SIST EN 302 195 V2.1.1:2016

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and accessories (ULP-AMI-P) operating in the
frequency range 9 kHz to 315 kHz
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 ETSI EN 302 195 V2.1.1 (2016-06)

Reference
REN/ERM-TG30-310
Keywords
health, inductive, magnetic, mobile, radio,
regulation, short range, SRD, testing

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3 ETSI EN 302 195 V2.1.1 (2016-06)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 10
3.3 Abbreviations . 10
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Transmitter requirements . 11
4.2.1 Radiated field strength . 11
4.2.1.0 General . 11
4.2.1.1 Radiated H-field . 11
4.2.1.1.0 General . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.2 Permitted range of modulation bandwidth . 12
4.2.2.0 General . 12
4.2.2.1 Definition . 12
4.2.2.2 Limits . 12
4.2.2.3 Conformance . 13
4.2.3 Spurious emissions . 13
4.2.3.0 General . 13
4.2.3.1 Definition . 13
4.2.3.2 Limits . 13
4.2.3.3 Conformance . 13
4.2.4 Duty cycle . 13
4.2.4.0 General . 13
4.2.4.1 Definitions . 13
4.2.4.2 Limits . 13
4.2.4.3 Conformance . 13
4.3 Receiver requirements . 14
4.3.1 Receiver Classification . 14
4.3.2 Blocking . 14
4.3.2.0 General . 14
4.3.2.1 Definition . 14
4.3.2.2 Limits . 14
4.3.2.3 Conformance . 15
4.3.3 Receiver spurious radiations . 15
4.3.3.0 General . 15
4.3.3.1 Definition . 15
4.3.3.2 Limits . 15
4.3.3.3 Conformance . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General remarks . 15
5.1.1 Presentation of equipment for testing purposes . 16
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4 ETSI EN 302 195 V2.1.1 (2016-06)
5.1.2 Choice of model for testing . 16
5.1.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 16
5.1.3.0 General remarks . 16
5.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.3.2 Equipment with a temporary antenna connector . 16
5.1.4 Controls . 17
5.1.5 Transmitter shut-off facility . 17
5.1.6 Receiver power save capability . 17
5.1.7 Equipment intended to be implanted in a human body . 17
5.1.8 Declarations by the Applicant . 17
5.1.9 Auxiliary test equipment . 17
5.1.10 Test conditions . 17
5.1.10.1 Normal and extreme test-conditions. 17
5.1.10.2 Test power source . 17
5.1.10.2.0 General remarks. 17
5.1.10.2.1 External test power source . 18
5.1.10.2.2 Internal test power source . 18
5.1.10.3 Normal test Condition . 18
5.1.10.3.1 Normal temperature and humidity . 18
5.1.10.3.2 Normal test power source . 18
5.1.10.4 Extreme test conditions . 19
5.1.10.4.1 Extreme temperatures . 19
5.1.10.4.2 Extreme test source voltages . 20
5.1.10.5 Normal test signals and test modulation. 21
5.1.10.5.0 General remarks. 21
5.1.10.5.1 Normal modulation test signals for data . 21
5.1.10.6 Antenna . 21
5.1.10.6.0 General remarks. 21
5.1.10.6.1 Artificial Antenna . 21
5.1.10.7 Test fixture . 22
5.1.10.7.0 General remarks. 22
5.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a human body . 22
5.1.10.8 Test sites and general arrangements for radiated measurements . 22
5.1.10.9 Modes of operation of the transmitter . 22
5.1.10.10 Measuring receiver . 23
5.2 Interpretation of the measurement results . 23
5.3 Method of Measurements . 23
5.3.1 Radiated field strength . 23
5.3.1.0 General remarks . 23
5.3.1.1 Radiated Field Strength (H-field) . 24
5.3.2 Permitted frequency range of the modulation bandwidth . 24
5.3.3 Spurious emissions . 25
5.3.4 Receiver requirement . 25
5.3.4.1 Blocking . 25
5.3.4.2 Receiver spurious radiation . 26
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 27
Annex B (normative): Radiated measurements . 28
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 28
B.1.1 Outdoor test site . 28
B.1.1.0 General remarks . 28
B.1.1.1 Standard position . 28
B.1.1.2 Equipment in close proximity to the human body but external to it . 29
B.1.1.3 Active medical implant equipment . 29
B.1.2 Test antenna . 31
B.1.2.1 Below 30 MHz . 31
B.1.3 Optional additional indoor site . 31
B.2 Guidance on the use of radiation test sites . 31
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5 ETSI EN 302 195 V2.1.1 (2016-06)
B.2.0 General remarks . 31
B.2.1 Measuring distance . 32
B.2.2 Auxiliary cables . 32
Annex C (normative): H-field measurements at other distances than 10 m . 33
Annex D (informative): Bibliography . 35
History . 36

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6 ETSI EN 302 195 V2.1.1 (2016-06)
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 (https://ipr.etsi.org/).
