the input of the receiver.9 4.2.4 Arrangements for test signals at the output of the receiver.9 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) .9 4.3 Exclusion bands9 4.3.1 Exclusion bands for receiver
11、s .10 4.3.2 Exclusion band for transmitters 10 4.4 Narrow band responses of receivers.10 4.5 Normal test modulation10 5 Performance assessment.11 5.1 General .11 5.2 Equipment which can provide a continuous communications link 11 5.3 Equipment which does not provide a continuous communications link.
12、11 5.4 Ancillary equipment .11 5.5 Equipment classification 11 6 Performance criteria .12 6.1 Classification of ULP-AMI and ULP-AMI-P 12 6.2 General performance criteria12 6.3 Performance criteria and table12 6.4 Performance criteria for continuous phenomena applied to transmitters .13 6.5 Performan
13、ce criteria for transient phenomena applied to transmitters .13 6.6 Performance criteria for continuous phenomena applied to receivers14 6.7 Performance criteria for transient phenomena applied to receivers14 7 Applicability overview.14 7.1 Emission.14 7.1.1 General14 7.1.2 Special conditions.14 7.2
14、 Immunity 14 7.2.1 General15 7.2.2 Special conditions.15 Annex A (normative): Definitions of types of ULP-AMI and ULP-AMI-P in the scope of the present document.18 A.1 ULP-AMI and ULP-AMI-P intended for operation in the frequency range 9 kHz to 315 kHz.18 Annex B (informative): Test fixture for ULP-
15、AMI (Simulated man) .19 ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 4 Annex C (informative): Simultaneous testing of ULP-AMI/ULP-AMI-P and parts covered by AIMD 21 Annex D (informative): The EN title in the official languages .22 Annex E (informative): Bibliography.24 History 25 ETSI ETSI EN 301 489-31
16、 V1.1.1 (2005-09) 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 be found in ETSI SR 000 314: “I
17、ntellectual 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 (http:/webapp.etsi.org/IPR/home.asp). Pursuant to the ETSI IPR Policy, no in
18、vestigation, 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 This Candidate Har
19、monized European Standard (Telecommunications series) has 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 Council Directive 98/3
20、4/EC 4 (as amended) laying down a procedure for the provision of information in the field of technical standards and regulations. 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
21、 the Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (“the R ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common tec
22、hnical requirements“. 2 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active
23、Medical Implants (ULP-AMI) and accessories; Part 1: Technical characteristics and test methods“. 6 ETSI EN 302 195-2 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI
24、) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R - the manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the medical implant communications link. ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 9 4.2.3 Arrangeme
25、nts for test signals at the input of the receiver The provisions of EN 301 489-1 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); -
26、 the level of the wanted RF input signal shall be sufficiently above the threshold sensitivity level to provide reliable communication of the receiver, but in all cases it shall be below the overload characteristics of the receiver; - the manufacturer shall provide a suitable transmitter that can be
27、 used to set up the medical implant communications link if needed. 4.2.4 Arrangements for test signals at the output of the receiver The provisions 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 ULP-AMI and
28、associated ULP-AMI-P is not possible, then the manufacturer shall provide the method by which the receivers functionality can be monitored during the immunity tests. 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) The prov
29、isions of EN 301 489-1 1, clause 4.2.5 shall apply with the following modification: The transmitter of an ULP-AMI and the receiver of an associated ULP-AMI-P or the receiver of an ULP-AMI and the transmitter of an associated ULP-AMI-P may be tested together, if appropriate and agreed by the manufact
30、urer and the test laboratory (size of devices, etc.). In this case both EUTs shall be located in their respective test environment and exposed simultaneously to the EMC phenomena. 4.3 Exclusion bands The emission measurement and immunity test exclusions are referred to as “exclusion bands“ and are d
31、efined in the clauses 4.3.1 and 4.3. The frequency, on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequency on which the transmitter part of the EUT is intended to operate shall be excluded from emission measurements when performed in t
32、ransmit mode of operation. During emission measurements, a frequency exclusion band does not apply for the receiver part of ULP-AMIs and/or associated ULP-AMI-Ps. ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 104.3.1 Exclusion bands for receivers The exclusion band for receivers (including receivers that
