ETSI EN 302 536 V2.1.1 (2017-10)

Final draft ETSI EN 302 536 V2.1.0 (2017-08)

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Radio equipment operating in the frequency range
315 kHz to 600 kHz for Ultra Low Power Animal
Implantable Devices (ULP-AID) and associated peripherals;
Harmonised Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU

2 Final draft ETSI EN 302 536 V2.1.0 (2017-08)

Reference
REN/ERM-TG30-309
Keywords
harmonised standard, inductive, radio, regulation

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3 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 7
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 10
3.3 Abbreviations . 10
4 Technical requirements specifications . 10
4.1 Environmental profile . 10
4.1.0 General requirements . 10
4.1.1 Conformance requirements . 11
4.2 Transmitter requirements . 11
4.2.1 Radiated Field Strength . 11
4.2.1.1 Definition . 11
4.2.1.2 Limits . 11
4.2.1.3 Conformance . 11
4.2.2 Permitted range of modulation bandwidth . 11
4.2.2.0 General . 11
4.2.2.1 Definition . 11
4.2.2.2 Limits . 11
4.2.2.3 Conformance . 11
4.2.3 Transmitter Spurious emissions . 12
4.2.3.1 Definition . 12
4.2.3.2 Limits . 12
4.2.3.3 Conformance . 12
4.2.4 Duty Cycle . 12
4.2.4.1 Definition . 12
4.2.4.2 Limits . 12
4.2.4.3 Conformance . 12
4.3 Receiver requirements . 13
4.3.1 Receiver Classification . 13
4.3.2 Receiver Blocking . 13
4.3.2.1 Definition . 13
4.3.2.2 Limits . 13
4.3.2.3 Conformance . 13
4.3.3 Receiver spurious radiations . 14
4.3.3.0 General . 14
4.3.3.1 Definition . 14
4.3.3.2 Limits . 14
4.3.3.3 Conformance . 14
5 Testing for compliance with technical requirements . 14
5.0 General requirement . 14
5.1 Normal test signals and test modulation . 14
5.1.0 General requirement . 14
5.1.1 Normal test signals for data . 14
5.2 Antenna . 15
5.2.0 General remark . 15
5.2.1 Artificial antenna . 15
ETSI
4 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
5.3 Test fixture . 15
5.3.0 General remark . 15
5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the
body of the animal . 16
5.4 Test sites and general arrangements for radiated measurements . 16
5.5 Modes of operation of the transmitter . 16
5.5.0 General remark . 16
5.5.1 Presentation of equipment for testing purposes . 16
5.5.2 Choice of model for testing . 17
5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 17
5.5.3.0 General remark . 17
5.5.3.1 Equipment with an internal permanent or temporary antenna connector . 17
5.5.3.2 Equipment with a temporary antenna connector . 17
5.5.4 Controls . 17
5.5.5 Transmitter shut-off facility . 17
5.5.6 Receiver power save capability . 17
5.5.7 Declarations by the Applicant . 18
5.5.8 Auxiliary test equipment . 18
5.6 Normal and extreme test conditions . 18
5.6.0 General remark . 18
5.6.1 Test power source . 18
5.6.2 External test power source . 18
5.6.3 Internal test power source . 18
5.7 Normal test conditions . 19
5.7.1 Normal temperature and humidity . 19
5.7.2 Normal test power source . 19
5.7.2.1 Mains voltage . 19
5.7.2.2 Regulated lead-acid battery power sources . 19
5.7.2.3 Other power sources . 19
5.8 Extreme test conditions . 20
5.8.1 Extreme temperatures . 20
5.8.1.1 Procedure for tests at extreme temperatures . 20
5.8.1.2 Procedure for equipment designed for continuous operation . 20
5.8.1.3 Procedure for equipment designed for intermittent operation . 20
5.8.1.4 Extreme temperature ranges . 21
5.8.2 Extreme test source voltages . 21
5.8.2.1 Mains voltage . 21
5.8.2.2 Regulated lead-acid battery power sources . 21
5.8.2.3 Power sources using other types of batteries . 21
5.8.2.4 Other power sources . 22
5.9 Test sites and general arrangements for radiated measurements . 22
5.10 Measuring receiver . 22
5.11 Interpretation of the measurement results . 22
5.12 Transmitter measurements. 23
5.12.0 General remark . 23
5.12.1 Transmitter design specifications . 23
5.12.1.0 Antenna requirements . 23
5.12.1.1 The inductive loop coil transmitters . 23
5.12.1.2 Antenna type . 24
5.12.2 Radiated Field Strength . 24
5.12.2.1 Radiated H-field . 24
5.12.2.1.1 General remark . 24
5.12.2.1.2 Methods of measurement. 24
5.12.3 Permitted frequency range of the modulation bandwidth . 25
5.12.3.1 General remark . 25
5.12.3.2 Method of measurement . 25
5.12.4 Transmitter Spurious emissions . 25
5.12.4.1 Radiated field strength . 25
5.12.4.1.1 Methods of measurement (< 30 MHz). 25
5.12.5 Duty cycle . 26
5.12.5.1 Declaration . 26
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5 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
5.13 Receiver Requirement . 26
5.13.1 Receiver spurious radiation. 26
5.13.1.1 General remark . 26
5.13.1.2 Methods of measurement . 26
5.14 Receiver Blocking . 26
5.14.1 Measurement procedure . 26
Annex A (informative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 28
Annex B (normative): Radiated measurements . 29
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29
B.1.1 Outdoor test site . 29
B.1.1.0 General remarks . 29
B.1.1.1 Standard position . 29
B.1.1.2 Equipment in close proximity to the animal body but external to it . 30
B.1.1.3 Active medical implant equipment (ULP-AID) . 30
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 . 32
B.2.0 General . 32
B.2.1 Measuring distance . 32
B.2.2 Auxiliary cables . 32
Annex C (normative): H-field measurements at distances other than 10 m . 33
Annex D (informative): Bibliography . 35
Annex E (informative): Change History . 36
History . 37