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 Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM).
The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.6] to
provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation
of the laws of the Member States relating to the making available on the market of radio equipment and repealing
Directive 1999/5/EC [i.2].
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive and associated
EFTA regulations.
National transposition dates
Date of adoption of this EN: 14 June 2016
Date of latest announcement of this EN (doa): 30 September 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 March 2017
Date of withdrawal of any conflicting National Standard (dow): 31 March 2018

Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and
"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of
provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
Introduction
The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-
implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate
in the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link.
The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating
attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral
antenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristics
being measured are representative of the final product placed on the market.
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7 ETSI EN 302 195 V2.1.1 (2016-06)
If equipment already placed on the market is required to be inspected it should be tested in accordance with the methods
of measurement specified in the present document.
Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the
definitions, symbols and abbreviations used.
Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter and receiver
function.
Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement results
with the maximum measurement uncertainty values.
Clause 5.3 specifies the required measurement methods.
Annex A (normative) provides the relationship between the present document and the essential requirements of
Directive 2014/53/EU [i.2].
Annex B (normative) provides specifications concerning radiated measurements.
Annex C (normative) provides procedures for H-field measurements at other distances than 10 m.
Annex D (informative) bibliography; provides additional information.

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8 ETSI EN 302 195 V2.1.1 (2016-06)
1 Scope
The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any
associated Peripherals (ULP-AMI-P) transmitters and receivers operating 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 applies to ULP-AMI/ULP/AMI-P transmitters and receivers:
• transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m;
• receivers operating in the range from 9 kHz to 315 kHz.
The present document applies to ULP-AMI devices:
• either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna;
• for telecommand, telemetry etc. applications;
• for all types of digital modulation.
The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient
programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the
implanted patient).
The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio
equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "shall be so constructed
that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference"
(article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be
required by a user, nor does it necessarily represent the optimum performance achievable.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
Not applicable.
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9 ETSI EN 302 195 V2.1.1 (2016-06)
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment and repealing Directive 1999/5/EC.
[i.3] ETSI TR 100 028 (all parts) (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters
(ERM); Uncertainties in the measurement of mobile radio equipment characteristics".
[i.4] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.5] Air Force Technical Report AL/OE-TR-1996-0037: "Compilation of the Dielectric Properties of
Body Tissues at RF and Microwave Frequencies", Camelia Gabriel.
[i.6] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardization request
to the European Committee for Electrotechnical Standardization and to the European
Telecommunications Standards Institute as regards radio equipment in support of Directive
2014/53/EU of the European Parliament and of the Council.
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 providers 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
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10 ETSI EN 302 195 V2.1.1 (2016-06)
magnetic dipole moment: product of (Number of coil turns) × (coil area) × (coil current)
NOTE: Air coils only.
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: 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 that is designed to radiate
RF energy in accordance with the provisions of annex 12, sub-band (a) and to CEPT/ERC Recommendation 70-03 [i.1]
Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P): associated medical implant
programmer/control radio part located outside the human body that communicates with an ULP-AMI in accordance
with the provisions of annex 12, sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1]
3.2 Symbols
For the purposes of the present document, the following symbols apply:
f frequency
H Magnetic field strength
Ho Reference magnetic field strength
m magnetic dipole moment
P Power
R Distance
Ro Reference distance
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
CEPT European Conference of Postal & Telecommunications Administrations
EMC ElectroMagnetic Compatibility
ERC European Research Council
EUT Equipment Under Test
FSK Frequency Shift Keying
RF Radio Frequency
SRD Short Range Device
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral
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11 ETSI EN 302 195 V2.1.1 (2016-06)
4 Technical requirements specifications
4.1 Environmental profile
The technical requirements of the present document apply under the environmental profile for operation of the
equipment, which shall be declared by the supplier. The equipment shall comply with all the technical requirements of
the present document at all times when operating within the boundary limits of the declared operational environmental
profile.
