ETSI EN 302 510 V2.1.1 (2017-01)

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power Active
Medical Membrane Implants (ULP-AMI-M) and
Peripherals (ULP-AMI-M-P)
operating in the frequency range 30 MHz to 37,5 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 ETSI EN 302 510 V2.1.1 (2017-01)

Reference
REN/ERM-TG30-308
Keywords
harmonised standard, radio, regulation

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3 ETSI EN 302 510 V2.1.1 (2017-01)
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 . 11
3.3 Abbreviations . 11
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Conformance requirements . 11
4.2.1 Transmitter requirements . 11
4.2.1.1 Effective Radiated Power . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 11
4.2.1.1.3 Conformance . 12
4.2.1.2 Out of band emissions . 12
4.2.1.2.1 Definition. 12
4.2.1.2.2 Limits . 12
4.2.1.2.3 Conformance . 12
4.2.1.3 Unwanted emissions in the spurious domain of transmitters . 12
4.2.1.3.1 Definition. 12
4.2.1.3.2 Limits . 12
4.2.1.3.3 Conformance . 13
4.2.1.4 Duty Cycle . 13
4.2.1.4.1 Definition. 13
4.2.1.4.2 Limits . 13
4.2.1.4.3 Conformance . 13
4.2.2 Receiver requirements . 13
4.2.2.1 Receiver Blocking or Desensitization . 13
4.2.2.1.0 Receiver Classification . 13
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 14
4.2.2.2 Receiver Spurious radiation . 14
4.2.2.2.1 Definition. 14
4.2.2.2.2 Limits . 14
4.2.2.2.3 Conformance . 14
4.3 Mechanical and electrical design . 15
4.3.1 General . 15
4.3.2 Controls . 15
4.3.3 Transmitter shut-off facility . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General provisions . 15
5.1.1 Presentation of equipment for testing purposes . 15
5.1.1.0 General provisions . 15
5.1.1.1 Choice of model for testing . 15
5.1.1.2 Testing of equipment with alternate power levels . 16
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4 ETSI EN 302 510 V2.1.1 (2017-01)
5.1.1.3 Testing of equipment that does not have an external RF connector (integral antenna equipment) . 16
5.1.1.3.0 General Provision . 16
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.1.3.2 Equipment with a temporary antenna connector . 16
5.1.1.3.3 Equipment intended to be implanted in a human body . 16
5.1.2 Declaration by the applicant . 16
5.1.3 Auxiliary test equipment . 16
5.1.4 Test Conditions . 17
5.1.4.1 Normal and extreme test conditions . 17
5.1.4.2 Test power source . 17
5.1.4.2.0 General provisions . 17
5.1.4.2.1 External test power source . 17
5.1.4.2.2 Internal test power source . 17
5.1.4.3 Normal test conditions . 18
5.1.4.3.1 Normal temperature and humidity . 18
5.1.4.3.2 Normal test power source . 18
5.1.4.4 Extreme test conditions . 18
5.1.4.4.1 Extreme temperatures . 18
5.1.4.4.2 Extreme test source voltages . 20
5.1.4.5 Normal test signals and test modulation. 20
5.1.4.5.0 General provisions . 20
5.1.4.5.1 Normal modulation test signals for data . 20
5.1.4.6 Antennas . 21
5.1.4.6.0 General provisions . 21
5.1.4.6.1 Artificial antenna . 21
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 21
5.1.4.7 Test fixture for ULP-AMI-M-P . 21
5.1.4.8 Test fixture for ULP-AMI-M . 22
5.1.4.9 Test sites and general arrangements for radiated measurements . 22
5.1.4.10 Modes of operation of the transmitter . 22
5.1.4.11 Measuring receiver . 22
5.2 Interpretation of the measurement results . 23
5.3 Methods of measurement . 23
5.3.1 Maximum Effective Radiated Power . 23
5.3.2 Out of band emissions. 24
5.3.3 Unwanted Emissions in the spurious domain . 25
5.3.4 Duty Cycle . 26
5.3.5 Receiver Blocking or desensitization . 26
5.3.6 Receiver Spurious radiation . 26
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 28
Annex B (normative): Radiated Measurement . 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 human body but external to it . 30
B.1.1.3 Human torso simulator for ULP-AMI-M . 30
B.1.2 Test antenna . 31
B.1.3 Substitution antenna . 31
B.1.4 Optional additional indoor site . 32
B.2 Guidance on the use of radiation test sites . 33
B.2.0 General remarks . 33
B.2.1 Measuring distance . 33
B.2.2 Test antenna . 33
B.2.3 Substitution antenna . 33
B.2.4 Artificial antenna . 33
B.2.5 Auxiliary cables . 33
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5 ETSI EN 302 510 V2.1.1 (2017-01)
B.3 Further optional alternative indoor test site using an anechoic chamber . 34
B.3.0 General remarks . 34
B.3.1 Example of the construction of a shielded anechoic chamber . 34
B.3.2 Influence of parasitic reflections in anechoic chambers . 34
B.3.3 Calibration of the shielded RF anechoic chamber . 35
Annex C (normative): Technical performance of the spectrum analyser . 37
Annex D (informative): Bibliography . 38
History . 39

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6 ETSI EN 302 510 V2.1.1 (2017-01)
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.7] 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: 27 December 2016
Date of latest announcement of this EN (doa): 31 March 2017
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 September 2017
Date of withdrawal of any conflicting National Standard (dow): 30 September 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.
