ETSI EN 302 195-1 V1.1.1 (2004-01)

SLOVENSKI STANDARD
01-marec-2006
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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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
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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
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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

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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

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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)
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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.
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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 distance
telecommunications: use of radio communications for the transmission of data between various ULP-AMI devices
telemetry: use of radio communication for indicating or recording data at a distance
Ultra Low Power Active Medical Implant (ULP-AMI): active medical implant transmitter or associated medical
implant programmer/control transmitter that is designed to radiate RF energy in accordance with the provisions of
annex 12, band (b), to CEPT/ERC Recommendation 70-03 [2] and EN 302 195-1
3.2 Symbols
For the purposes of the present document, the following symbols apply:
E Electrical field strength
Eo Reference electrical field strength (see annex A)
f frequency
H Magnetic field strength
Ho Reference magnetic field strength (see annex A)
m magnetic dipole moment
P Power
R Distance
Ro Reference distance (see annex A)
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
EMC ElectroMagnetic Compatibility
RF Radio Frequency
R&TTE Radio and Telecommunications Terminal Equipment
SRD Short Range Device
ULP-AMI Ultra Low Power Active Medical Implant
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10 ETSI EN 302 195-1 V1.1.1 (2004-03)
4 Technical requirements specifications
4.1 General requirements
4.1.1 Receiver classification
The product family of ULP-AMI radio devices is divided into three Equipment Classes, see table 2, each having its own
set of minimum performance criteria. This classification is based upon the impact on persons in case the equipment
does not operate above the specified minimum performance level. Applicable equipment classification shall be
specified by the manufacturer.
Table 2
Receiver class Relevant receiver clauses Risk assessment of receiver performance
Highly reliable ULP-AMI communication media;
1 8.1 and 8.2 e.g. serving human life inherent systems (may result in a
physical risk to a person)
Medium reliable ULP-AMI communication media e.g.
2 8.1 and 8.2 causing Inconvenience to persons, which cannot simply
be overcome by other means
Standard reliable ULP-AMI communication media
3 8.2 e.g. Inconvenience to persons, which can simply be
overcome by other means (e.g. manual)
NOTE: In particular where an ULP-AMI which may have an inherent safety of human life implication,
manufacturers and users should pay particular attention to the potential for interference from other
systems operating in the same or adjacent bands.

4.1.2 General performance criteria
The receiver performance shall be in conformity with the specifications declared by the manufacturer. Where the
intended performance cannot be achieved under testing, the manufacturer shall declare and publish the performance
criteria used to determine the performance of the receiver.
4.2 Presentation of equipment for testing purposes
Each equipment submitted for testing where type approval is still in force shall fulfil the requirements of the present
document on all frequencies over which it is intended to operate.
The applicant shall declare the operating frequency, the range of operating conditions and power requirements in
consultation with the accredited laboratory, as applicable, to establish the appropriate test conditions.
Additionally, technical documentation and operating manuals, sufficient to make the test, shall be supplied.
A test fixture for equipment with an integral antenna may be supplied by the applicant (see clause 6.3). For equipment
supplied with an external antenna the applicant shall provide the antenna and a suitable test fixture as needed. In
general, compliance must be shown by performing radiated magnetic field strength measurements.
If an equipment is designed to operate with different radiated field strengths or power level, measurement of each
transmitter parameter shall be performed, according to the present document, on samples of equipment defined in
clause 4.2.1.
To simplify and harmonize the testing procedures between different testing laboratories, measurements shall be
performed, according to the present document, on samples defined in clause 4.2.1.
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11 ETSI EN 302 195-1 V1.1.1 (2004-03)
4.2.1 Choice of model for testing
The applicant shall provide one or more samples of the equipment, as appropriate for testing.
Stand alone equipment shall be offered by the applicant complete with any ancillary equipment needed for testing.
If an equipment has several optional features, considered not to affect the RF parameters then the tests need only to be
performed on the equipment configured with that combination of features considered to be the most complex, as
proposed by the applicant and agreed by the test laboratory.