4.2 Transmitter requirements
4.2.1 Radiated field strength
4.2.1.0 General
Transmitters covered by the present document are considered to have internal and/or dedicated external antennas. In this
case, radiated field strength measurements are required. User defined antenna systems are not permitted.
4.2.1.1 Radiated H-field
4.2.1.1.0 General
The radiated H-field, as defined in clause 4.2.1.1.1, shall not exceed the limits of clause 4.2.1.1.2.
4.2.1.1.1 Definition
4.2.1.1.1.0 General
In the case of a transmitter with an integral or dedicated antenna, the H-field is measured in the direction of maximum
field strength under specified conditions of measurement.
4.2.1.1.1.1 The inductive loop coil transmitters
These transmitters are characterized by:
a) the loop coil antenna area A shall be < 30 m ;
λ
b) the length of any antenna loop element shall be < (< , where f is in MHz) or < 30 m whichever is
4 f
shorter;
c) antenna coil may have one or multiple turns.
4.2.1.1.1.2 Antenna types
This equipment is defined according to the antenna types referenced in CEPT/ERC Recommendation 70-03 [i.1].
Inductive loop coil transmitter, tested with an antenna as either:
• an integral antenna (antenna type 1); or
• a dedicated antenna supplied with the equipment (antenna type 2).
The following restrictions apply to these antenna types:
• 9 kHz to 315 kHz frequency range;
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12 ETSI EN 302 195 V2.1.1 (2016-06)
• no field customization of the antenna(s);
• loop antenna area < 30 m ; and
λ 75
• the length of any antenna loop element shall be < (< , where f is in MHz) or < 30 m whichever is
4 f
shorter.
The transmitter carrier and spurious are limited by the maximum generated H-field, (see clauses 4.2.1.1.2 and 4.2.3.2
respectively).
Where a manufacturer provides a range of standard antennas, the equipment will be tested with each antenna attached.
4.2.1.1.2 Limits
Maximum field strength under normal and extreme conditions is given in table 1.
The limits for the maximum radiated field strength within the band 9 kHz to 315 kHz are provided in table 1.
Table 1: H-field limits at 10 m
Frequency range (MHz)
H-field strength limit (H ) dBμA/m at 10 m
f
0,009 ≤ f ≤ 0,315 30
NOTE: Systems operating below 135 kHz may alternately choose to show conformance according to the
limits and technical standards specified in annex 9 of CEPT/ERC Recommendation 70-03 [i.1].

Additional information is available in CEPT/ERC Recommendation 70-03 [i.1].
4.2.1.1.3 Conformance
Conformance test as defined in clause 5.3.1.1 of the present document shall be carried out.
4.2.2 Permitted range of modulation bandwidth
4.2.2.0 General
The permitted range of operation frequencies, as defined in clause 4.2.2.1, shall not exceed the limits in clause 4.2.2.2.
4.2.2.1 Definition
The modulation bandwidth contains all associated side bands above the following level:
a) for carrier frequencies in the range of 9 kHz to 315 kHz, at the highest level of either:
- 20 dB below the carrier, or
- the appropriate spurious limit, see clause 4.2.3.2.
Where the assigned frequency band has been divided into sub-bands by the regulatory body, the above measuring levels
and bandwidths apply inside these sub-bands.
Devices whose carrier level is below the spurious limit (clause 4.2.3.2), do not have a defined modulation bandwidth.
4.2.2.2 Limits
The permitted range of the modulation bandwidth shall be within the limits of the 9 kHz to 315 kHz designated
frequency band stated in annex 12 sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].
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13 ETSI EN 302 195 V2.1.1 (2016-06)
4.2.2.3 Conformance
Conformance test as defined in clause 5.3.2 of the present document shall be carried out.
4.2.3 Spurious emissions
4.2.3.0 General
The spurious emissions, as defined in clause 4.2.3.1, shall not exceed the limits in clause 4.2.3.2.
This requirement applies to all transmitters.