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7 ETSI EN 302 510 V2.1.1 (2017-01)
Introduction
Membrane Implants and associated peripheral equipment are a new technology in the medical field that provides, on a
continuing non-invasive basis after the implant is inserted, patient related real time intravenous blood pressure
information to the attending physician. This information is used for purposes of diagnosing and treating certain heart
related disorders thereby reducing significantly the hospital readmission rate.
The present document is a specific product standard applicable to Ultra Low Power Active Medical Membrane Implants
and Peripherals operating in the frequency range 30 MHz to 37,5 MHz.
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10].
The present document is structured in the following way:
• 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,
receiver, and spectrum access.
• 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. In particular clause 5.3.8 describes the monitoring
system performance specifications that have been chosen to minimize harmful interference to other equipment
or services and minimize the potential for disturbance to this equipment from ambient sources or other medical
device users in the band.
• Annex A (normative) 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 performance of the spectrum analyser.
• Annex D (informative) bibliography; provides additional information.

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8 ETSI EN 302 510 V2.1.1 (2017-01)
1 Scope
The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant
Peripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a Medical
Implant Communications System in the frequency band 30 MHz to 37,5 MHz.
Table 1: Ultra Low Power Active Medical Membrane Implants and
Peripherals operating in the frequency band 30 MHz to 37,5 MHz
Ultra Low Power Active Medical Membrane Implants

and Peripherals service frequency bands
Transmitters - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals
Receivers - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals

The present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radio
equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 [i.6].
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10] with the following usage restrictions:
• "This set of usage conditions is only available to ultra-low power medical membrane implants for blood
pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC."
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Membrane Implants
and peripherals used in a medical membrane implant communications system "… 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.1]). 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
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 documents are necessary for the application of the present document.
[1] CISPR 16-2-3 (2010): "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.
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9 ETSI EN 302 510 V2.1.1 (2017-01)
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] 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] Void.
[i.4] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices (AIMD Directive).
[i.5] Radiofrequency Radiation Dosimetry Handbook (October 1986), USAF School of Aerospace
Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301.
NOTE: See http://niremf.ifac.cnr.it/docs/HANDBOOK/home.htm.
[i.6] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.7] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electrotechnical 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.8] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by
G. Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36
(1987).
[i.10] Commission Implementing Decision 2013/752/EU 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.11] CEPT/ERC Recommendation 74-01: "Unwanted emissions in the spurious domain".
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
Active Implantable Medical Device (AIMD): any Active Medical Device (AMD) which is intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure
Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any
source of power other than that directly generated by the human body or gravity
artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant
blocking: 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 in adjacent channels or bands
NOTE: See clause 4.2.2.1.
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10 ETSI EN 302 510 V2.1.1 (2017-01)
conducted measurements: measurements which are made using a direct connection to the equipment under test
custom antenna: antenna built according to manufacturer's antenna design rules
dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part
of the equipment
duty cycle: ratio, expressed as a percentage, of the total transmitter on time to an one hour period under repeated
normal operation during the time measurement interval
NOTE 1: Whether the duty cycle is fixed or random depends on how the device is triggered.