ETSI
6 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Intellectual Property Rights
Essential patents
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.
Trademarks
The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.
ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no
right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does
not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.
Foreword
This final draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM), and is now submitted for the Vote phase of the
ETSI standards EN Approval Procedure.
The present document has been prepared under the Commission's standardization request C (2015) 5376 final [i.4] 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.1].
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.
Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa

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.
ETSI
7 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Introduction
Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports
the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically
related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical
effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are
typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and
universities.
The present document is structured as follows:
• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document
and the definitions of terms and symbols and abbreviations used.
• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.
• Clause 5 specifies the methods of measurement for the parameters specified in clause 4.
• Annex A (informative) provides the relationship between the present document and the essential requirements
of Directive 2014/53/EU [i.1].
• Annex B (normative) provides specifications concerning radiated measurements.
• Annex C (normative) provides technical relationship between the radiating H-field and measurement distance.
• Annex D (informative) bibliography; provides additional information.

ETSI
8 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
1 Scope
The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal
Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that
provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using
inductive technology in the frequency band 315 kHz to 600 kHz.
Table 1: Ultra Low Power Animal Implants and Peripherals
Operating in the frequency band 315 kHz to 600 kHz
Ultra Low Power Animal Implants and

Peripherals service frequency bands
Transmitters - Ultra Low Power Animal
315 kHz to 600 kHz
Implants and Peripherals
Receivers - Ultra Low Power Animal
315 kHz to 600 kHz
Implants and Peripherals
The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio
equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 [i.3].
The frequency usage conditions for the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.6] with the following usage restrictions:
• "This set of usage conditions is only available to animal implantable devices".
The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the
conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant
communications system that supports development of medically related treatments that provide improved health care
for patients. 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 specific, identified by date of publication and/or edition number or version number. Only the cited
version applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
https://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 document is necessary for the application of the present document.
[1] CISPR 16-2-3 (2016): "Specification for radio disturbance and immunity measuring apparatus and
methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance
measurements".
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.
ETSI
9 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
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] 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.2] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[i.3] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.4] Commission Implementing Decision C (2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electro technical Standardisation 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.
[i.5] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.6] 2013/752/EU: "Commission Implementing Decision of 11 December 2013 amending Decision
2006/771/EC on harmonisation of the radio spectrum for use by short-range devices and repealing
Decision 2005/928/EC".
[i.7] CEPT/ERC/Recommendation 74-01E: "Unwanted Emissions in the Spurious Domain".
[i.8] Radiofrequency Radiation Dosimetry Handbook (October 1986): "USAF School of Aerospace
Medicine, Aerospace Medical Division (AFSC)", Brooks Air Force Base, TX 78235-5301.
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
animal implant device: active implant that includes a transmitter, with or without an integral receiver, that operates in
the ULP-AID band that is placed inside the body of the animal for the purpose of performing diagnostic functions
and/or delivery of therapeutic treatment
artificial antenna: tuned reduced-radiating dummy load whose impedance is equal to the nominal impedance specified
by the manufacturer
body worn device: physiologic sensor, holter type device, or other physiological data transfer device containing a
transmitter or transceiver intended to be operated in close proximity to the animal body, which has its radio antenna
external to the body, and is used to sense and/or transfer, via means of radio frequency transmission, physiological
parameters or system programming information
conducted measurements: measurements which are made using a direct connection to the equipment under test
dedicated antenna: removable antenna supplied and tested with the radio equipment that is designed as an
indispensable part of the equipment
H-field test antenna: electric field shielded loop or equivalent antenna, with which the magnetic component of the
radio frequency 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
10 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
mobile station: equipment external to the animal body intended to provide communication capability to an active
implant device placed within the body
programmer/controller: ULP-AID-P equipment used to communicate with an ultra low power animal implant device
(ULP-AID)
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
telemetry: use of radio communication for transferring data at a distance
Ultra Low Power Animal Implant Device(ULP-AID): active implant transmitter that is designed to radiate RF energy
in accordance with the provisions of Annex 12, band (c), to CEPT/ECC Recommendation 70-03 [i.3]
Ultra Low Power Animal Implant Device Peripheral (ULP-AID-P): peripheral to an active implant transmitter that
is designed to radiate RF energy in accordance with the provisions of Annex 12, band (c), to CEPT/ECC
Recommendation 70-03 [i.3]
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 B)
f frequency
H Magnetic field strength
Ho Reference magnetic field strength (see annex B)
μ magnetic dipole moment
d
P Power
R Distance
Ro Reference distance (see annex B)
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ERC European Radio Committee
EUT Equipment Under Test
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
ULP-AID Ultra Low Power - Animal Implant Device
ULP-AID-P Ultra Low Power- Animal Implant Device Peripheral
4 Technical requirements specifications
4.1 Environmental profile
4.1.0 General requirements
The technical requirements of the present document apply under the environmental profile for operation of the
equipment, which shall be declared by the manufacturer.
ETSI
11 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
4.1.1 Conformance requirements
The equipment shall comply with all the technical requirements of the present document which are identified as
applicable in annex A 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
4.2.1.1 Definition
The radiated Field is defined as the average level of the emitted H-field in the direction of maximum field strength
during the interval of continuous transmission within the operating frequency range of the EUT.
4.2.1.2 Limits
The maximum average field strength of an emission within the band 315 kHz to 600 kHz shall be -5 dBµA/m at 10 m.
Correction of a peak power measurement by a factor determined by the duration of each pulse and the period of the
pulse train at the measurement frequency is permitted to determine compliance with the limit.
4.2.1.3 Conformance
Conformance tests as defined in clause 5.12.2 shall be carried out.
4.2.2 Permitted range of modulation bandwidth
4.2.2.0 General
The permitted range of modulation bandwidth, 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 315 kHz to 600 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.
4.2.2.2 Limits
The permitted range of the modulation bandwidth shall be within the limits of the 315 kHz to 600 kHz designated
frequency band stated in annex 12 sub-band (b) of CEPT/ERC Recommendation 70-03 [i.3].
4.2.2.3 Conformance
Conformance tests as defined in clause 5.12.3 shall be carried out.
ETSI
12 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
4.2.3 Transmitter Spurious emissions
4.2.3.1 Definition
Emissions considered to be in the spurious domain for purposes of the present document are emissions at frequencies
outside the modulation bandwidth as defined in clause 4.2.2.1. The level of unwanted emissions in the spurious domain
shall be measured only for frequencies below 30 MHz.
Their effective radiated power or field strength when radiated by a transmitter with integral antenna, if applicable, is
determined 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 -25 dBuA/m
-25 dBμA/m
Standby -25 dBμA/m
-25 dBμA/m
• Limits are defined in terms of the following reference bandwidths per CEPT/ERC/Recommendation
74-01 [i.7]: 1 kHz between 9 kHz and 150 kHz;
• 10 kHz between 150 kHz and 30 MHz.
4.2.3.3 Conformance
Conformance tests as defined in clause 5.12.4 shall be carried out.
4.2.4 Duty Cycle
4.2.4.1 Definition
For the purpose of the present document the term duty cycle refers to the ratio of the total on time of transmission in any
one hour period of time under repeated normal operation during the time measurement interval. Whether the duty cycle
is fixed or random depends on how the device is triggered.
NOTE: 'Repeated normal operation' is intended to represent that operation of the EUT which results in the
maximum possible on time in the final application and may include such abnormal operations as 'stuck
keys' in mechanical systems or 'infinite loops' in programmed systems.
4.2.4.2 Limits
In a period of 1 hour the duty cycle shall not exceed 10 %.
4.2.4.3 Conformance
Conformance is based on the manufacturers declaration that the duty cycle limiting requirement of 10 % is met. See
clause 5.12.5.
ETSI
13 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
4.3 Receiver requirements
4.3.1 Receiver Classification
The product family of ULP-AID and ULP-AID-P radio devices are 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 data
collection and its impact on the animal and/or experiment results 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 ULP-AID and
ULP-AID-P performance
Highly reliable ULP-AID and ULP-AID-P communication
1 4.3.2 media; e.g. serving life inherent systems (may result in a
physical risk to a subject or loss of data)
Medium reliable ULP-AID and ULP-AID-P communication
2 4.3.2 media e.g. causing inconvenience to laboratory personnel,
which cannot simply be overcome by other means
Standard reliable ULP-AID and ULP-AID-P communication
3 4.3.2 media e.g. inconvenience to laboratory personnel, which can
simply be overcome by other means (e.g. manual)