4.2.3.1 Definition
Spurious emissions are emissions at frequencies other than those of the carrier and sidebands associated with normal
test modulation (clause 5.1.10.5). The level of spurious emissions shall be measured only for frequencies below
30 MHz at normal conditions (clause 5.1.10.3) as:
1) their effective radiated power or field strength when radiated by the cabinet with integral antenna, if
applicable, and any other dedicated antenna supplied by the manufacturer.
4.2.3.2 Limits
Radiated spurious emissions below 30 MHz shall not exceed the generated H-field dBμA/m at 10 m given in table 2.
Table 2
State
Frequency 9 kHz ≤ f < 10 MHz Frequency 10 MHz ≤ f < 30 MHz
Transmit
10 dBμA/m -10 dBμA/m
Standby
-5 dBμA/m -25 dBμA/m
4.2.3.3 Conformance
Conformance test as defined in clause 5.3.3 of the present document shall be carried out.
4.2.4 Duty cycle
4.2.4.0 General
The duty cycle, as defined in clause 4.2.4.1, shall be bound by the duty cycle limit in clause 4.2.4.2.
4.2.4.1 Definitions
For the purpose of the present document the term duty cycle refers to the ratio of the total on time of the "message" to
the total off time in any one hour period under repeated operation during the time measurement interval. The device
may be triggered either automatically or manually and depending on how the device is triggered will also depend on
whether the duty cycle is fixed or random.
4.2.4.2 Limits
In a period of 1 hour the duty cycle shall not exceed 10 %.
4.2.4.3 Conformance
For software controlled or pre-programmed devices, the applicant shall declare in the test report the duty cycle for the
equipment under test, not to exceed 10 %.
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14 ETSI EN 302 195 V2.1.1 (2016-06)
For manually activated or event dependant devices, with or without software controlled functions, the applicant shall
declare whether the device once triggered, follows a pre-programmed cycle, or whether the transmission is constant
until the activation mechanism is released or otherwise reset. The applicant shall also give a description of the
application for the device and include a typical usage pattern for maximizing duty cycle that would occur in a period of
1 hour. The typical usage pattern as declared by the applicant shall be used to determine the duty cycle, not to exceed
10 %.
Where an acknowledgement is required, the additional transmitter on-time shall be included and declared by the
manufacturer in the test report.
4.3 Receiver requirements
4.3.1 Receiver Classification
The product family of ULP-AMI and ULP-AMI-P radio devices is divided into three Equipment Classes, see table 3,
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 in the test report.
Table 3
Receiver class Relevant receiver clauses Risk assessment of receiver performance
Highly reliable ULP-AMI and ULP-AMI-P communication
1 4.3.2 and 4.3.3 media; e.g. serving human life inherent systems (may result
in a physical risk to a person)
Medium reliable ULP-AMI and ULP-AMI-P communication
2 4.3.2 and 4.3.3 media e.g. causing Inconvenience to persons, which cannot
simply be overcome by other means
Standard reliable ULP-AMI and ULP-AMI-P communication
3 4.3.3 media e.g. Inconvenience to persons, which can simply be
overcome by other means (e.g. manual)
NOTE: In particular where an ULP-AMI or ULP-AMI-P 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.

4.3.2 Blocking
4.3.2.0 General
The blocking, as defined in clause 4.3.2.1 shall not be less than the limits in clause 4.3.2.2.
4.3.2.1 Definition
Blocking is a measure of the capability of the receiver to receive a wanted modulated signal without exceeding a given
degradation due to the presence of an unwanted input signal at any frequencies other than those of the spurious
responses adjacent selectivity. Receivers implanted in a human body that use error detection coding and recognize a
limited command set such as pacemakers, defibrillators, etc., are not required to perform this test.
4.3.2.2 Limits
The blocking ratio, for any frequency within the specified ranges, shall not be less than the values given in table 4,
except at frequencies on which spurious responses are found. The limit value is determined by a reference limit (Ref)
plus a correction factor (dB) depending of the appropriate receiver classification.
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15 ETSI EN 302 195 V2.1.1 (2016-06)
Table 4: Receiver blocking limits
Receiver Generator B frequency offset from band edge Limit
Classification
1 2 x receiver bandwidth or 50 kHz whichever is greater Ref
2 x receiver bandwidth or 50 kHz whichever is greater Ref -15 dB
2 4 x receiver bandwidth or 50 kHz whichever is greater Ref -10 dB
8 x receiver bandwidth or 50 kHz whichever is greater Ref -5 dB
20 x receiver bandwidth or 50 kHz whichever is greater Ref
Reference limit (Ref) = 30 dB at 9 kHz increasing with 10 dB/decade to 65 dB at 30 MHz.

