SIST EN 302 195-1 V1.1.1:2006

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

The present document applies to Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated radio apparatus transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not within the scope of the present document. The present document contains the technical characteristics and test methods for radio equipment and is referenced in CEPT/ERC Recommendation 70-03 [2], annex 12 band(b). The present document does not necessarily include all the characteristics which may be required by a user, nor does it necessarily represent the optimum performance achievable. It is a product standard which may be completely or partially superseded by specific standards covering specific applications.
The present document applies to ULP-AMI transceivers conforming to the following:
- inductive loop systems;
- with an antenna connection and/or with an integral antenna;
- for use as telecommunications and telecommand transmission to/from active medical implants.
ULP-AMI equipment has an inherent safety of human life implication, manufacturers and users are cautioned to pay particular attention to the potential for interference from other systems operating in the same or adjacent bands. The present document covers physician operated programmer/controllers transmitters (typically fixed stations), patient operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations). All types of digital modulation for radio devices are covered by the present document.
The radio equipment, covered by the classification SRD is divided into several power classes based on maximum radiated field strength or output power (see table 1). The power class designation is based on CEPT/ERC Recommendation 70-03 [2] and ERC Decisions.

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) – Radijska oprema v frekvenčnem območju od 9 kHz do 315 kHz za aktivne medicinske vsadke ultra majhnih moči (ULP-AMI) in pribor – 1. del: Tehnične karakteristike in preskusne metode

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
• Ref Project: ETSI EN 302 195-1 V1.1.1 (2004-01) - 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 302 195-1 V1.1.1:2006
01-marec-2006
(OHNWURPDJQHWQD]GUXåOMLYRVWLQ]DGHYHY]YH]L]UDGLMVNLPVSHNWURP(50±
5DGLMVNDRSUHPDYIUHNYHQþQHPREPRþMXRGN+]GRN+]]DDNWLYQH
PHGLFLQVNHYVDGNHXOWUDPDMKQLKPRþL8/3$0,LQSULERU±GHO7HKQLþQH
NDUDNWHULVWLNHLQSUHVNXVQHPHWRGH
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
Ta slovenski standard je istoveten z: EN 302 195-1 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 302 195-1 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 302 195-1 V1.1.1:2006

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SIST EN 302 195-1 V1.1.1:2006

ETSI EN 302 195-1 V1.1.1 (2004-03)
European Standard (Telecommunications series)

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

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SIST EN 302 195-1 V1.1.1:2006
 2 ETSI EN 302 195-1 V1.1.1 (2004-03)



Reference
DEN/ERM-TG30-001-1
Keywords
health, inductive, magnetic, mobile, radio, short
range, SRD, testing
ETSI
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Sous-Préfecture de Grasse (06) N° 7803/88

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© European Telecommunications Standards Institute 2004.
All rights reserved.

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ETSI

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SIST EN 302 195-1 V1.1.1:2006
 3 ETSI EN 302 195-1 V1.1.1 (2004-03)
Contents
Intellectual Property Rights.6
Foreword.6
1 Scope.7
2 References.8
3 Definitions, symbols and abbreviations .8
3.1 Definitions.8
3.2 Symbols.9
3.3 Abbreviations.9
4 Technical requirements specifications.10
4.1 General requirements.10
4.1.1 Receiver classification.10
4.1.2 General performance criteria .10
4.2 Presentation of equipment for testing purposes.10
4.2.1 Choice of model for testing .11
4.2.2 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) .11
4.2.2.1 Equipment with an internal permanent or temporary antenna connector.11
4.2.2.2 Equipment with a temporary antenna connector.11
4.3 Mechanical and electrical design.11
4.3.1 General.11
4.3.2 Controls.11
4.3.3 Transmitter shut-off facility.11
4.3.4 Receiver power save capability .12
4.4 Declarations by the applicant .12
4.5 Auxiliary test equipment .12
4.6 Interpretation of the measurement results .12
5 Test conditions, power sources and ambient temperatures .12
5.1 Normal and extreme test conditions .12
5.2 Test power source.12
5.2.1 External test power source.13
5.2.2 Internal test power source .13
5.3 Normal test conditions.13
5.3.1 Normal temperature and humidity.13
5.3.2 Normal test power source .13
5.3.2.1 Mains voltage.13
5.3.2.2 Regulated lead-acid battery power sources .14
5.3.2.3 Other power sources.14
5.4 Extreme test conditions .14
5.4.1 Extreme temperatures.14
5.4.1.1 Procedure for tests at extreme temperatures.14
5.4.1.1.1 Procedure for equipment designed for continuous operation .14
5.4.1.1.2 Procedure for equipment designed for intermittent operation .14
5.4.1.2 Extreme temperature ranges.15
5.4.2 Extreme test source voltages.15
5.4.2.1 Mains voltage.15
5.4.2.2 Regulated lead-acid battery power sources .15
5.4.2.3 Power sources using other types of batteries.16
5.4.2.4 Other power sources.16
6 General conditions.16
6.1 Normal test signals and test modulation.16
6.1.1 Normal test signals for data .16
6.2 Antenna.17
6.2.1 Artificial Antenna.17
ETSI

