SIST EN 301 489-31 V1.1.1:2006

Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)

The present document together with EN 301 489-1 [1] covers the assessment of all radio transceivers associated with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of ElectroMagnetic Compatibility (EMC). Non-radio parts of the above equipment may be covered by other directives and/or standards when applicable.
Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these devices 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 specifies the applicable test conditions, performance assessment, and performance criteria for assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps. In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and 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 EN 301 489-1 [1], except for any special conditions included in the present document.

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) – Standard elektromagnetne združljivosti (EMC) za radijsko opremo in storitve – 31. del: Posebni pogoji za opremo za aktivne medicinske vsadke ultra majhnih moči (ULP-AMI) in pripadajočih perifernih naprav (ULP-AMI-P), ki delujejo v frekvenčnem pasu od 9 kHz do 315 kHz

General Information

• Status: Published
• Publication Date: 28-Feb-2006
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 33.060.20 - Receiving and transmitting equipment
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: SS EIT - Technical Board for the electrotechnical, information technology and telecommunications fields
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Mar-2006
• Due Date: 01-Mar-2006
• Completion Date: 01-Mar-2006
• Directive: 1999/5/EC - 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
• Directive: TRRTP124 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-4)
• Mandate: M/284
• Mandate: M/322
• Ref Project: ETSI EN 301 489-31 V1.1.1 (2005-06) - Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 301 489-31 V1.1.1:2006
01-marec-2006
(OHNWURPDJQHWQD]GUXåOMLYRVWLQ]DGHYHY]YH]L]UDGLMVNLPVSHNWURP(50±
6WDQGDUGHOHNWURPDJQHWQH]GUXåOMLYRVWL(0&]DUDGLMVNRRSUHPRLQVWRULWYH±
GHO3RVHEQLSRJRML]DRSUHPR]DDNWLYQHPHGLFLQVNHYVDGNHXOWUDPDMKQLKPRþL
8/3$0,LQSULSDGDMRþLKSHULIHUQLKQDSUDY8/3$0,3NLGHOXMHMRY
IUHNYHQþQHPSDVXRGN+]GRN+]
Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 31: Specific
conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active
Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)
Ta slovenski standard je istoveten z: EN 301 489-31 Version 1.1.1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
33.060.20 Sprejemna in oddajna Receiving and transmitting
oprema equipment
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN 301 489-31 V1.1.1:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 301 489-31 V1.1.1:2006

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SIST EN 301 489-31 V1.1.1:2006

Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
Candidate Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 31: Specific conditions for equipment in the 9 to 315 kHz
band for Ultra Low Power Active Medical Implants (ULP-AMI)
and related peripheral devices (ULP-AMI-P)

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SIST EN 301 489-31 V1.1.1:2006
 2 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)



Reference
DEN/ERM-EMC-230-31
Keywords
EMC, LF, radio, regulation, short range
ETSI
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SIST EN 301 489-31 V1.1.1:2006
 3 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.6
3 Definitions and abbreviations.7
3.1 Definitions.7
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 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 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 bands.9
4.3.1 Exclusion bands for receivers .10
4.3.2 Exclusion band for transmitters .10
4.4 Narrow band responses of receivers.10
4.5 Normal test modulation.10
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 Classification of ULP-AMI and ULP-AMI-P .12
6.2 General performance criteria.12
6.3 Performance criteria and table.12
6.4 Performance criteria for continuous phenomena applied to transmitters .13
6.5 Performance criteria for transient phenomena applied to transmitters .13
6.6 Performance criteria for continuous phenomena applied to receivers.14
6.7 Performance criteria for transient phenomena applied to receivers.14
7 Applicability overview.14
7.1 Emission.14
7.1.1 General.14
7.1.2 Special conditions.14
7.2 Immunity.14
7.2.1 General.15
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-AMI (Simulated man) .19
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 4 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
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.23
History .24

ETSI

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SIST EN 301 489-31 V1.1.1:2006
 5 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
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: "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 (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 updates 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), and is now submitted for the Vote phase
of the ETSI standards Two-step Approval Procedure.
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 [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 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&TTE Directive" [2]).
The present document is part 31 of a multi-part deliverable. Full details of the entire series can be found in
EN 301 489-1 [1].