NOTE 2: See clause 4.2.1.4.
emission bandwidth: measured as the width of the signal between the points on either side of carrier centre frequency
that are 20 dB down relative to the maximum level of the modulated carrier
integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the
equipment
out of band emissions: emissions resulting from the modulation process that are outside the emission bandwidth, but
excluding unwanted emission in the spurious domain
NOTE: See clause 4.2.1.2.
programmer/controller: equipment used by a physician to communicate with an implanted device
radiated E-field: E-field in the direction of maximum field strength under the specified conditions of measurement
NOTE: See clause 4.2.1.1.
radiated measurements: measurements which involve the absolute measurement of a radiated field
spurious radiations from receivers: emissions radiated from the antenna, the chassis and case of the receiver
NOTE: It is specified as the radiated power of a discrete signal. Included in this definition are modulation
products that are outside the 20 dB down point on either side of the fundamental emission. See
clause 4.2.2.2.
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 indicating or recording data at a distance
Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD
Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P): radio part of equipment outside the human
body that communicates with an ULP-AMI
Ultra Low Power Active Medical Implant Membrane (ULP-AMI-M): active medical implant device with resonant
transmission capability that operates in a ULP-AMI band and is placed inside the human body for the purpose of
performing diagnostic functions and/or delivery of therapeutic treatment
Ultra Low Power Active Medical Implant Membrane Peripheral(ULP-AMI-M-P): transmitter, operating outside
of a human body in a ULP-AMI frequency band that transmits energy to a membrane implant with a receiver that
receives information from a membrane implant for the purpose of determining pressure within the human body
unwanted emissions in the spurious domain: emissions on a frequency or frequencies which are outside the out of
band domain and the level of which may be reduced without affecting the corresponding transmission of information
NOTE: Emissions at frequencies other than those of the carrier and sidebands associated with normal test
modulation. See clause 4.2.1.3.
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11 ETSI EN 302 510 V2.1.1 (2017-01)
3.2 Symbols
For the purposes of the present document, the following symbols apply:
E Electrical field strength
f frequency
P Power
R Distance
t time
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AIMD Active Implantable Medical Device
AMD Active Medical Device
e.r.p. Effective Radiated Power
EMC ElectroMagnetic Compatibility
EUT Equipment Under Test
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
ULP-AMI-M Ultra Low Power Active Medical Implant Membrane
ULP-AMI-M-P Ultra Low Power Active Medical Implant Membrane Peripheral
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 manufacturer. 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 Conformance requirements
4.2.1 Transmitter requirements
4.2.1.1 Effective Radiated Power
4.2.1.1.1 Definition
The effective radiated power is the maximum power radiated during the interval of continuous transmission within the
emission bandwidth of the EUT with the highest radiated power in the direction of the maximum level under specified
conditions of measurements in the presence of modulation or without modulation as appropriate.
4.2.1.1.2 Limits
The maximum average effective radiated power of an emission within the band 30 MHz to 37,5 MHz shall not exceed
1 milliwatt e.r.p within the emission bandwidth of the EUT. If the normal operational mode of the device uses stepped
frequencies, the limit applies to the emission level of each frequency. Correction of 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.
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12 ETSI EN 302 510 V2.1.1 (2017-01)
4.2.1.1.3 Conformance
Conformance tests as defined in clause 5.3.1 shall be carried out.
4.2.1.2 Out of band emissions
4.2.1.2.1 Definition
Out of band emissions are emissions resulting from the modulation process that are outside the emission bandwidth, but
excluding unwanted emissions in the spurious domain (see clause 3.1).
4.2.1.2.2 Limits
The out of band emission shall not exceed 0,01 milliwatt e.r.p.
4.2.1.2.3 Conformance
Conformance tests as defined in clause 5.3.2 shall be carried out.
4.2.1.3 Unwanted emissions in the spurious domain of transmitters
4.2.1.3.1 Definition
Unwanted emissions in the spurious domain are emissions outside the emission bandwidth and excluding Out of band
emissions (see clause 3.1).
The spurious domain is defined at frequencies beyond the limit of 250 % of the emission bandwidth above and below
the centre frequency of the emission.
The level of any unwanted emission in the spurious domain shall be measured only for frequencies not greater than
1 000 MHz at normal conditions (see clause 5.1.4.3) as:
• 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.
4.2.1.3.2 Limits
The radiated field strength of unwanted emissions below 30 MHz shall not exceed the generated H-field at 10 m given
in table 2.
Table 2 [i.11]
State
Frequency 9 kHz ≤ f < 10 MHz Frequency 10 MHz ≤ f < 30 MHz
Operating
27 dBμA/m at 9 kHz descending 10 dB/dec -3,5 dBμA/m
Standby
5,5 dBμA/m at 9 kHz descending 10 dB/dec -25 dBμA/m

The power of any radiated unwanted emission above 30 MHz shall not exceed the values given in table 3.