The receiver performance shall be in conformity with the specifications declared by the manufacturer in the test report.
4.3.2.3 Conformance
Conforma
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 302 195 V2.1.1 (2016-06)SIST EN 302 195 V2.1.1:2016en01-september-2016SIST EN 302 195 V2.1.1:2016SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 2
Reference REN/ERM-TG30-310 Keywords health, inductive, magnetic, mobile, radio, regulation, short range, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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© European Telecommunications Standards Institute 2016. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Modal verbs terminology . 6 Introduction . 6 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 10 3.3 Abbreviations . 10 4 Technical requirements specifications . 11 4.1 Environmental profile . 11 4.2 Transmitter requirements . 11 4.2.1 Radiated field strength . 11 4.2.1.0 General . 11 4.2.1.1 Radiated H-field . 11 4.2.1.1.0 General . 11 4.2.1.1.1 Definition. 11 4.2.1.1.2 Limits . 12 4.2.1.1.3 Conformance . 12 4.2.2 Permitted range of modulation bandwidth . 12 4.2.2.0 General . 12 4.2.2.1 Definition . 12 4.2.2.2 Limits . 12 4.2.2.3 Conformance . 13 4.2.3 Spurious emissions . 13 4.2.3.0 General . 13 4.2.3.1 Definition . 13 4.2.3.2 Limits . 13 4.2.3.3 Conformance . 13 4.2.4 Duty cycle . 13 4.2.4.0 General . 13 4.2.4.1 Definitions . 13 4.2.4.2 Limits . 13 4.2.4.3 Conformance . 13 4.3 Receiver requirements . 14 4.3.1 Receiver Classification . 14 4.3.2 Blocking . 14 4.3.2.0 General . 14 4.3.2.1 Definition . 14 4.3.2.2 Limits . 14 4.3.2.3 Conformance . 15 4.3.3 Receiver spurious radiations . 15 4.3.3.0 General . 15 4.3.3.1 Definition . 15 4.3.3.2 Limits . 15 4.3.3.3 Conformance . 15 5 Testing for compliance with technical requirements . 15 5.1 Environmental conditions for testing . 15 5.1.0 General remarks . 15 5.1.1 Presentation of equipment for testing purposes . 16 SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 4 5.1.2 Choice of model for testing . 16 5.1.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna equipment) . 16 5.1.3.0 General remarks . 16 5.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16 5.1.3.2 Equipment with a temporary antenna connector . 16 5.1.4 Controls . 17 5.1.5 Transmitter shut-off facility . 17 5.1.6 Receiver power save capability . 17 5.1.7 Equipment intended to be implanted in a human body . 17 5.1.8 Declarations by the Applicant . 17 5.1.9 Auxiliary test equipment . 17 5.1.10 Test conditions . 17 5.1.10.1 Normal and extreme test-conditions. 17 5.1.10.2 Test power source . 17 5.1.10.2.0 General remarks. 17 5.1.10.2.1 External test power source . 18 5.1.10.2.2 Internal test power source . 18 5.1.10.3 Normal test Condition . 18 5.1.10.3.1 Normal temperature and humidity . 18 5.1.10.3.2 Normal test power source . 18 5.1.10.4 Extreme test conditions . 19 5.1.10.4.1 Extreme temperatures . 19 5.1.10.4.2 Extreme test source voltages . 20 5.1.10.5 Normal test signals and test modulation. 21 5.1.10.5.0 General remarks. 21 5.1.10.5.1 Normal modulation test signals for data . 21 5.1.10.6 Antenna . 21 5.1.10.6.0 General remarks. 21 5.1.10.6.1 Artificial Antenna . 21 5.1.10.7 Test fixture . 22 5.1.10.7.0 General remarks. 22 5.1.10.7.1 Alternate test fixture for equipment intended to be implanted within a human body . 22 5.1.10.8 Test sites and general arrangements for radiated measurements . 22 5.1.10.9 Modes of operation of the transmitter . 22 5.1.10.10 Measuring receiver . 23 5.2 Interpretation of the measurement results . 23 5.3 Method of Measurements . 23 5.3.1 Radiated field strength . 23 5.3.1.0 General remarks . 23 5.3.1.1 Radiated Field Strength (H-field) . 24 5.3.2 Permitted frequency range of the modulation bandwidth . 24 5.3.3 Spurious emissions . 25 5.3.4 Receiver requirement . 25 5.3.4.1 Blocking . 25 5.3.4.2 Receiver spurious radiation . 26 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 27 Annex B (normative): Radiated measurements . 28 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 28 B.1.1 Outdoor test site . 28 B.1.1.0 General remarks . 28 B.1.1.1 Standard position . 28 B.1.1.2 Equipment in close proximity to the human body but external to it . 29 B.1.1.3 Active medical implant equipment . 29 B.1.2 Test antenna . 31 B.1.2.1 Below 30 MHz . 31 B.1.3 Optional additional indoor site . 31 B.2 Guidance on the use of radiation test sites . 31 SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 5 B.2.0 General remarks . 31 B.2.1 Measuring distance . 32 B.2.2 Auxiliary cables . 32 Annex C (normative): H-field measurements at other distances than 10 m . 33 Annex D (informative): Bibliography . 35 History . 36
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 6 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 (https://ipr.etsi.org/). 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 Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.6] to provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC [i.2]. Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present document, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations.