4.3.2 Receiver Blocking
4.3.2.1 Definition
Blocking is a measure of the capability of the receiver to receive a wanted signal without exceeding a given degradation
due to the presence of an unwanted input signal at frequencies other than those of the spurious responses in adjacent
channels or bands.
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.
Table 4: Receiver blocking limits
Receiver Generator B frequency offset from band edge Limit
Classification
1 ± 2 x receiver bandwidth or 250 kHz whichever is greater Ref
± 4 x receiver bandwidth or 250 kHz whichever is greater Ref
± 8 x receiver bandwidth or 250 kHz whichever is greater Ref
± 20 x receiver bandwidth or 250 kHz whichever is greater Ref
± 2 x receiver bandwidth or 250 kHz whichever is greater Ref -15 dB
2 ± 4 x receiver bandwidth or 250 kHz whichever is greater Ref -10 dB
± 8 x receiver bandwidth or 2
...

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Radio equipment operating in the frequency range
315 kHz to 600 kHz for Ultra Low Power Animal
Implantable Devices (ULP-AID) and associated peripherals;
Harmonised Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU

2 ETSI EN 302 536 V2.1.1 (2017-10)

Reference
REN/ERM-TG30-309
Keywords
harmonised standard, inductive, radio, regulation

ETSI
650 Route des Lucioles
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Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
The present document can be downloaded from:
http://www.etsi.org/standards-search
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
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Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
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If you find errors in the present document, please send your comment to one of the following services:
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and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.