Table 3 [i.11]
47 MHz to 74 MHz
87,5 MHz to 118 MHz
Other frequencies between
State 174 MHz to 230 MHz
30 MHz to 1 000 MHz
401MHz to 406MHz
470 MHz to 790 MHz
Operating 4 nW 250 nW
Standby 2 nW 2 nW
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13 ETSI EN 302 510 V2.1.1 (2017-01)
For the purpose of the present document, harmonic emissions are exempt from the limits in tables 2 and 3 but should
not exceed 0,01 milliwatt e.r.p.
The applicable reference bandwidths are listed in table 7.
4.2.1.3.3 Conformance
Conformance tests as defined in clause 5.3.3 shall be carried out.
4.2.1.4 Duty Cycle
4.2.1.4.1 Definition
For the purpose of the present document the term duty cycle refers to the ratio of the total transmitter on time to an one
hour period under repeated normal operation during the time measurement interval (see clause 3.1). Whether the duty
cycle is fixed or random depends on how the device is triggered.
4.2.1.4.2 Limits
In a period of 1 hour the duty cycle shall not exceed 10 %.
4.2.1.4.3 Conformance
Conformance is based on the manufacturers declaration that the duty cycle limit is met. See clause 5.3.4.
4.2.2 Receiver requirements
4.2.2.1 Receiver Blocking or Desensitization
4.2.2.1.0 Receiver Classification
The product family of ULP-AMI radio devices is divided into three receiver classes, see table 4, each having its own set
of minimum performance criteria. This classification is based upon the impact on persons in case the equipment does
not operate above the specified minimum performance level. Applicable equipment classification shall be specified by
the manufacturer.
Table 4
Receiver class Risk assessment of receiver performance
Highly reliable ULP-AMI communication media;
1 e.g. serving human life inherent systems
(may result in a physical risk to a person)
Medium reliable ULP-AMI communication media;
2 e.g. when a failure to operate causes inconvenience to persons, which cannot simply be
overcome by other means
Standard reliable ULP-AMI communication media;
3 e.g. when a failure to operate causes inconvenience to persons, which can simply be
overcome by other means (e.g. manual)
NOTE: In particular where an ULP-AMI-M 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.

For the purpose of the receiver performance tests, the receiver shall produce an appropriate output under normal
conditions. Where the indicated performance cannot be achieved or if it is defined differently, the manufacturer shall
declare and publish the performance criteria used to determine the performance of the receiver.
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14 ETSI EN 302 510 V2.1.1 (2017-01)
4.2.2.1.1 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 (see clause 3.1).
4.2.2.1.2 Limits
The blocking level, for any frequency within the specified ranges, shall not be less than the values given in table 5,
except at frequencies on which spurious responses are found.
Table 5
Receiver class Frequency offset (MHz) Limit
1 All offsets 30 dB
2 21 dB
±1
±2 25 dB
±5 25 dB
26 dB
±10
Class 3 receivers are exempt from this requirement.
4.2.2.1.3 Conformance
Conformance tests as defined in clause 5.3.5 shall be carried out.
4.2.2.2 Receiver Spurious radiation
4.2.2.2.1 Definition
Spurious radiations from receivers are emissions radiated from the antenna, the chassis and case of the receiver (see
clause 3.1). It is specified as the radiated power of a discrete signal. Included in this definition are modulation products
that are outside the 20 dB down point on either side of the fundamental emission.
4.2.2.2.2 Limits
The mean power in the reference bandwidth of any spurious radiation of the receiver, shall not exceed the value given
in tables 2 and 3.
The following reference bandwidths should be used:
• 1 kHz between 9 kHz and 150 kHz;
• 10 kHz between 150 kHz and 30 MHz;
• 100 kHz between 30 MHz and 1 GHz.
The limit is applicable to all receiver classes.
4.2.2.2.3 Conformance
Conformance tests as defined in clause 5.3.6 shall be carried out.
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15 ETSI EN 302 510 V2.1.1 (2017-01)
4.3 Mechanical and electrical design
4.3.1 General
The equipment shall be designed, constructed and manufactured in accordance with sound engineering practice and
with the aim of minimizing harmful interference to other equipment and services and should not receive harmful
interference from other electronic devices. Transmitters and receivers may be individual or combination units.