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SIST EN 302 195-1 V1.1.1:2006
 4 ETSI EN 302 195-1 V1.1.1 (2004-03)
6.3 Test fixture.17
6.3.1 Alternate test fixture for equipment intended to be implanted within a human body.17
6.4 Test sites and general arrangements for radiated measurements .18
6.5 Modes of operation of the transmitter .18
6.6 Measuring receiver.18
7 Transmitter requirements.18
7.1 Transmitter definitions.19
7.1.1 The inductive loop coil transmitters .19
7.1.2 Product classes.19
7.2 Transmitter carrier output levels .20
7.2.1 H-field (radiated).20
7.2.1.1 Definition.20
7.2.1.2 Methods of measurement.20
7.2.1.3 Limits.20
7.2.2 Radiated E-field.20
7.2.2.1 Definition.21
7.2.2.2 Methods of measurement.21
7.2.2.3 Limits.21
7.3 Permitted frequency range of the modulation bandwidth.21
7.3.1 Definition.21
7.3.2 Method of measurement.21
7.3.3 Limits.22
7.4 Spurious emissions.22
7.4.1 Definition.22
7.4.2 Radiated field strength.22
7.4.2.1 Methods of measurement (< 30 MHz) .22
7.4.2.2 Limits.23
7.5 Duty cycle.23
7.5.1 Definitions.23
7.5.2 Declaration.23
7.5.3 Duty cycle classes.23
8 Receiver requirement.24
8.1 Blocking or desensitization .24
8.1.1 Definition.24
8.1.2 Methods of measurement.24
8.1.3 Limits.25
8.2 Receiver spurious radiation .25
8.2.1 Definition.25
8.2.1.1 Methods of measurement.25
8.2.1.2 Limits.25
9 Measurement uncertainty.26
Annex A (normative): Radiated measurements .27
A.1 Test sites and general arrangements for measurements involving the use of radiated fields.27
A.1.1 Outdoor test site .27
A.1.1.1 Standard position.28
A.1.1.2 Equipment in close proximity to the human body but external to it .28
A.1.1.3 Active medical implant equipment .28
A.1.2 Test antenna.30
A.1.2.1 Below 30 MHz.30
A.1.3 Optional additional indoor site .30
A.2 Guidance on the use of radiation test sites .30
A.2.1 Measuring distance.30
A.2.2 Auxiliary cables.31
Annex B (normative): H-field limit correction factor for generated E-fields.32
Annex C (informative): E-fields in the near field at low frequencies.33
ETSI

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SIST EN 302 195-1 V1.1.1:2006
 5 ETSI EN 302 195-1 V1.1.1 (2004-03)
Annex D (normative): H-field measurements at other distances than 10 m.34
Annex E (informative): Bibliography.36
History .37

ETSI

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SIST EN 302 195-1 V1.1.1:2006
 6 ETSI EN 302 195-1 V1.1.1 (2004-03)
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 European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM).
For non-EU countries the present document may be used for regulatory (Type Approval) purposes.
The present document is part 1 of a multi-part deliverable covering Radio equipment in the frequency range 9 kHz to
315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".