© ETSI 2017.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are trademarks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are trademarks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
oneM2M logo is protected for the benefit of its Members.
GSM® and the GSM logo are trademarks registered and owned by the GSM Association.
ETSI
3 ETSI EN 302 536 V2.1.1 (2017-10)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 7
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 10
3.3 Abbreviations . 10
4 Technical requirements specifications . 10
4.1 Environmental profile . 10
4.1.0 General requirements . 10
4.1.1 Conformance requirements . 11
4.2 Transmitter requirements . 11
4.2.1 Radiated Field Strength . 11
4.2.1.1 Definition . 11
4.2.1.2 Limits . 11
4.2.1.3 Conformance . 11
4.2.2 Permitted range of modulation bandwidth . 11
4.2.2.0 General . 11
4.2.2.1 Definition . 11
4.2.2.2 Limits . 11
4.2.2.3 Conformance . 11
4.2.3 Transmitter Spurious emissions . 12
4.2.3.1 Definition . 12
4.2.3.2 Limits . 12
4.2.3.3 Conformance . 12
4.2.4 Duty Cycle . 12
4.2.4.1 Definition . 12
4.2.4.2 Limits . 12
4.2.4.3 Conformance . 12
4.3 Receiver requirements . 13
4.3.1 Receiver Classification . 13
4.3.2 Receiver Blocking . 13
4.3.2.1 Definition . 13
4.3.2.2 Limits . 13
4.3.2.3 Conformance . 13
4.3.3 Receiver spurious radiations . 14
4.3.3.0 General . 14
4.3.3.1 Definition . 14
4.3.3.2 Limits . 14
4.3.3.3 Conformance . 14
5 Testing for compliance with technical requirements . 14
5.0 General requirement . 14
5.1 Normal test signals and test modulation . 14
5.1.0 General requirement . 14
5.1.1 Normal test signals for data . 14
5.2 Antenna . 15
5.2.0 General remark . 15
5.2.1 Artificial antenna . 15
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4 ETSI EN 302 536 V2.1.1 (2017-10)
5.3 Test fixture . 15
5.3.0 General remark . 15
5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the
body of the animal . 16
5.4 Test sites and general arrangements for radiated measurements . 16
5.5 Modes of operation of the transmitter . 16
5.5.0 General remark . 16
5.5.1 Presentation of equipment for testing purposes . 16
5.5.2 Choice of model for testing . 17
5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 17
5.5.3.0 General remark . 17
5.5.3.1 Equipment with an internal permanent or temporary antenna connector . 17
5.5.3.2 Equipment with a temporary antenna connector . 17
5.5.4 Controls . 17
5.5.5 Transmitter shut-off facility . 17
5.5.6 Receiver power save capability . 17
5.5.7 Declarations by the Applicant . 18
5.5.8 Auxiliary test equipment . 18
5.6 Normal and extreme test conditions . 18
5.6.0 General remark . 18
5.6.1 Test power source . 18
5.6.2 External test power source . 18
5.6.3 Internal test power source . 18
5.7 Normal test conditions . 19
5.7.1 Normal temperature and humidity . 19
5.7.2 Normal test power source . 19
5.7.2.1 Mains voltage . 19
5.7.2.2 Regulated lead-acid battery power sources . 19
5.7.2.3 Other power sources . 19
5.8 Extreme test conditions . 20
5.8.1 Extreme temperatures . 20
5.8.1.1 Procedure for tests at extreme temperatures . 20
5.8.1.2 Procedure for equipment designed for continuous operation . 20
5.8.1.3 Procedure for equipment designed for intermittent operation . 20
5.8.1.4 Extreme temperature ranges . 21
5.8.2 Extreme test source voltages . 21
5.8.2.1 Mains voltage . 21
5.8.2.2 Regulated lead-acid battery power sources . 21
5.8.2.3 Power sources using other types of batteries . 21
5.8.2.4 Other power sources . 22
5.9 Test sites and general arrangements for radiated measurements . 22
5.10 Measuring receiver . 22
5.11 Interpretation of the measurement results . 22
5.12 Transmitter measurements. 23
5.12.0 General remark . 23
5.12.1 Transmitter design specifications . 23
5.12.1.0 Antenna requirements . 23
5.12.1.1 The inductive loop coil transmitters . 23
5.12.1.2 Antenna type . 24
5.12.2 Radiated Field Strength . 24
5.12.2.1 Radiated H-field . 24
5.12.2.1.1 General remark . 24
5.12.2.1.2 Methods of measurement. 24
5.12.3 Permitted frequency range of the modulation bandwidth . 25
5.12.3.1 General remark . 25
5.12.3.2 Method of measurement . 25
5.12.4 Transmitter Spurious emissions . 25
5.12.4.1 Radiated field strength . 25
5.12.4.1.1 Methods of measurement (< 30 MHz). 25
5.12.5 Duty cycle . 26
5.12.5.1 Declaration . 26
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5 ETSI EN 302 536 V2.1.1 (2017-10)
5.13 Receiver Requirement . 26
5.13.1 Receiver spurious radiation. 26
5.13.1.1 General remark . 26
5.13.1.2 Methods of measurement . 26
5.14 Receiver Blocking . 26
5.14.1 Measurement procedure . 26
Annex A (informative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 28
Annex B (normative): Radiated measurements . 29
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29
B.1.1 Outdoor test site . 29
B.1.1.0 General remarks . 29
B.1.1.1 Standard position . 29
B.1.1.2 Equipment in close proximity to the animal body but external to it . 30
B.1.1.3 Active medical implant equipment (ULP-AID) . 30
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 . 32
B.2.0 General . 32
B.2.1 Measuring distance . 32
B.2.2 Auxiliary cables . 32
Annex C (normative): H-field measurements at distances other than 10 m . 33
Annex D (informative): Bibliography . 35
Annex E (informative): Change History . 36
History . 37

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6 ETSI EN 302 536 V2.1.1 (2017-10)
Intellectual Property Rights
Essential patents
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.
Trademarks
The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.
ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no
right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does
not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.
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 standardization request C (2015) 5376 final [i.4] 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.1].
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: 9 October 2017
Date of latest announcement of this EN (doa): 31 January 2018
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 July 2018
Date of withdrawal of any conflicting National Standard (dow): 31 July 2019

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.
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7 ETSI EN 302 536 V2.1.1 (2017-10)
Introduction
Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports
the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically
related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical
effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are
typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and
universities.
The present document is structured as follows:
• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document
and the definitions of terms and symbols and abbreviations used.
• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.
• Clause 5 specifies the methods of measurement for the parameters specified in clause 4.
• Annex A (informative) provides the relationship between the present document and the essential requirements
of Directive 2014/53/EU [i.1].
• Annex B (normative) provides specifications concerning radiated measurements.
• Annex C (normative) provides technical relationship between the radiating H-field and measurement distance.
• Annex D (informative) bibliography; provides additional information.

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8 ETSI EN 302 536 V2.1.1 (2017-10)
1 Scope
The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal
Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that
provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using
inductive technology in the frequency band 315 kHz to 600 kHz.
Table 1: Ultra Low Power Animal Implants and Peripherals
Operating in the frequency band 315 kHz to 600 kHz
Ultra Low Power Animal Implants and