4.3.2 Controls
Those controls that, if maladjusted, might inc
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Short Range Devices (SRD) - Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:ETSI EN 302 510 V2.1.1 (2017-01)SIST EN 302 510 V2.1.1:2017en01-marec-2017SIST EN 302 510 V2.1.1:2017SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 2
Reference REN/ERM-TG30-308 Keywords harmonised standard, radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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© European Telecommunications Standards Institute 2017. 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 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 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 . 11 3.3 Abbreviations . 11 4 Technical requirements specifications . 11 4.1 Environmental profile . 11 4.2 Conformance requirements . 11 4.2.1 Transmitter requirements . 11 4.2.1.1 Effective Radiated Power . 11 4.2.1.1.1 Definition. 11 4.2.1.1.2 Limits . 11 4.2.1.1.3 Conformance . 12 4.2.1.2 Out of band emissions . 12 4.2.1.2.1 Definition. 12 4.2.1.2.2 Limits . 12 4.2.1.2.3 Conformance . 12 4.2.1.3 Unwanted emissions in the spurious domain of transmitters . 12 4.2.1.3.1 Definition. 12 4.2.1.3.2 Limits . 12 4.2.1.3.3 Conformance . 13 4.2.1.4 Duty Cycle . 13 4.2.1.4.1 Definition. 13 4.2.1.4.2 Limits . 13 4.2.1.4.3 Conformance . 13 4.2.2 Receiver requirements . 13 4.2.2.1 Receiver Blocking or Desensitization . 13 4.2.2.1.0 Receiver Classification . 13 4.2.2.1.1 Definition. 14 4.2.2.1.2 Limits . 14 4.2.2.1.3 Conformance . 14 4.2.2.2 Receiver Spurious radiation . 14 4.2.2.2.1 Definition. 14 4.2.2.2.2 Limits . 14 4.2.2.2.3 Conformance . 14 4.3 Mechanical and electrical design . 15 4.3.1 General . 15 4.3.2 Controls . 15 4.3.3 Transmitter shut-off facility . 15 5 Testing for compliance with technical requirements . 15 5.1 Environmental conditions for testing . 15 5.1.0 General provisions . 15 5.1.1 Presentation of equipment for testing purposes . 15 5.1.1.0 General provisions . 15 5.1.1.1 Choice of model for testing . 15 5.1.1.2 Testing of equipment with alternate power levels . 16 SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 4 5.1.1.3 Testing of equipment that does not have an external RF connector (integral antenna equipment) . 16 5.1.1.3.0 General Provision . 16 5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16 5.1.1.3.2 Equipment with a temporary antenna connector . 16 5.1.1.3.3 Equipment intended to be implanted in a human body . 16 5.1.2 Declaration by the applicant . 16 5.1.3 Auxiliary test equipment . 16 5.1.4 Test Conditions . 17 5.1.4.1 Normal and extreme test conditions . 17 5.1.4.2 Test power source . 17 5.1.4.2.0 General provisions . 17 5.1.4.2.1 External test power source . 17 5.1.4.2.2 Internal test power source . 17 5.1.4.3 Normal test conditions . 18 5.1.4.3.1 Normal temperature and humidity . 18 5.1.4.3.2 Normal test power source . 18 5.1.4.4 Extreme test conditions . 18 5.1.4.4.1 Extreme temperatures . 18 5.1.4.4.2 Extreme test source voltages . 20 5.1.4.5 Normal test signals and test modulation. 20 5.1.4.5.0 General provisions . 20 5.1.4.5.1 Normal modulation test signals for data . 20 5.1.4.6 Antennas . 21 5.1.4.6.0 General provisions . 21 5.1.4.6.1 Artificial antenna . 21 5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 21 5.1.4.7 Test fixture for ULP-AMI-M-P . 21 5.1.4.8 Test fixture for ULP-AMI-M . 22 5.1.4.9 Test sites and general arrangements for radiated measurements . 22 5.1.4.10 Modes of operation of the transmitter . 22 5.1.4.11 Measuring receiver . 22 5.2 Interpretation of the measurement results . 23 5.3 Methods of measurement . 23 5.3.1 Maximum Effective Radiated Power . 23 5.3.2 Out of band emissions. 24 5.3.3 Unwanted Emissions in the spurious domain . 25 5.3.4 Duty Cycle . 26 5.3.5 Receiver Blocking or desensitization . 26 5.3.6 Receiver Spurious radiation . 26 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 28 Annex B (normative): Radiated Measurement . 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 human body but external to it . 30 B.1.1.3 Human torso simulator for ULP-AMI-M . 30 B.1.2 Test antenna . 31 B.1.3 Substitution antenna . 31 B.1.4 Optional additional indoor site . 32 B.2 Guidance on the use of radiation test sites . 33 B.2.0 General remarks . 33 B.2.1 Measuring distance . 33 B.2.2 Test antenna . 33 B.2.3 Substitution antenna . 33 B.2.4 Artificial antenna . 33 B.2.5 Auxiliary cables . 33 SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 5 B.3 Further optional alternative indoor test site using an anechoic chamber . 34 B.3.0 General remarks . 34 B.3.1 Example of the construction of a shielded anechoic chamber . 34 B.3.2 Influence of parasitic reflections in anechoic chambers . 34 B.3.3 Calibration of the shielded RF anechoic chamber . 35 Annex C (normative): Technical performance of the spectrum analyser . 37 Annex D (informative): Bibliography . 38 History . 39