National transposition dates Date of adoption of this EN: 14 June 2016 Date of latest announcement of this EN (doa): 30 September 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2017 Date of withdrawal of any conflicting National Standard (dow): 31 March 2018
Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). "must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation. Introduction The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated non-implantable Peripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operate in the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link. The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporating attachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integral antenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristics being measured are representative of the final product placed on the market. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 7 If equipment already placed on the market is required to be inspected it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter and receiver function. Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement results with the maximum measurement uncertainty values. Clause 5.3 specifies the required measurement methods. Annex A (normative) provides the relationship between the present document and the essential requirements of Directive 2014/53/EU [i.2]. Annex B (normative) provides specifications concerning radiated measurements. Annex C (normative) provides procedures for H-field measurements at other distances than 10 m. Annex D (informative) bibliography; provides additional information.
ETSI ETSI EN 302 195 V2.1.1 (2016-06) 8 1 Scope The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any associated Peripherals (ULP-AMI-P) transmitters and receivers operating 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 applies to ULP-AMI/ULP/AMI-P transmitters and receivers: • transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m; • receivers operating in the range from 9 kHz to 315 kHz. The present document applies to ULP-AMI devices: • either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna; • for telecommand, telemetry etc. applications; • for all types of digital modulation. The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient). The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1]. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz "shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. 2 References 2.1 Normative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. Referenced documents which are not found to be publicly available in the expected location might be found at http://docbox.etsi.org/Reference. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are necessary for the application of the present document. Not applicable. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 9 2.2 Informative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. [i.1] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)". [i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC. [i.3] ETSI TR 100 028 (all parts) (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". [i.4] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.5] Air Force Technical Report AL/OE-TR-1996-0037: "Compilation of the Dielectric Properties of Body Tissues at RF and Microwave Frequencies", Camelia Gabriel. [i.6] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardization request to the European Committee for Electrotechnical Standardization and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/EU of the European Parliament and of the Council. 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 providers 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 SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 10 magnetic dipole moment: product of (Number of coil turns) × (coil area) × (coil current) NOTE: Air coils only. 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: 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 that is designed to radiate RF energy in accordance with the provisions of annex 12, sub-band (a) and to CEPT/ERC Recommendation 70-03 [i.1] Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P): associated medical implant programmer/control radio part located outside the human body that communicates with an ULP-AMI in accordance with the provisions of annex 12, sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1] 3.2 Symbols For the purposes of the present document, the following symbols apply: f frequency H Magnetic field strength Ho Reference magnetic field strength
m magnetic dipole moment P Power R Distance Ro Reference distance
t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: CEPT European Conference of Postal & Telecommunications Administrations EMC ElectroMagnetic Compatibility ERC European Research Council EUT Equipment Under Test FSK Frequency Shift Keying RF Radio Frequency SRD Short Range Device ULP-AMI Ultra Low Power Active Medical Implant ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 11 4 Technical requirements specifications 4.1 Environmental profile The technical requirements of the present document apply under the environmental profile for operation of the equipment, which shall be declared by the supplier. The equipment shall comply with all the technical requirements of the present document at all times when operating within the boundary limits of the declared operational environmental profile. 4.2 Transmitter requirements 4.2.1 Radiated field strength 4.2.1.0 General
Transmitters covered by the present document are considered to have internal and/or dedicated external antennas. In this case, radiated field strength measurements are required. User defined antenna systems are not permitted. 4.2.1.1 Radiated H-field
4.2.1.1.0 General The radiated H-field, as defined in clause 4.2.1.1.1, shall not exceed the limits of clause 4.2.1.1.2. 4.2.1.1.1 Definition 4.2.1.1.1.0 General In the case of a transmitter with an integral or dedicated antenna, the H-field is measured in the direction of maximum field strength under specified conditions of measurement.