Peripherals service frequency bands
Transmitters - Ultra Low Power Animal
315 kHz to 600 kHz
Implants and Peripherals
Receivers - Ultra Low Power Animal
315 kHz to 600 kHz
Implants and Peripherals
The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio
equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 [i.3].
The frequency usage conditions for the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.6] with the following usage restrictions:
• "This set of usage conditions is only available to animal implantable devices".
The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the
conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant
communications system that supports development of medically related treatments that provide improved health care
for patients. 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 specific, identified by date of publication and/or edition number or version number. Only the cited
version applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
https://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 document is necessary for the application of the present document.
[1] CISPR 16-2-3 (2016): "Specification for radio disturbance and immunity measuring apparatus and
methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance
measurements".
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.
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9 ETSI EN 302 536 V2.1.1 (2017-10)
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] 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.2] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[i.3] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.4] Commission Implementing Decision C (2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electro technical Standardisation 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.
[i.5] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.6] 2013/752/EU: "Commission Implementing Decision of 11 December 2013 amending Decision
2006/771/EC on harmonisation of the radio spectrum for use by short-range devices and repealing
Decision 2005/928/EC".
[i.7] CEPT/ERC/Recommendation 74-01E: "Unwanted Emissions in the Spurious Domain".
[i.8] Radiofrequency Radiation Dosimetry Handbook (October 1986): "USAF School of Aerospace
Medicine, Aerospace Medical Division (AFSC)", Brooks Air Force Base, TX 78235-5301.
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
animal implant device: active implant that includes a transmitter, with or without an integral receiver, that operates in
the ULP-AID band that is placed inside the body of the animal for the purpose of performing diagnostic functions
and/or delivery of therapeutic treatment
artificial antenna: tuned reduced-radiating dummy load whose impedance is equal to the nominal impedance specified
by the manufacturer
body worn device: physiologic sensor, holter type device, or other physiological data transfer device containing a
transmitter or transceiver intended to be operated in close proximity to the animal body, which has its radio antenna
external to the body, and is used to sense and/or transfer, via means of radio frequency transmission, physiological
parameters or system programming information
conducted measurements: measurements which are made using a direct connection to the equipment under test
dedicated antenna: removable antenna supplied and tested with the radio equipment that is designed as an
indispensable part of the equipment
H-field test antenna: electric field shielded loop or equivalent antenna, with which the magnetic component of the
radio frequency 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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10 ETSI EN 302 536 V2.1.1 (2017-10)
mobile station: equipment external to the animal body intended to provide communication capability to an active
implant device placed within the body
programmer/controller: ULP-AID-P equipment used to communicate with an ultra low power animal implant device
(ULP-AID)
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
telemetry: use of radio communication for transferring data at a distance
Ultra Low Power Animal Implant Device(ULP-AID): active implant transmitter that is designed to radiate RF energy
in accordance with the provisions of Annex 12, band (c), to CEPT/ECC Recommendation 70-03 [i.3]
Ultra Low Power Animal Implant Device Peripheral (ULP-AID-P): peripheral to an active implant transmitter that
is designed to radiate RF energy in accordance with the provisions of Annex 12, band (c), to CEPT/ECC
Recommendation 70-03 [i.3]
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 B)
f frequency
H Magnetic field strength
Ho Reference magnetic field strength (see annex B)
μ magnetic dipole moment
d
P Power
R Distance
Ro Reference distance (see annex B)
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ERC European Radio Committee
EUT Equipment Under Test
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
ULP-AID Ultra Low Power - Animal Implant Device
ULP-AID-P Ultra Low Power- Animal Implant Device Peripheral
4 Technical requirements specifications
4.1 Environmental profile
4.1.0 General requirements
The technical requirements of the present document apply under the environmental profile for operation of the
equipment, which shall be declared by the manufacturer.
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11 ETSI EN 302 536 V2.1.1 (2017-10)
4.1.1 Conformance requirements
The equipment shall comply with all the technical requirements of the present document which are identified as
applicable in annex A 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
4.2.1.1 Definition
The radiated Field is defined as the average level of the emitted H-field in the direction of maximum field strength
during the interval of continuous transmission within the operating frequency range of the EUT.
4.2.1.2 Limits
The maximum average field strength of an emission within the band 315 kHz to 600 kHz shall be -5 dBµA/m at 10 m.
Correction of a peak power measurement by a factor determined by the duration of each pulse and the period of the
pulse train at the measurement frequency is permitted to determine compliance with the limit.
4.2.1.3 Conformance
Conformance tests as defined in clause 5.12.2 shall be carried out.
4.2.2 Permitted range of modulation bandwidth
4.2.2.0 General
The permitted range of modulation bandwidth, 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 315 kHz to 600 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.
4.2.2.2 Limits
The permitted range of the modulation bandwidth shall be within the limits of the 315 kHz to 600 kHz designated
frequency band stated in annex 12 sub-band (b) of CEPT/ERC Recommendation 70-03 [i.3].
4.2.2.3 Conformance
Conformance tests as defined in clause 5.12.3 shall be carried out.
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12 ETSI EN 302 536 V2.1.1 (2017-10)
4.2.3 Transmitter Spurious emissions
4.2.3.1 Definition
Emissions considered to be in the spurious domain for purposes of the present document are emissions at frequencies
outside the modulation bandwidth as defined in clause 4.2.2.1. The level of unwanted emissions in the spurious domain
shall be measured only for frequencies below 30 MHz.
Their effective radiated power or field strength when radiated by a transmitter with integral antenna, if applicable, is
determined 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 -25 dBuA/m
-25 dBμA/m
Standby -25 dBμA/m
-25 dBμA/m
• Limits are defined in terms of the following reference bandwidths per CEPT/ERC/Recommendation
74-01 [i.7]: 1 kHz between 9 kHz and 150 kHz;
• 10 kHz between 150 kHz and 30 MHz.
4.2.3.3 Conformance
Conformance tests as defined in clause 5.12.4 shall be carried out.
4.2.4 Duty Cycle
4.2.4.1 Definition
For the purpose of the present document the term duty cycle refers to the ratio of the total on time of transmission in any
one hour period of time under repeated normal operation during the time measurement interval. Whether the duty cycle
is fixed or random depends on how the device is triggered.
NOTE: 'Repeated normal operation' is intended to represent that operation of the EUT which results in the
maximum possible on time in the final application and may include such abnormal operations as 'stuck
keys' in mechanical systems or 'infinite loops' in programmed systems.
4.2.4.2 Limits
In a period of 1 hour the duty cycle shall not exceed 10 %.
4.2.4.3 Conformance
Conformance is based on the manufacturers declaration that the duty cycle limiting requirement of 10 % is met. See
clause 5.12.5.
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13 ETSI EN 302 536 V2.1.1 (2017-10)
4.3 Receiver requirements
4.3.1 Receiver Classification
The product family of ULP-AID and ULP-AID-P radio devices are 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 data
collection and its impact on the animal and/or experiment results 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 ULP-AID and
ULP-AID-P performance
Highly reliable ULP-AID and ULP-AID-P communication
1 4.3.2 media; e.g. serving life inherent systems (may result in a
physical risk to a subject or loss of data)
Medium reliable ULP-AID and ULP-AID-P communication
2 4.3.2 media e.g. causing inconvenience to laboratory personnel,
which cannot simply be overcome by other means
Standard reliable ULP-AID and ULP-AID-P communication
3 4.3.2 media e.g. inconvenience to laboratory personnel, which can
simply be overcome by other means (e.g. manual)