ETSI ETSI EN 302 510 V2.1.1 (2017-01) 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.7] 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: 27 December 2016 Date of latest announcement of this EN (doa): 31 March 2017 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 September 2017 Date of withdrawal of any conflicting National Standard (dow): 30 September 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. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 7 Introduction Membrane Implants and associated peripheral equipment are a new technology in the medical field that provides, on a continuing non-invasive basis after the implant is inserted, patient related real time intravenous blood pressure information to the attending physician. This information is used for purposes of diagnosing and treating certain heart related disorders thereby reducing significantly the hospital readmission rate. The present document is a specific product standard applicable to Ultra Low Power Active Medical Membrane Implants and Peripherals operating in the frequency range 30 MHz to 37,5 MHz. The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category "active medical implant devices" according to 2013/752/EU [i.10]. The present document is structured in the following way: • 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, receiver, and spectrum access. • 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. In particular clause 5.3.8 describes the monitoring system performance specifications that have been chosen to minimize harmful interference to other equipment or services and minimize the potential for disturbance to this equipment from ambient sources or other medical device users in the band. • Annex A (normative) 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 performance of the spectrum analyser. • Annex D (informative) bibliography; provides additional information.
ETSI ETSI EN 302 510 V2.1.1 (2017-01) 8 1 Scope The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant Peripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a Medical Implant Communications System in the frequency band 30 MHz to 37,5 MHz. Table 1: Ultra Low Power Active Medical Membrane Implants and Peripherals operating in the frequency band 30 MHz to 37,5 MHz
Ultra Low Power Active Medical Membrane Implants and Peripherals service frequency bands Transmitters - Ultra Low Power Active Medical Membrane Implants and peripherals 30 MHz to 37,5 MHz Receivers - Ultra Low Power Active Medical Membrane Implants and peripherals
30 MHz to 37,5 MHz
The present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radio equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 [i.6]. The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category "active medical implant devices" according to 2013/752/EU [i.10] with the following usage restrictions: • "This set of usage conditions is only available to ultra-low power medical membrane implants for blood pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC." The present document contains requirements to demonstrate that Ultra Low Power Active Medical Membrane Implants and peripherals used in a medical membrane implant communications system "… 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.1]). 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 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 documents are necessary for the application of the present document. [1] CISPR 16-2-3 (2010): "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. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 9 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] 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] Void. [i.4] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD Directive). [i.5] Radiofrequency Radiation Dosimetry Handbook (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. NOTE: See http://niremf.ifac.cnr.it/docs/HANDBOOK/home.htm. [i.6] CEPT/ERC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)". [i.7] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request to the European Committee for Electrotechnical 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.8] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by G. Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36 (1987). [i.10] Commission Implementing Decision 2013/752/EU 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.11] CEPT/ERC Recommendation 74-01: "Unwanted emissions in the spurious domain". 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Active Implantable Medical Device (AIMD): any Active Medical Device (AMD) which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant blocking: 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 in adjacent channels or bands NOTE: See clause 4.2.2.1. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 10 conducted measurements: measurements which are made using a direct connection to the equipment under test custom antenna: antenna built according to manufacturer's antenna design rules dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part of the equipment duty cycle: ratio, expressed as a percentage, of the total transmitter on time to an one hour period under repeated normal operation during the time measurement interval NOTE 1: Whether the duty cycle is fixed or random depends on how the device is triggered. NOTE 2: See clause 4.2.1.4. emission bandwidth: measured as the width of the signal between the points on either side of carrier centre frequency that are 20 dB down relative to the maximum level of the modulated carrier integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the equipment out of band emissions: emissions resulting from the modulation process that are outside the emission bandwidth, but excluding unwanted emission in the spurious domain NOTE: See clause 4.2.1.2. programmer/controller: equipment used by a physician to communicate with an implanted device radiated E-field: E-field in the direction of maximum field strength under the specified conditions of measurement NOTE: See clause 4.2.1.1. radiated measurements: measurements which involve the absolute measurement of a radiated field spurious radiations from receivers: emissions radiated from the antenna, the chassis and case of the receiver NOTE: It is specified as the radiated power of a discrete signal. Included in this definition are modulation products that are outside the 20 dB down point on either side of the fundamental emission. See clause 4.2.2.2. 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 indicating or recording data at a distance Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P): radio part of equipment outside the human body that communicates with an ULP-AMI Ultra Low Power Active Medical Implant Membrane (ULP-AMI-M): active medical implant device with resonant transmission capability that operates in a ULP-AMI band and is placed inside the human body for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment Ultra Low Power Active Medical Implant Membrane Peripheral(ULP-AMI-M-P): transmitter, operating outside of a human body in a ULP-AMI frequency band that transmits energy to a membrane implant with a receiver that receives information from a membrane implant for the purpose of determining pressure within the human body unwanted emissions in the spurious domain: emissions on a frequency or frequencies which are outside the out of band domain and the level of which may be reduced without affecting the corresponding transmission of information NOTE: Emissions at frequencies other than those of the carrier and sidebands associated with normal test modulation. See clause 4.2.1.3. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 11 3.2 Symbols For the purposes of the present document, the following symbols apply: E Electrical field strength f frequency P Power R Distance t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AIMD Active Implantable Medical Device AMD Active Medical Device e.r.p. Effective Radiated Power EMC ElectroMagnetic Compatibility EUT Equipment Under Test RF Radio Frequency RMS Root Mean Square SRD Short Range Device ULP-AMI-M Ultra Low Power Active Medical Implant Membrane ULP-AMI-M-P Ultra Low Power Active Medical Implant Membrane Peripheral 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 manufacturer. 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 Conformance requirements 4.2.1 Transmitter requirements 4.2.1.1 Effective Radiated Power 4.2.1.1.1 Definition The effective radiated power is the maximum power radiated during the interval of continuous transmission within the emission bandwidth of the EUT with the highest radiated power in the direction of the maximum level under specified conditions of measurements in the presence of modulation or without modulation as appropriate. 4.2.1.1.2 Limits The maximum average effective radiated power of an emission within the band 30 MHz to 37,5 MHz shall not exceed 1 milliwatt e.r.p within the emission bandwidth of the EUT. If the normal operational mode of the device uses stepped frequencies, the limit applies to the emission level of each frequency. Correction of 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. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 12 4.2.1.1.3 Conformance Conformance tests as defined in clause 5.3.1 shall be carried out. 4.2.1.2 Out of band emissions 4.2.1.2.1 Definition Out of band emissions are emissions resulting from the modulation process that are outside the emission bandwidth, but excluding unwanted emissions in the spurious domain (see clause 3.1). 4.2.1.2.2 Limits The out of band emission shall not exceed 0,01 milliwatt e.r.p. 4.2.1.2.3 Conformance Conformance tests as defined in clause 5.3.2 shall be carried out. 4.2.1.3 Unwanted emissions in the spurious domain of transmitters 4.2.1.3.1 Definition Unwanted emissions in the spurious domain are emissions outside the emission bandwidth and excluding Out of band emissions (see clause 3.1). The spurious domain is defined at frequencies beyond the limit of 250 % of the emission bandwidth above and below the centre frequency of the emission. The level of any unwanted emission in the spurious domain shall be measured only for frequencies not greater than 1 000 MHz at normal conditions (see clause 5.1.4.3) as: • 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. 4.2.1.3.2 Limits The radiated field strength of unwanted emissions below 30 MHz shall not exceed the generated H-field at 10 m given in table 2. Table 2 [i.11] State Frequency 9 kHz ≤ f < 10 MHz Frequency 10 MHz ≤ f < 30 MHz Operating 27 dBμA/m at 9 kHz descending 10 dB/dec -3,5 dBμA/m Standby 5,5 dBμA/m at 9 kHz descending 10 dB/dec -25 dBμA/m
