SIST EN 301 839 V2.1.1:2016

HARMONISED EUROPEAN STANDARD
Ultra Low Power Active Medical Implants (ULP-AMI)
and associated Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 ETSI EN 301 839 V2.1.1 (2016-04)

Reference
REN/ERM-TG30-306
Keywords
radio, regulation
ETSI
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3 ETSI EN 301 839 V2.1.1 (2016-04)
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 . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Technical requirements specifications . 12
4.1 Environmental profile . 12
4.2 Conformance requirements . 12
4.2.1 Transmitter requirements . 12
4.2.1.1 Frequency error . 12
4.2.1.1.1 Definition. 12
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 13
4.2.1.2 Emission bandwidth . 13
4.2.1.2.1 Definition. 13
4.2.1.2.2 Limits . 13
4.2.1.2.3 Conformance . 13
4.2.1.3 Effective radiated power of the fundamental emission . 13
4.2.1.3.1 Definition. 13
4.2.1.3.2 Limits . 13
4.2.1.3.3 Conformance . 13
4.2.1.4 Spurious emissions of transmitter . 14
4.2.1.4.1 Definition. 14
4.2.1.4.2 Limits . 14
4.2.1.4.3 Conformance . 14
4.2.1.5 Frequency stability under low voltage conditions . 14
4.2.1.5.1 Definition. 14
4.2.1.5.2 Limits . 14
4.2.1.5.3 Conformance . 14
4.2.2 Receiver requirements . 14
4.2.2.1 Spurious radiation of receivers . 14
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 15
4.2.3 Transmitter and Receiver requirements . 15
4.2.3.1 Spectrum Access . 15
4.2.3.1.0 General requirements . 15
4.2.3.1.1 LBT/AFA spectrum access . 15
4.2.3.1.2 LP/LDC spectrum access. 15
4.2.3.2 Receiver blocking . 16
4.2.3.2.1 Definition. 16
4.2.3.2.2 Limits . 16
4.2.3.2.3 Conformance . 16
4.3 Mechanical and electrical design . 16
4.3.1 General . 16
4.3.2 Antennas . 16
4.3.3 Controls . 17
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4 ETSI EN 301 839 V2.1.1 (2016-04)
4.3.4 Transmitter shut-off facility . 17
5 Testing for compliance with technical requirements . 17
5.1 Environmental conditions for testing . 17
5.1.0 General provisions . 17
5.1.1 Presentation of equipment for testing purposes . 17
5.1.1.0 General provisions . 17
5.1.1.1 Choice of model for testing . 17
5.1.1.2 Testing of equipment with alternative power levels . 17
5.1.1.3 Presentation of equipment that does not have an external RF connector (integral antenna
equipment) . 18
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 18
5.1.1.3.2 Equipment with a temporary antenna connector . 18
5.1.1.3.3 Equipment intended to be implanted in a human body . 18
5.1.2 Declarations by the Applicant . 18
5.1.3 Auxiliary test equipment . 18
5.1.4 Test Conditions . 18
5.1.4.1 Normal and extreme test conditions . 18
5.1.4.2 Test power source . 18
5.1.4.2.0 General provisions . 18
5.1.4.2.1 External test power source . 19
5.1.4.2.2 Internal test power source . 19
5.1.4.3 Normal test conditions . 19
5.1.4.3.1 Normal temperature and humidity . 19
5.1.4.3.2 Normal test power source . 19
5.1.4.4 Extreme test conditions . 20
5.1.4.4.1 Extreme temperatures . 20
5.1.4.4.2 Extreme test source voltages . 21
5.1.4.5 Normal test signals and test modulation. 22
5.1.4.5.0 General provisions . 22
5.1.4.5.1 Normal modulation test signals for data . 22
5.1.4.6 Antennas . 22
5.1.4.6.0 General provisions . 22
5.1.4.6.1 Artificial antenna . 22
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 22
5.1.4.7 Test fixture for ULP-AMI-P . 22
5.1.4.8 Test fixture for ULP-AMI . 23
5.1.4.9 Test sites and general arrangements for radiated measurements . 23
5.1.4.10 Modes of operation of the transmitter . 23
5.1.4.11 Measuring receiver . 23
5.2 Interpretation of the measurement results . 24
5.3 Methods of measurement . 25
5.3.1 Frequency error . 25
5.3.1.0 General provisions . 25
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 25
5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 25
5.3.2 Emission bandwidth . 26
5.3.3 Effective radiated power of the fundamental emission . 26
5.3.4 Spurious emissions of transmitter . 27
5.3.5 Frequency stability under low voltage conditions . 29
5.3.6 Spurious radiation of receivers . 29
5.3.7 Spectrum Access . 30
5.3.7.1 LBT/AFA spectrum access . 30
5.3.7.1.0 General provisions . 30
5.3.7.1.1 Purpose . 30
5.3.7.1.2 General Remarks on the Measurement Configuration . 31
5.3.7.1.3 LBT threshold power level . 31
5.3.7.1.4 Monitoring system bandwidth . 32
5.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 34
5.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level,
P . 35
Th
5.3.7.1.7 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs. 36
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5 ETSI EN 301 839 V2.1.1 (2016-04)
5.3.7.1.8 Use of pre-scanned alternative channel . 36
5.3.8 Receiver blocking . 39
5.3.8.0 General remarks . 39
5.3.8.1 Measurement method using out-of-operating-region disturbance . 39
5.3.8.2 Measurement method using frequency administration commands . 40
5.3.8.3 Results based on the above test method . 40
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 41
Annex B (normative): Radiated measurements . 42
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 42
B.1.1 Outdoor test site . 42
B.1.1.0 Introduction. 42
B.1.1.1 Standard position . 42
B.1.1.2 Equipment in close proximity to the human body but external to it . 43
B.1.1.3 Human torso simulator for ULP-AMI . 43
B.1.2 Test antenna . 44
B.1.3 Substitution antenna . 44
B.1.4 Optional additional indoor site . 45
B.2 Guidance on the use of radiation test sites . 46
B.2.0 Introduction . 46
B.2.1 Measuring distance . 46
B.2.2 Test antenna . 46
B.2.3 Substitution antenna . 46
B.2.4 Artificial antenna . 46
B.2.5 Auxiliary cables . 46
B.3 Further optional alternative indoor test site using an anechoic chamber . 47
B.3.0 Introduction . 47
B.3.1 Example of the construction of a shielded anechoic chamber . 47
B.3.2 Influence of parasitic reflections in anechoic chambers . 47
B.3.3 Calibration of the shielded RF anechoic chamber . 48
Annex C (normative): Technical performance of the spectrum analyser . 50
Annex D (informative): Bibliography . 51
History . 52