4.3.2 Receiver Blocking
4.3.2.1 Definition
Blocking is a measure of the capability of the receiver to receive a wanted signal without exceeding a given degradation
due to the presence of an unwanted input signal at frequencies other than those of the spurious responses in adjacent
channels or bands.
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.
Table 4: Receiver blocking limits
Receiver Generator B frequency offset from band edge Limit
Classification
1 ± 2 x receiver bandwidth or 250 kHz whichever is greater Ref
± 4 x receiver bandwidth or 250 kHz whichever is greater Ref
± 8 x receiver bandwidth or 250 kHz whichever is greater Ref
± 20 x receiver bandwidth or 250 kHz whichever is greater Ref
± 2 x receiver bandwidth or 250 kHz whichever is greater Ref -15 dB
2 ± 4 x receiver bandwidth or 250 kHz whichever is greater Ref -10 dB
± 8 x receiver bandwidth or 250 kHz whichever is greater Ref -5 dB
± 20 x receiver bandwidth or 250 kHz whichever is greater Ref
± 2 x receiver bandwidth or 250 kHz whichever is greater Ref -18 dB
± 4 x receiver bandwidth or 250 kHz whichever is greater
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Short Range Devices (SRD) - Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals - Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:ETSI EN 302 536 V2.1.1 (2017-10)SIST EN 302 536 V2.1.1:2017en01-december-2017SIST EN 302 536 V2.1.1:2017SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 2
Reference REN/ERM-TG30-309 Keywords harmonised standard, inductive, radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are trademarks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are trademarks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. oneM2M logo is protected for the benefit of its Members. GSM® and the GSM logo are trademarks registered and owned by the GSM Association. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Modal verbs terminology . 6 Introduction . 7 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 8 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 10 3.3 Abbreviations . 10 4 Technical requirements specifications . 10 4.1 Environmental profile . 10 4.1.0 General requirements . 10 4.1.1 Conformance requirements . 11 4.2 Transmitter requirements . 11 4.2.1 Radiated Field Strength . 11 4.2.1.1 Definition . 11 4.2.1.2 Limits . 11 4.2.1.3 Conformance . 11 4.2.2 Permitted range of modulation bandwidth . 11 4.2.2.0 General . 11 4.2.2.1 Definition . 11 4.2.2.2 Limits . 11 4.2.2.3 Conformance . 11 4.2.3 Transmitter Spurious emissions . 12 4.2.3.1 Definition . 12 4.2.3.2 Limits . 12 4.2.3.3 Conformance . 12 4.2.4 Duty Cycle . 12 4.2.4.1 Definition . 12 4.2.4.2 Limits . 12 4.2.4.3 Conformance . 12 4.3 Receiver requirements . 13 4.3.1 Receiver Classification . 13 4.3.2 Receiver Blocking . 13 4.3.2.1 Definition . 13 4.3.2.2 Limits . 13 4.3.2.3 Conformance . 13 4.3.3 Receiver spurious radiations . 14 4.3.3.0 General . 14 4.3.3.1 Definition . 14 4.3.3.2 Limits . 14 4.3.3.3 Conformance . 14 5 Testing for compliance with technical requirements . 14 5.0 General requirement . 14 5.1 Normal test signals and test modulation . 14 5.1.0 General requirement . 14 5.1.1 Normal test signals for data . 14 5.2 Antenna . 15 5.2.0 General remark . 15 5.2.1 Artificial antenna . 15 SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 4 5.3 Test fixture . 15 5.3.0 General remark . 15 5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the body of the animal . 16 5.4 Test sites and general arrangements for radiated measurements . 16 5.5 Modes of operation of the transmitter . 16 5.5.0 General remark . 16 5.5.1 Presentation of equipment for testing purposes . 16 5.5.2 Choice of model for testing . 17 5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna equipment) . 17 5.5.3.0 General remark . 17 5.5.3.1 Equipment with an internal permanent or temporary antenna connector . 17 5.5.3.2 Equipment with a temporary antenna connector . 17 5.5.4 Controls . 17 5.5.5 Transmitter shut-off facility . 17 5.5.6 Receiver power save capability . 17 5.5.7 Declarations by the Applicant . 18 5.5.8 Auxiliary test equipment . 18 5.6 Normal and extreme test conditions . 18 5.6.0 General remark . 18 5.6.1 Test power source . 18 5.6.2 External test power source . 18 5.6.3 Internal test power source . 18 5.7 Normal test conditions . 19 5.7.1 Normal temperature and humidity . 19 5.7.2 Normal test power source . 19 5.7.2.1 Mains voltage . 19 5.7.2.2 Regulated lead-acid battery power sources . 19 5.7.2.3 Other power sources . 19 5.8 Extreme test conditions . 20 5.8.1 Extreme temperatures . 20 5.8.1.1 Procedure for tests at extreme temperatures . 20 5.8.1.2 Procedure for equipment designed for continuous operation . 20 5.8.1.3 Procedure for equipment designed for intermittent operation . 20 5.8.1.4 Extreme temperature ranges . 21 5.8.2 Extreme test source voltages . 21 5.8.2.1 Mains voltage . 21 5.8.2.2 Regulated lead-acid battery power sources . 21 5.8.2.3 Power sources using other types of batteries . 21 5.8.2.4 Other power sources . 22 5.9 Test sites and general arrangements for radiated measurements . 22 5.10 Measuring receiver . 22 5.11 Interpretation of the measurement results . 22 5.12 Transmitter measurements. 23 5.12.0 General remark . 23 5.12.1 Transmitter design specifications . 23 5.12.1.0 Antenna requirements . 23 5.12.1.1 The inductive loop coil transmitters . 23 5.12.1.2 Antenna type . 24 5.12.2 Radiated Field Strength . 24 5.12.2.1 Radiated H-field . 24 5.12.2.1.1 General remark . 24 5.12.2.1.2 Methods of measurement. 24 5.12.3 Permitted frequency range of the modulation bandwidth . 25 5.12.3.1 General remark . 25 5.12.3.2 Method of measurement . 25 5.12.4 Transmitter Spurious emissions . 25 5.12.4.1 Radiated field strength . 25 5.12.4.1.1 Methods of measurement (< 30 MHz). 25 5.12.5 Duty cycle . 26 5.12.5.1 Declaration . 26 SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 5 5.13 Receiver Requirement . 26 5.13.1 Receiver spurious radiation. 26 5.13.1.1 General remark . 26 5.13.1.2 Methods of measurement . 26 5.14 Receiver Blocking . 26 5.14.1 Measurement procedure . 26 Annex A (informative):
Relationship between the present document and the essential requirements of Directive 2014/53/EU . 28 Annex B (normative):
Radiated measurements . 29 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29 B.1.1 Outdoor test site . 29 B.1.1.0 General remarks . 29 B.1.1.1 Standard position . 29 B.1.1.2 Equipment in close proximity to the animal body but external to it . 30 B.1.1.3 Active medical implant equipment (ULP-AID) . 30 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 . 32 B.2.0 General . 32 B.2.1 Measuring distance . 32 B.2.2 Auxiliary cables . 32 Annex C (normative):