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa

ETSI

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SIST EN 301 489-31 V1.1.1:2006
 6 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
1 Scope
The present document together with EN 301 489-1 [1] covers the assessment of all radio transceivers associated with
inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from
9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of
9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of
ElectroMagnetic Compatibility (EMC). Non-radio parts of the above equipment may be covered by other directives
and/or standards when applicable.
Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these
devices 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 specifies the applicable test conditions, performance assessment, and performance criteria for
assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps.
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and 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 EN 301 489-1 [1], except for any special conditions included in the present document.
2 References
The following documents contain provisions which, through reference in this text, constitute provisions of the present
document.
• References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• For a non-specific reference, the latest version applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
[1] ETSI EN 301 489-1: "Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and 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&TTE Directive).
[3] IEC 60417-DB-12M: "Graphical symbols for use on equipment - 12-month subscription to online
database comprising all graphical symbols published in IEC 60417".
[4] Directive 98/34/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.
[5] ETSI EN 302 195-1 (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) 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) and accessories; Part 2: Harmonized EN covering essential requirements of
article 3.2 of the R&TTE Directive".
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 7 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
[7] CENELEC EN 60601-1-2: "Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests".
[8] ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[9] CENELEC EN 61000-4-5: "Electromagnetic compatibility (EMC) - Part 4-5: Testing and
measurement techniques - Surge immunity test".
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in EN 301 489-1 [1] and the following apply:
emission bandwidth: bandwidth between two points that are 20 dB down on either side of the frequency with the
maximum level in the modulation envelope
environmental profile: range of environmental conditions under which equipment within the scope of EN 301 489-31
is required to comply with the provisions of EN 301 489-31
H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the field
can be measured
life supporting equipment: equipment or system that includes at least one function that is intended to actively keep
alive or resuscitate patients and the failure of which is likely to lead to serious injury or death of a patient
Medical Implant Communications Link (MICL): collections of transmission that may or may not be continuous,
between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient
related information in communications service
non-radio part: those portions of a device not used for communication via electromagnetic waves
radio part: that portion of a device used for communication via electromagnetic waves
Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an active medical implant
Ultra Low Power Active Medical Implant Peripheral device (ULP-AMI-P): radio part of equipment outside the
human body, including body worn devices and monitors, used to program and/or control or receive data from an
ULP-AMI
3.2 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AIMD Active Implantable Medical Device
AMI Active Medical Implant
EMC ElectroMagnetic Compatibility
EUT Equipment Under Test
MICL Medical Implant Communications Link
R&TTE Radio and Telecommunications Terminal Equipment
ULP-AMI Ultra Low Power-Active Medical Implant
ULP-AMI-P Ultra Low Power-Active Medical Implant Peripheral device
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 8 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
4 Test conditions
For the purposes of the present document, the test conditions of EN 301 489-1 [1], clause 4 shall apply as appropriate.
Further product related test conditions for equipment covered by the scope of the present document are specified herein.
4.1 General
For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present
document, clauses 4.1 to 4.5 shall apply.
Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the
antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with
several types of antenna the test shall be repeated for each type of antenna.
Active Medical Implant inductive devices are designed to be implanted within a human body. These radio systems are
isolated from disturbances by the surrounding body tissue. In order to adequately assess the EMC characteristics of
active medical implants devices as they are intended to be used, the use of a simulated man is permitted. See annex B
for additional details. The provisions of annex B are intended to provide an operational environment that simulates, to
the extent possible, actual usage conditions for internal implanted devices. It may be necessary to use this or another
appropriate special fixture when making emission measurements and immunity tests with radiated RF fields.
4.2 Arrangements for test signals
The provisions of the EN 301 489-1 [1], clause 4.2 shall apply.
4.2.1 Arrangements for test signals at the input of the transmitter
The provisions of the EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications:
The transmitter shall be modulated with normal test modulation as specified for that type of equipment
(clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall
be used.
4.2.2 Arrangements for test signals at the output of the transmitter
The provisions of the EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification:
The manufacturer may provide a suitable companion receiver or another device that can be used to set up a
communications link and/or to receive messages.
4.2.2.1 ULP-AMI transmitters
For ULP-AMI transmitters the test fixture described in annex B may be used.
The manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the medical
implant communications link.
4.2.2.2 ULP-AMI-P transmitters
The provisions of the EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications:
- ULP-AMI-Ps are designed to be used external to a human body;
- the manufacturer shall provide a suitable receiver or alternate technique that can be used to monitor the
medical implant communications link.
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 9 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
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
specified for that type of equipment (clause 4.5);
- 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 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 associated ULP-AMI-P is not possible, then the
manufacturer shall provide the method by which the receiver's 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 provisions 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 manufacturer 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 defined 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 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.
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 10 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
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 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 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 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
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 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 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 Receiver exclusion bands
frequency f
o
Receiver Class 1 Receiver Class 2 Receiver Class 3
9 kHz to 315 kHz f ± 200 kHz (see note) f ± 315 kHz (see note) f ± 315 kHz (see note)
o o o
NOTE: Measurements 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 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 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 that produces specific selective messages or commands as 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 modulation is used.
ETSI

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SIST EN 301 489-31 V1.1.1:2006
 11 Final draft ETSI EN 301 489-31 V1.1.1 (2005-06)
5 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 [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 type of device is an ULP-AMI or an ULP-AMI-P.
For both types of devices the performance assessmen
...