In the case of integral or dedicated antenna equipment, if the equipment does not have an internal permanent 50 Ω
connector then it is permissible to supply a second sample of the equipment with a temporary antenna connector fitted
to facilitate testing, see clause 4.2.2.
4.2.2 Testing of equipment that does not have an external 50 Ω RF
connector (integral antenna equipment)
This type of equipment will normally be tested by performing radiated tests at 10 m. For devices with very low radiated
field levels, measurements may be made at closer distance and the levels extrapolated to 10 m using the procedures in
annex E.
4.2.2.1 Equipment with an internal permanent or temporary antenna connector
The means to access and/or implement the internal permanent or temporary antenna connector shall be stated by the
applicant with the aid of a diagram. The fact that use has been made of the internal antenna connection, or of a
temporary connection, to facilitate measurements shall be recorded in the test report.
4.2.2.2 Equipment with a temporary antenna connector
The applicant may submit one set of equipment with the normal antenna connected, to enable radiated measurements to
be made. The applicant shall attend the test laboratory at the conclusion of the radiated measurements, to disconnect the
antenna and fit the temporary connector if needed. The testing laboratory staff shall not connect or disconnect any
temporary antenna connector.
Alternatively, the applicant may submit two sets of equipment to the test laboratory, one fitted with a temporary antenna
connector with the antenna disconnected and another equipment with the antenna connected. Each equipment shall be
used for the appropriate tests. The applicant shall declare that the two sets of equipment are identical in all aspects
except for the antenna connector.
4.3 Mechanical and electrical design
4.3.1 General
The equipment submitted by the applicant should be designed, constructed and manufactured in accordance with sound
engineering practice and with the aim of minimizing harmful interference to other equipment and services.
Transmitters and receivers may be individual or combination units.
4.3.2 Controls
Those controls which, if maladjusted, might increase the interfering potentialities of the equipment should not be easily
accessible to the user.
4.3.3 Transmitter shut-off facility
If the transmitter is equipped with an automatic transmitter shut-off facility, it should be made inoperative for the
duration of the test.
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12 ETSI EN 302 195-1 V1.1.1 (2004-03)
4.3.4 Receiver power save capability
If the receiver is equipped with a battery-saving circuit, this circuit should be made inoperative for the duration of the
tests.
4.4 Declarations by the applicant
When submitting equipment for type testing, the applicant shall supply the necessary information required by the
appropriate application form.
The performance of the equipment submitted for type testing shall be representative of the performance of the
corresponding production model.
4.5 Auxiliary test equipment
All necessary test signal sources, test fixtures, specialized test apparatus and set-up information shall accompany the
equipment when it is submitted for type testing unless alternative arrangements are agreed to by the test house and the
manufacturer.
4.6 Interpretation of the measurement results
The interpretation of the results recorded on the appropriate test report for the measurements described in the present
document shall be as follows:
- the measured value, determined by extrapolation if needed, relating to the corresponding limit shall be used to
decide whether an equipment meets the requirements of the present document;
- the measurement uncertainty value for the measurement of each parameter shall be included in the test report;
- the recorded value of the measurement uncertainty shall, for each measurement, be equal to, or lower than, the
figures in the table of measurement uncertainty (clause 9).
5 Test conditions, power sources and ambient
temperatures
5.1 Normal and extreme test conditions
Type testing shall be made under normal test conditions, and also, where stated, under extreme test conditions. It should
be noted that emissions test on active medical implant devices may at the option of the manufacturer be performed
using the human torso simulator filled with the tissue substitute material at nominal room temperature. The purpose is to
facilitate testing at the measurement facility. Measured emission levels are not expected to vary significantly from the
levels measured at the nominal temperature of 37°C.
The test conditions and procedures shall be as specified in clauses 5.2 to 5.4.