H-field measurements at distances other than 10 m . 33 Annex D (informative):
Bibliography . 35 Annex E (informative):
Change History . 36 History . 37
ETSI ETSI EN 302 536 V2.1.1 (2017-10) 6 Intellectual Property Rights Essential patents
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. Trademarks The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners. ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks. 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 standardization request C (2015) 5376 final [i.4] 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.1]. 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: 9 October 2017 Date of latest announcement of this EN (doa): 31 January 2018 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 July 2018 Date of withdrawal of any conflicting National Standard (dow): 31 July 2019
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. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 7 Introduction Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and universities. The present document is structured as follows: • Clauses 1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. • Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.
• Clause 5 specifies the methods of measurement for the parameters specified in clause 4. • Annex A (informative) provides the relationship between the present document and the essential requirements of Directive 2014/53/EU [i.1]. • Annex B (normative) provides specifications concerning radiated measurements. • Annex C (normative) provides technical relationship between the radiating H-field and measurement distance. • Annex D (informative) bibliography; provides additional information.
ETSI ETSI EN 302 536 V2.1.1 (2017-10) 8 1 Scope The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using inductive technology in the frequency band 315 kHz to 600 kHz. Table 1: Ultra Low Power Animal Implants and Peripherals Operating in the frequency band 315 kHz to 600 kHz
Ultra Low Power Animal Implants and Peripherals service frequency bands Transmitters - Ultra Low Power Animal Implants and Peripherals 315 kHz to 600 kHz Receivers - Ultra Low Power Animal Implants and Peripherals 315 kHz to 600 kHz
The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 [i.3]. The frequency usage conditions for the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category "active medical implant devices" according to 2013/752/EU [i.6] with the following usage restrictions: • "This set of usage conditions is only available to animal implantable devices". The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant communications system that supports development of medically related treatments that provide improved health care for patients. 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 specific, identified by date of publication and/or edition number or version number. Only the cited version applies. Referenced documents which are not found to be publicly available in the expected location might be found at https://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 document is necessary for the application of the present document. [1] CISPR 16-2-3 (2016): "Specification for radio disturbance and immunity measuring apparatus and methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements". 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. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 9 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] 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.2] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". [i.3] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)". [i.4] Commission Implementing Decision C (2015) 5376 final of 4.8.2015 on a standardisation request to the European Committee for Electro technical Standardisation 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. [i.5] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.6] 2013/752/EU: "Commission Implementing Decision of 11 December 2013 amending Decision 2006/771/EC on harmonisation of the radio spectrum for use by short-range devices and repealing Decision 2005/928/EC". [i.7] CEPT/ERC/Recommendation 74-01E: "Unwanted Emissions in the Spurious Domain". [i.8] Radiofrequency Radiation Dosimetry Handbook (October 1986): "USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC)", Brooks Air Force Base, TX 78235-5301. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: animal implant device: active implant that includes a transmitter, with or without an integral receiver, that operates in the ULP-AID band that is placed inside the body of the animal for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment artificial antenna: tuned reduced-radiating dummy load whose impedance is equal to the nominal impedance specified by the manufacturer body worn device: physiologic sensor, holter type device, or other physiological data transfer device containing a transmitter or transceiver intended to be operated in close proximity to the animal body, which has its radio antenna external to the body, and is used to sense and/or transfer, via means of radio frequency transmission, physiological parameters or system programming information conducted measurements: measurements which are made using a direct connection to the equipment under test dedicated antenna: removable antenna supplied and tested with the radio equipment that is designed as an indispensable part of the equipment H-field test antenna: electric field shielded loop or equivalent antenna, with which the magnetic component of the radio frequency 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. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 10 mobile station: equipment external to the animal body intended to provide communication capability to an active implant device placed within the body programmer/controller: ULP-AID-P equipment used to communicate with an ultra low power animal implant device (ULP-AID) 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 telemetry: use of radio communication for transferring data at a distance Ultra Low Power Animal Implant Device(ULP-AID): active implant transmitter that is designed to radiate RF energy in accordance with the provisions of Annex 12, band (c), to CEPT/ECC Recommendation 70-03 [i.3] Ultra Low Power Animal Implant Device Peripheral (ULP-AID-P): peripheral to an active implant transmitter that is designed to radiate RF energy in accordance with the provisions of Annex 12, band (c), to CEPT/ECC Recommendation 70-03 [i.3] 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 B) f frequency H Magnetic field strength Ho Reference magnetic field strength (see annex B) μd magnetic dipole moment P Power R Distance Ro Reference distance (see annex B) t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: ERC European Radio Committee EUT Equipment Under Test RF Radio Frequency RMS Root Mean Square SRD Short Range Device ULP-AID Ultra Low Power - Animal Implant Device ULP-AID-P Ultra Low Power- Animal Implant Device Peripheral 4 Technical requirements specifications 4.1 Environmental profile 4.1.0 General requirements The technical requirements of the present document apply under the environmental profile for operation of the equipment, which shall be declared by the manufacturer. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 11 4.1.1 Conformance requirements The equipment shall comply with all the technical requirements of the present document which are identified as applicable in annex A 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 4.2.1.1 Definition The radiated Field is defined as the average level of the emitted H-field in the direction of maximum field strength during the interval of continuous transmission within the operating frequency range of the EUT.
4.2.1.2 Limits The maximum average field strength of an emission within the band 315 kHz to 600 kHz shall be -5 dBµA/m at 10 m. Correction of a peak power measurement by a factor determined by the duration of each pulse and the period of the pulse train at the measurement frequency is permitted to determine compliance with the limit. 4.2.1.3 Conformance Conformance tests as defined in clause 5.12.2 shall be carried out. 4.2.2 Permitted range of modulation bandwidth 4.2.2.0 General The permitted range of modulation bandwidth, 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 315 kHz to 600 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. 4.2.2.2 Limits The permitted range of the modulation bandwidth shall be within the limits of the 315 kHz to 600 kHz designated frequency band stated in annex 12 sub-band (b) of CEPT/ERC Recommendation 70-03 [i.3]. 4.2.2.3 Conformance Conformance tests as defined in clause 5.12.3 shall be carried out. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 12 4.2.3 Transmitter Spurious emissions 4.2.3.1 Definition Emissions considered to be in the spurious domain for purposes of the present document are emissions at frequencies outside the modulation bandwidth as defined in clause 4.2.2.1. The level of unwanted emissions in the spurious domain shall be measured only for frequencies below 30 MHz. Their effective radiated power or field strength when radiated by a transmitter with integral antenna, if applicable, is determined 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 -25 dBuA/m -25 dBμA/m Standby -25 dBμA/m
-25 dBμA/m
• Limits are defined in terms of the following reference bandwidths per CEPT/ERC/Recommendation 74-01 [i.7]: 1 kHz between 9 kHz and 150 kHz; • 10 kHz between 150 kHz and 30 MHz. 4.2.3.3 Conformance Conformance tests as defined in clause 5.12.4 shall be carried out. 4.2.4 Duty Cycle 4.2.4.1 Definition For the purpose of the present document the term duty cycle refers to the ratio of the total on time of transmission in any one hour period of time under repeated normal operation during the time measurement interval. Whether the duty cycle is fixed or random depends on how the device is triggered. NOTE:
'Repeated normal operation' is intended to represent that operation of the EUT which results in the maximum possible on time in the final application and may include such abnormal operations as 'stuck keys' in mechanical systems or 'infinite loops' in programmed systems. 4.2.4.2 Limits In a period of 1 hour the duty cycle shall not exceed 10 %. 4.2.4.3 Conformance Conformance is based on the manufacturers declaration that the duty cycle limiting requirement of 10 % is met. See clause 5.12.5. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 13 4.3 Receiver requirements 4.3.1 Receiver Classification The product family of ULP-AID and ULP-AID-P radio devices are 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 data collection and its impact on the animal and/or experiment results 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 ULP-AID and
ULP-AID-P performance 1 4.3.2 Highly reliable ULP-AID and ULP-AID-P communication media; e.g. serving life inherent systems (may result in a physical risk to a subject or loss of data) 2 4.3.2 Medium reliable ULP-AID and ULP-AID-P communication media e.g. causing inconvenience to laboratory personnel, which cannot simply be overcome by other means 3 4.3.2 Standard reliable ULP-AID and ULP-AID-P communication media e.g. inconvenience to laboratory personnel, which can simply be overcome by other means (e.g. manual)
4.3.2 Receiver Blocking 4.3.2.1 Definition Blocking is a measure of the capability of the receiver to receive a wanted signal without exceeding a given degradation due to the presence of an unwanted input signal at frequencies other than those of the spurious responses in adjacent channels or bands.
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. Table 4: Receiver blocking limits Receiver Generator B frequency offset from band edge Limit Classification
1 ± 2 x receiver bandwidth or 250 kHz whichever is greater Ref ± 4 x receiver bandwidth or 250 kHz whichever is greater Ref ± 8 x receiver bandwidth or 250 kHz whichever is greater Ref ± 20 x receiver bandwidth or 250 kHz whichever is greater Ref
± 2 x receiver bandwidth or 250 kHz whichever is greater Ref -15 dB 2 ± 4 x receiver bandwidth or 250 kHz whichever is greater Ref -10 dB
± 8 x receiver bandwidth or 250 kHz whichever is greater Ref -5 dB
± 20 x receiver bandwidth or 250 kHz whichever is greater Ref 3 ± 2 x receiver bandwidth or 250 kHz whichever is greater Ref -18 dB ± 4 x receiver bandwidth or 250 kHz whichever is greater Ref -13 dB ± 8 x receiver bandwidth or 250 kHz whichever is greater Ref -8 dB ± 20 x receiver bandwidth or 250 kHz whichever is greater Ref -3 dB NOTE: Reference limit (Ref) = 30 dB at 9 kHz increasing with 10 dB/d
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