4.2.1.1.1.1 The inductive loop coil transmitters These transmitters are characterized by: a) the loop coil antenna area A shall be < 30 m2; b) the length of any antenna loop element shall be 4λ< (< f75, where f is in MHz) or < 30 m whichever is shorter; c) antenna coil may have one or multiple turns. 4.2.1.1.1.2 Antenna types This equipment is defined according to the antenna types referenced in CEPT/ERC Recommendation 70-03 [i.1]. Inductive loop coil transmitter, tested with an antenna as either: • an integral antenna (antenna type 1); or • a dedicated antenna supplied with the equipment (antenna type 2). The following restrictions apply to these antenna types: • 9 kHz to 315 kHz frequency range; SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 12 • no field customization of the antenna(s); • loop antenna area < 30 m2; and • the length of any antenna loop element shall be <λ4 (< 75f, where f is in MHz) or < 30 m whichever is shorter. The transmitter carrier and spurious are limited by the maximum generated H-field, (see clauses 4.2.1.1.2 and 4.2.3.2 respectively). Where a manufacturer provides a range of standard antennas, the equipment will be tested with each antenna attached. 4.2.1.1.2 Limits Maximum field strength under normal and extreme conditions is given in table 1. The limits for the maximum radiated field strength within the band 9 kHz to 315 kHz are provided in table 1. Table 1: H-field limits at 10 m Frequency range (MHz) H-field strength limit (Hf) dBμA/m at 10 m 0,009 ≤ f ≤ 0,315 30 NOTE: Systems operating below 135 kHz may alternately choose to show conformance according to the limits and technical standards specified in annex 9 of CEPT/ERC Recommendation 70-03 [i.1].
Additional information is available in CEPT/ERC Recommendation 70-03 [i.1]. 4.2.1.1.3 Conformance Conformance test as defined in clause 5.3.1.1 of the present document shall be carried out. 4.2.2 Permitted range of modulation bandwidth 4.2.2.0 General The permitted range of operation frequencies, as defined in clause 4.2.2.1, shall not exceed the limits in clause 4.2.2.2. 4.2.2.1 Definition The modulation bandwidth contains all associated side bands above the following level: a) for carrier frequencies in the range of 9 kHz to 315 kHz, at the highest level of either: - 20 dB below the carrier, or - the appropriate spurious limit, see clause 4.2.3.2. Where the assigned frequency band has been divided into sub-bands by the regulatory body, the above measuring levels and bandwidths apply inside these sub-bands. Devices whose carrier level is below the spurious limit (clause 4.2.3.2), do not have a defined modulation bandwidth. 4.2.2.2 Limits The permitted range of the modulation bandwidth shall be within the limits of the 9 kHz to 315 kHz designated frequency band stated in annex 12 sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1]. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 13 4.2.2.3 Conformance Conformance test as defined in clause 5.3.2 of the present document shall be carried out. 4.2.3 Spurious emissions 4.2.3.0 General The spurious emissions, as defined in clause 4.2.3.1, shall not exceed the limits in clause 4.2.3.2. This requirement applies to all transmitters. 4.2.3.1 Definition Spurious emissions are emissions at frequencies other than those of the carrier and sidebands associated with normal test modulation (clause 5.1.10.5). The level of spurious emissions shall be measured only for frequencies below 30 MHz at normal conditions (clause 5.1.10.3) as: 1) their effective radiated power or field strength when radiated by the cabinet with integral antenna, if applicable, and any other dedicated antenna supplied by the manufacturer. 4.2.3.2 Limits Radiated spurious emissions below 30 MHz shall not exceed the generated H-field dBμA/m at 10 m given in table 2. Table 2 State Frequency 9 kHz ≤ f < 10 MHz Frequency 10 MHz ≤ f < 30 MHz Transmit 10 dBμA/m -10 dBμA/m Standby -5 dBμA/m -25 dBμA/m