33、 are part of transceivers) is determined as follows: - for receivers capable of operating on only one single frequency and not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used frequency channel minus the extension value given in table 1, and the
34、 upper frequency of the exclusion band is the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated extension value shall be based on the operating frequency; - for receivers capable of operating on more than one frequency and having an alignment ran
35、ge, the lower frequency of the exclusion band is the lower frequency of the alignment range minus the extension value given in table 1, and the upper frequency of the exclusion band is the upper frequency of the alignment range plus the extension value given in table 1. The calculated extension valu
36、es shall be based on the centre frequency of the alignment range; - for wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the exclusion band is the lower frequency of the intended operating band minus the extension value given in table 1 and the u
37、pper frequency of the exclusion band is the upper frequency of the intended operating band plus the extension value given in table 1, or the total exclusion band is twice the intended operating frequency band of the receiver centred around the centre frequency of the intended operating band, whichev
38、er is the greater. Table 1: Exclusion bands for the receiver part of ULP-AMI or ULP-AMI-Ps Receiver operating frequency foReceiver exclusion bands Receiver Class 1 Receiver Class 2 Receiver Class 3 9 kHz to 315 kHz fo 200 kHz (see note) fo 315 kHz (see note) fo 315 kHz (see note) NOTE: Measurements
39、shall not be carried out below 150 kHz. 4.3.2 Exclusion band for transmitters For wide band transmitters, i.e. transmitters in a non-channelized frequency band, the exclusion band is twice the intended operating frequency band (i.e. 315 kHz or less) centred on the centre frequency of the intended op
40、erating frequency band. In case the receiver and transmitter are tested together as a system (see clause 4.2.5) the exclusion band defined for receivers or the exclusion band defined for transmitters shall be used, whichever is greater. 4.4 Narrow band responses of receivers The provision of EN 301
41、489-1 1, clause 4.4 shall apply. 4.5 Normal test modulation The RF carrier shall be modulated with a test signal that produces specific selective messages or commands as stated by the manufacturer, representing a practical selection of usable selective messages/commands. The manufacturer shall decla
42、re the format of the modulation signal and any error detection and correction involved. Where transmitters do not have a modulation input port, the internal equipment modulation is used. ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 115 Performance assessment 5.1 General The provision of EN 301 489-1 1,
43、clause 5.1 shall apply. The manufacturer shall at the time of submission of the device(s) for test, supply the necessary general information as requested in EN 301 489-1 1, clause 5.1. Additionally he shall supply the following product-related information: - the class of the device selected by the m
44、anufacturer according to table 2 (see clause 6.1). The performance assessment is dependent on whether the type of device is an ULP-AMI or an ULP-AMI-P. For both types of devices the performance assessment is based on: - the maintenance of function(s); - the way an eventual loss of function(s) can be
45、 recovered; - the unintentional behaviour of the EUT. For both types of devices it shall be possible to assess the performance by monitoring the intended functions before, during and after the tests. 5.2 Equipment which can provide a continuous communications link The provisions of EN 301 489-1 1, c
46、lause 5.2 shall apply. 5.3 Equipment which does not provide a continuous communications link The provisions of EN 301 489-1 1, clause 5.3 shall apply. 5.4 Ancillary equipment The provisions of EN 301 489-1 1, clause 5.4 are not applicable. 5.5 Equipment classification The provisions of EN 301 489-1
47、1, clause 5.5 shall apply with the following modifications. For the purpose of EMC performance assessment in the present document, the radio devices/equipment and/or associated ancillary devices/equipment shall be classified into one of the following types: - ULP-AMI (implantable devices); or - ULP-
48、AMI-P (external peripheral devices used in conjunction with ULP-AMI). Life supporting devices shall meet the criteria specified for this type of device. Radio equipment declared as capable of being powered for intended use by the main battery of a vehicle shall additionally be considered as mobile e
49、quipment. ETSI ETSI EN 301 489-31 V1.1.1 (2005-09) 126 Performance criteria 6.1 Classification of ULP-AMI and ULP-AMI-P The product family of Active Implantable Medical Devices (AIMD) is divided into three sub-classes each having its own set of minimum performance criteria. This classification is based upon the impact on persons and/or goods in case the equipment does not operate above the specified minimum performance level under EMC stress. In lieu of using these classification guidelines, the manufacturer of ULP-AMI/ULP-AMI-P may declare the clas