The power of any radiated unwanted emission above 30 MHz shall not exceed the values given in table 3. Table 3 [i.11] State 47 MHz to 74 MHz 87,5 MHz to 118 MHz 174 MHz to 230 MHz 401MHz to 406MHz 470 MHz to 790 MHz Other frequencies between 30 MHz to 1 000 MHz Operating 4 nW 250 nW Standby 2 nW 2 nW
ETSI ETSI EN 302 510 V2.1.1 (2017-01) 13 For the purpose of the present document, harmonic emissions are exempt from the limits in tables 2 and 3 but should not exceed 0,01 milliwatt e.r.p. The applicable reference bandwidths are listed in table 7. 4.2.1.3.3 Conformance Conformance tests as defined in clause 5.3.3 shall be carried out. 4.2.1.4 Duty Cycle 4.2.1.4.1 Definition For the purpose of the present document the term duty cycle refers to the ratio of the total transmitter on time to an one hour period under repeated normal operation during the time measurement interval (see clause 3.1). Whether the duty cycle is fixed or random depends on how the device is triggered. 4.2.1.4.2 Limits In a period of 1 hour the duty cycle shall not exceed 10 %. 4.2.1.4.3 Conformance Conformance is based on the manufacturers declaration that the duty cycle limit is met. See clause 5.3.4. 4.2.2 Receiver requirements 4.2.2.1 Receiver Blocking or Desensitization 4.2.2.1.0 Receiver Classification The product family of ULP-AMI radio devices is divided into three receiver classes, see table 4, each having its own set of minimum performance criteria. This classification is based upon the impact on persons in case the equipment does not operate above the specified minimum performance level. Applicable equipment classification shall be specified by the manufacturer. Table 4 Receiver class Risk assessment of receiver performance 1 Highly reliable ULP-AMI communication media; e.g. serving human life inherent systems (may result in a physical risk to a person) 2 Medium reliable ULP-AMI communication media; e.g. when a failure to operate causes inconvenience to persons, which cannot simply be overcome by other means 3 Standard reliable ULP-AMI communication media; e.g. when a failure to operate causes inconvenience to persons, which can simply be overcome by other means (e.g. manual) NOTE: In particular where an ULP-AMI-M 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.
For the purpose of the receiver performance tests, the receiver shall produce an appropriate output under normal conditions. Where the indicated performance cannot be achieved or if it is defined differently, the manufacturer shall declare and publish the performance criteria used to determine the performance of the receiver. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 14 4.2.2.1.1 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 (see clause 3.1). 4.2.2.1.2 Limits The blocking level, for any frequency within the specified ranges, shall not be less than the values given in table 5, except at frequencies on which spurious responses are found. Table 5 Receiver class
Frequency offset (MHz) Limit 1 All offsets 30 dB 2 ±1 21 dB ±2 25 dB ±5 25 dB ±10 26 dB
Class 3 receivers are exempt from this requirement. 4.2.2.1.3 Conformance Conformance tests as defined in clause 5.3.5 shall be carried out. 4.2.2.2 Receiver Spurious radiation 4.2.2.2.1 Definition Spurious radiations from receivers are emissions radiated from the antenna, the chassis and case of the receiver (see clause 3.1). It is specified as the radiated power of a discrete signal. Included in this definition are modulation products that are outside the 20 dB down point on either side of the fundamental emission. 4.2.2.2.2 Limits The mean power in the reference bandwidth of any spurious radiation of the receiver, shall not exceed the value given in tables 2 and 3. The following reference bandwidths should be used: • 1 kHz between 9 kHz and 150 kHz; • 10 kHz between 150 kHz and 30 MHz; • 100 kHz between 30 MHz and 1 GHz. The limit is applicable to all receiver classes. 4.2.2.2.3 Conformance Conformance tests as defined in clause 5.3.6 shall be carried out. SIST EN 302 510 V2.1.1:2017

ETSI ETSI EN 302 510 V2.1.1 (2017-01) 15 4.3 Mechanical and electrical design 4.3.1 General The equipment shall be designed, constructed and manufactured in accordance with sound engineering practice and with the aim of minimizing harmful interference to other equipment and services and should not receive harmful interference from other electronic devices. Transmitters and receivers may be individual or combination units. 4.3.2 Controls Those controls that, if maladjusted, might increase the interference potentialities of the equipment shall not be easily accessible to the user. 4.3.3 Transmitter shut-o
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