1、 ETSI EN 301 489-27 V1.1.1 (2004-06)Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 27: Specific conditions for Ultra Low PowerActive Med
2、ical Implants (ULP-AMI)and related peripheral devices (ULP-AMI-P)ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 2 Reference DEN/ERM-EMC-235-27 Keywords EMC, radio, regulation, RTTT, short range ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE Tel.: +33 4 92 94 42 00 Fax: +33 4 93 65 47
3、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 available in more than one electronic ver
4、sion 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 on a specific network drive within ETSI S
5、ecretariat. 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 find errors in the present document, send y
6、our comment to: editoretsi.org 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 2004. All rights reserved. DECTTM, PLUGTESTSTM
7、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. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partner
8、s. ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 3 Contents Intellectual Property Rights5 Foreword.5 1 Scope 6 2 References 6 3 Definitions and abbreviations.7 3.1 Definitions7 3.2 Abbreviations .7 4 Test conditions .8 4.1 General .8 4.2 Arrangements for test signals .8 4.2.1 Arrangements for test signal
9、s 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 for test signals at the input of the receiver.9 4.2.4 Arrangements for test signals at the output of the recei
10、ver.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 receivers .9 4.3.2 Exclusion band for transmitters 10 4.4 Narrow band responses of receivers.10 4.5 Normal test modula
11、tion10 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.11 5.4 Ancillary equipment .11 5.5 Equipment classification 11 6 Performance criteria .12 6.1 Sub-classificatio
12、n of ULP-AMI and ULP-AMI-P devices.12 6.2 General performance criteria12 6.3 Performance criteria and table12 6.4 Performance criteria for continuous phenomena applied to transmitters .14 6.5 Performance criteria for transient phenomena applied to transmitters .14 6.6 Performance criteria for contin
13、uous phenomena applied to receivers14 6.7 Performance criteria for transient phenomena applied to receivers14 7 Applicability overview.15 7.1 Emission.15 7.1.1 General15 7.1.2 Special conditions.15 7.2 Immunity 15 7.2.1 General15 7.2.2 Special conditions.15 Annex A (normative): Definitions of types
14、of ULP-AMI and ULP-AMI-P devices in the scope of the present document19 A.1 ULP-AMI and ULP-AMI-P devices intended for operation in the frequency range 402 MHz to 405 MHz.19 Annex B (normative): Test fixture for ULP-AMI devices (Simulated man) 20 ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 4 Annex C (i
15、nformative): Bibliography.22 Annex D (informative): The EN title in the official languages .23 History 24 ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 5 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining
16、 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 Essential, IPRs notified to ETSI in respect of ETSI standards“, which is available from the ETSI Secretariat.
17、 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 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 up
18、dates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This Candidate Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The pre
19、sent document has been produced by ETSI in response to a mandate from the European Commission issued under the Council Directive 98/34/EC 4 (as amended) laying down a procedure for the provision of information in the field of technical standards and regulation. The present document, together with EN
20、 301 489-1 1, is intended to become a Harmonized Standard, the reference of which will be published in the Official Journal of the European Communities referencing the Council Directive on the approximation of the laws of the Member States relating to electromagnetic compatibility (“the EMC Directiv
21、e“) (89/336/EEC 3 as amended), and 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 an
22、d services; Part 1: Common technical 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 402 MHz to 405
23、 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods“. 6 ETSI EN 301 839-2 (V1.1.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequenc
24、y range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R - the manufacturer shall provide a suitable receiver that can be used to monitor the medical implant communications link. ETSI ETSI EN
25、 301 489-27 V1.1.1 (2004-06) 9 4.2.3 Arrangements 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 specif
26、ied for that type of equipment (clause 4.5); - the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level 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 c
27、an be used to set up the medical implant communications link. 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 ass
28、ociated 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 provisi
29、ons 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 manufactu
30、rer 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 def
31、ined in the clauses 4.3.1 and 4.3.2 of the present document. The frequencies on which the EUT is intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequencies on which the transmitter part of the EUT is intended to operate shall be excluded from emission measu
32、rements when performed in transmit 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. 4.3.1 Exclusion bands for receivers The exclusion band for receivers (including receivers that are part of tra
33、nsceivers) is determined as follows: - for receivers capable of operating on 9 or more channels within the frequency band specified in table 1 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 g
34、iven in table 1, and the 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; ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 10- for receivers capable
35、of operating on more than one frequency and having an alignment range, 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
36、the extension value given in table 1. The calculated extension values 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
37、operating band minus the extension value given in table 1 and the upper 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
38、around the centre frequency of the intended operating band, whichever 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 3 402 MHz to 405 MHz fo 10 MHz fo (5
39、% x fo) fo (5 % x fo) 4.3.2 Exclusion band for transmitters For transmitters operating, or intended to operate, in a channelized arrangement in the 402 MHz to 405 MHz frequency band, the exclusion band is nine times the maximum occupied bandwidth allowed for that service, centred around the operatin
40、g frequency. For the 402 MHz to 405 MHz band, the maximum occupied bandwidth is 300 kHz. The actual occupied bandwidth is determined using the procedures in EN 301 839-1 5 for measuring emission bandwidth. For wide band transmitters, i.e. transmitters in a non-channelized frequency band, the exclusi
41、on band is twice the intended operating frequency band (i.e. 3 MHz or less) centred around the centre frequency of the intended operating 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
42、band defined for transmitters shall be used, whichever is greater. 4.4 Narrow band responses of receivers The provision of EN 301 489-1 1, clause 4.4 shall apply. 4.5 Normal test modulation The RF carrier shall be modulated with a test signal which produces specific selective messages or commands as
43、 stated by the manufacturer, representing a practical selection of usable selective messages/commands. The manufacturer shall declare 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 mo
44、dulation is used. ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 115 Performance assessment 5.1 General The provision of EN 301 489-1 1, 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
45、 1, clause 5.1. Additionally he shall supply the following product-related information: - the class of the device selected by the manufacturer according to table 2 (see clause 6.1). The performance assessment is dependent on whether the device is an ULP-AMI or an ULP-AMI-P. For both types of devices
46、 the performance assessment is based on: - the maintenance of function(s); - the way an eventual loss of function(s) can be 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, durin
47、g and after the tests. 5.2 Equipment which can provide a continuous communications link The provisions of EN 301 489-1 1, clause 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 Th
48、e provisions of EN 301 489-1 1, clause 5.4 are not applicable. 5.5 Equipment classification The provisions of EN 301 489-1 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 associate
49、d ancillary devices/equipment shall be classified into one of the following types: - ULP-AMI (implantable devices); or - ULP-AMI-P (external peripheral devices). - 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 equipment. ETSI ETSI EN 301 489-27 V1.1.1 (2004-06) 126 Performance criteria 6.1 Sub-classification of ULP-AMI and ULP-AMI-P devices The product family of