5.2 Test power source
The equipment shall be tested using the appropriate test power source as specified in clauses 5.2.1 or 5.2.2. Where
equipment can be powered using either external or internal power sources, then the equipment shall be tested using the
external power source as specified in clause 5.2.1 then repeated using the internal power source as specified in
clause 5.2.2.
The test power source used shall be stated in the test report.
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13 ETSI EN 302 195-1 V1.1.1 (2004-03)
5.2.1 External test power source
During type tests, the power source of the equipment shall be replaced by an external test power source capable of
producing normal and extreme test voltages as specified in clauses 5.3.2 and 5.4.2. The internal impedance of the
external test power source shall be low enough for its effect on the test results to be negligible. For the purpose of the
tests, the voltage of the external test power source shall be measured at the input terminals of the equipment. The
external test power source shall be suitably de-coupled as close to the equipment battery terminals as practicable. For
radiated measurements any external power leads should be so arranged so as not to affect the measurements.
During tests the test power source voltages shall be within a tolerance of < ±1 % relative to the voltage at the beginning
of each test. The value of this tolerance can be critical for certain measurements. Using a smaller tolerance will provide
a better uncertainty value for these measurements.
5.2.2 Internal test power source
For radiated measurements on portable equipment with integral antenna, fully charged internal batteries should be used.
The batteries used should be as supplied or recommended by the applicant. If internal batteries are used, at the end of
each test the voltage shall be within a tolerance of < ±5 % relative to the voltage at the beginning of each test. For
portable devices where the batteries cannot be measured or replaced but have telemetry readout of battery voltage, it is
acceptable to record the starting and ending voltages as provided by the telemetry readout. This shall be stated in the
test report.
If appropriate, for conducted measurements or where a test fixture is used, an external power supply at the required
voltage may replace the supplied or recommended internal batteries. This shall be stated on the test report.
For equipment intended to be implanted in a human body that is hermetically sealed it may not be possible to measure
the battery voltage directly or indirectly. For this type of equipment, it is not necessary to measure the voltage at the end
of each test; however, care shall be taken to ensure that the internal battery supply voltage does not fall below the
manufacturer's specification for normal operating voltage range. For battery operated devices, it is acceptable to read
the battery voltage via telemetry readout.
5.3 Normal test conditions
5.3.1 Normal temperature and humidity
The normal temperature and humidity conditions for tests for devices external to the human body shall be any
convenient combination of temperature and humidity within the following ranges:
- temperature +15°C to +37°C;
- relative humidity 20 % to 75 %.
Active medical implant transmitters operate after implant in a human body. Accordingly, the body tends to serve as an
oven to maintain the implant temperature near 37°C. Therefore, the normal temperature and humidity conditions for
implant transmitters shall be within the following ranges:
- temperature +36°C to +38°C;
- relative humidity not applicable.
When it is impracticable to carry out tests under these conditions, a note to this effect, stating the ambient temperature
and relative humidity during the tests, shall be added to the test report.
5.3.2 Normal test power source
5.3.2.1 Mains voltage
The normal test voltage for equipment to be connected to the mains shall be the nominal mains voltage. For the purpose
of the present document, the nominal voltage shall be the declared voltage, or any of the declared voltages, for which
the equipment was designed.
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14 ETSI EN 302 195-1 V1.1.1 (2004-03)
The frequency of the test power source corresponding to the ac mains shall be between 49 Hz and 51 Hz.
5.3.2.2 Regulated lead-acid battery power sources
When the radio equipment is intended for operation with the usual types of regulated lead-acid battery power source,
the normal test voltage shall be 1,1 multiplied by the nominal voltage of the battery (e.g. 6 V, 12 V, etc.).
5.3.2.3 Other power sources
For operation from other power sources or types of battery (primary or secondary), the normal test voltage shall be that
declared by the equipment applicant and agreed by the accredited test laboratory. Such values shall be stated in the test
report.
5.4 Extreme test conditions
5.4.1 Extreme temperatures
5.4.1.1 Procedure for tests at extreme temperatures
Before measurements are made the equipment shall have reached thermal balance in the test chamber. The eq
...