4.2.3.3 Conformance Conformance test as defined in clause 5.3.3 of the present document shall be carried out. 4.2.4 Duty cycle 4.2.4.0 General The duty cycle, as defined in clause 4.2.4.1, shall be bound by the duty cycle limit in clause 4.2.4.2. 4.2.4.1 Definitions For the purpose of the present document the term duty cycle refers to the ratio of the total on time of the "message" to the total off time in any one hour period under repeated operation during the time measurement interval. The device may be triggered either automatically or manually and depending on how the device is triggered will also depend on whether the duty cycle is fixed or random. 4.2.4.2 Limits In a period of 1 hour the duty cycle shall not exceed 10 %. 4.2.4.3 Conformance For software controlled or pre-programmed devices, the applicant shall declare in the test report the duty cycle for the equipment under test, not to exceed 10 %. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 14 For manually activated or event dependant devices, with or without software controlled functions, the applicant shall declare whether the device once triggered, follows a pre-programmed cycle, or whether the transmission is constant until the activation mechanism is released or otherwise reset. The applicant shall also give a description of the application for the device and include a typical usage pattern for maximizing duty cycle that would occur in a period of 1 hour. The typical usage pattern as declared by the applicant shall be used to determine the duty cycle, not to exceed 10 %. Where an acknowledgement is required, the additional transmitter on-time shall be included and declared by the manufacturer in the test report. 4.3 Receiver requirements 4.3.1 Receiver Classification The product family of ULP-AMI and ULP-AMI-P radio devices is divided into three Equipment Classes, see table 3, 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 in the test report. Table 3 Receiver class Relevant receiver clauses Risk assessment of receiver performance
4.3.2 and 4.3.3 Highly reliable ULP-AMI and ULP-AMI-P communication media; e.g. serving human life inherent systems (may result in a physical risk to a person)
4.3.2 and 4.3.3 Medium reliable ULP-AMI and ULP-AMI-P communication media e.g. causing Inconvenience to persons, which cannot simply be overcome by other means
4.3.3 Standard reliable ULP-AMI and ULP-AMI-P communication media e.g. Inconvenience to persons, which can simply be overcome by other means (e.g. manual) NOTE: In particular where an ULP-AMI or ULP-AMI-P 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.
4.3.2 Blocking 4.3.2.0 General The blocking, as defined in clause 4.3.2.1 shall not be less than the limits in clause 4.3.2.2. 4.3.2.1 Definition Blocking is a measure of the capability of the receiver to receive a wanted modulated signal without exceeding a given degradation due to the presence of an unwanted input signal at any frequencies other than those of the spurious responses adjacent selectivity. Receivers implanted in a human body that use error detection coding and recognize a limited command set such as pacemakers, defibrillators, etc., are not required to perform this test. 4.3.2.2 Limits The blocking ratio, for any frequency within the specified ranges, shall not be less than the values given in table 4, except at frequencies on which spurious responses are found. The limit value is determined by a reference limit (Ref) plus a correction factor (dB) depending of the appropriate receiver classification. SIST EN 302 195 V2.1.1:2016

ETSI ETSI EN 302 195 V2.1.1 (2016-06) 15 Table 4: Receiver blocking limits Receiver Classification Generator B frequency offset from band edge Limit 1 2 x receiver bandwidth or 50 kHz whichever is greater Ref
2 x receiver bandwidth or 50 kHz whichever is greater Ref -15 dB 2 4 x receiver bandwidth or 50 kHz whichever is greater Ref -10 dB
8 x receiver bandwidth or 50 kHz whichever is greater Ref -5 dB
20 x receiver bandwidth or 50 kHz whichever is greater Ref Reference limit (Ref) = 30 dB at 9 kHz increasing with 10 dB/decade to 65 dB at 30 MHz.
The receiver performance shall be in conformity with the specifications declared by the manufacturer in the test report.
4.3.2.3 Conformance Conformance test as defined in clause 5.3.4.1 of the present document shall be carried out. 4.3.3 Receiver spurious radiations 4.3.3.0 General The spurious radiations below 30 MHz, as defined in clause 4.3.3.1, shall not exceed the limits in clause
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