National transposition dates
Date of adoption of this EN: 12 March 2004
Date of latest announcement of this EN (doa): 30 June 2004
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 December 2004
Date of withdrawal of any conflicting National Standard (dow): 31 December 2004

ETSI

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SIST EN 302 195-1 V1.1.1:2006
 7 ETSI EN 302 195-1 V1.1.1 (2004-03)
1 Scope
The present document applies to Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers
operating in the range from 9 kHz to 315 kHz and any associated radio apparatus transmitting in the frequency range of
9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital
modulation techniques such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not
within the scope of the present document.
The present document contains the technical characteristics and test methods for radio equipment and is referenced in
CEPT/ERC Recommendation 70-03 [2], annex 12 band(b).
The present document does not necessarily include all the characteristics which may be required by a user, nor does it
necessarily represent the optimum performance achievable. It is a product standard which may be completely or
partially superseded by specific standards covering specific applications.
The present document applies to ULP-AMI transceivers conforming to the following:
- inductive loop systems;
- with an antenna connection and/or with an integral antenna;
- for use as telecommunications and telecommand transmission to/from active medical implants.
ULP-AMI equipment has an inherent safety of human life implication, manufacturers and users are cautioned to pay
particular attention to the potential for interference from other systems operating in the same or adjacent bands.
The present document covers physician operated programmer/controllers transmitters (typically fixed stations), patient
operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations).
All types of digital modulation for radio devices are covered by the present document.
The radio equipment, covered by the classification SRD is divided into several power classes based on maximum
radiated field strength or output power (see table 1). The power class designation is based on CEPT/ERC
Recommendation 70-03 [2] and ERC Decisions.
Table 1: Maximum radiated H-field
Power Class Radiated H-field or power level
1 7 dBµA/m at 10 m
2 42 dBµA/m at 10 m
3 72 dBµA/m at 10 m
(at 9 kHz to 30 kHz, descending 3 dB/octave from 30 kHz to 135 kHz)
4 37,7 dBµA/m at 10 m
(at 135 kHz, descending 3 dB/octave from 135 kHz to 1 MHz)
29 dBµA/m at 10 m
(at 1,0 MHz descending 9 dB/octave from 1 MHz to 4,642 MHz)
5 9 dBµA/m at 10 m
(4,642 MHz to 30 MHz)
30 dBµA/m at 10 m
(9 kHz to 315 kHz)

ETSI

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SIST EN 302 195-1 V1.1.1:2006
 8 ETSI EN 302 195-1 V1.1.1 (2004-03)
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] 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).
[2] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[3] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[4] ETSI ETR 028: "Radio Equipment and Systems (RES); Uncertainties in the measurement of
mobile radio equipment characteristics".
[5] Air Force Technical Report AL/OE-TR-1996-0037: "Compilation of the Dielectric Properties of
Body Tissues at RF and Microwave Frequencies".
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
active medical implant: diagnostic or therapeutic device designed to be implanted in a human body containing a power
source and capable of generating radio frequency energy within the 9 kHz to 315 kHz frequency band for the purpose of
providing a digital communications link
artificial antenna: tuned reduced-radiating dummy load equal to the nominal impedance specified by the applicant
assigned frequency: frequency within the applicable band on which the device is authorized to operate
conducted measurements: measurements which are made using a direct connection to the equipment under test
custom antenna: antenna built according to manufacturers antenna design rules
dedicated antenna: removable antenna supplied and tested with the radio equipment that is designed as an
indispensable part of the equipment
fixed station: equipment intended for use in a fixed location
H-field test antenna: electrically screened loop or equivalent antenna, with which the magnetic component of the field
can be measured
integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the
equipment
magnetic dipole moment: product of (Number of coil turns) × (coil area) × (coil current)
NOTE: Air coils only.
ETSI

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SIST EN 302 195-1 V1.1.1:2006
 9 ETSI EN 302 195-1 V1.1.1 (2004-03)
medical implant device: apparatus that includes a transmitter with an integral receiver that operates in the ULP-AMI
band that is placed inside the human body for the purpose of performing diagnostic functions and/or delivery of
therapeutic treatment
medical implant programmer/control transmitter: a transmitter, operating outside of a human body in the ULP-AMI
frequency band that transfers information to/from the implant after a communications link is initiated
mobile station: equipment external to the body, normally used by a patient, to provide telecommand or telemetry
communication functions to a medical implant device placed within the body
patient activator: equipment intended to be used by a patient to communicate with an implanted device
portable station: equipment intended to be carried, attached or implanted in a human body that is operated at a
separation distance less than 20 cm from or internal to a human body
programmer/controller: ULP-AMI equipment used by a physician to communicate with an implanted device
radiated measurements: measurements which involve the absolute measurement of a radiated field
telecommand: use of radio communication for the transmission of signals to initiate, modify or terminate functions of
equipment at a distanc
...