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6 ETSI EN 301 839 V2.1.1 (2016-04)
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.9] to
provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation
of the laws of the Member States relating to the making available on the market of radio equipment and repealing
Directive 1999/5/EC [i.2].
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated
EFTA regulations.
National transposition dates
Date of adoption of this EN: 25 April 2016
Date of latest announcement of this EN (doa): 31 July 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 January 2017
Date of withdrawal of any conflicting National Standard (dow): 31 January 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 301 839 V2.1.1 (2016-04)
Introduction
ULP-AMI/ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical
field, that provides high speed communications capability between individuals with AIMDs and medical practitioners
engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to individuals with various
illnesses. Equipment in the MICS service consists of active medical implants that communicate to other active medical
implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters.
The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with
an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing,
providing the characteristics being measured are not expected to be affected.
If equipment, which is available on the market, is required to be checked it should be tested in accordance with the
methods of measurement specified in the present document.
Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the
definitions, symbols and abbreviations used.
Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter, 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 5.3.7 specifies the required measurement methods. In particular clause 5.3.7.1 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.2].
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 301 839 V2.1.1 (2016-04)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI).
• Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands in table 1.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Transmit Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
Receive Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)

The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is
also addressed by ERC/DEC (01)17 [i.1].
It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz:
• for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or
• for telecommand and telemetry to/from an AIMD to another AIMD within the human body.
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS) "… shall be so
constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful
interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which
may be required by a user, nor does it necessarily represent the optimum performance achievable.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
[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".
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9 ETSI EN 301 839 V2.1.1 (2016-04)
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] ECC Decision (01)17 (2011 amendment): "Harmonised frequencies, technical characteristics and
exemption from individual licensing of Ultra Low Power Active Medical Implant (ULP-AMI)
communication systems operating in the frequency band 401 - 406 MHz on a secondary basis".
[i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment and repealing Directive 1999/5/EC (RE-D).
[i.3] ETSI TR 100 028 (all parts) (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters
(ERM); Uncertainties in the measurement of mobile radio equipment characteristics".
[i.4] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.5] 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/REC 74-01: "Unwanted Emissions in the Spurious Domain".
[i.7] Recommendation ITU-R RS.1346: "Sharing between the meteorological aids service and medical
implant communication systems (MICS) operating in the mobile service in the frequency band
401-406 MHz".
[i.8] "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.9] 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.
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
access protocol: specification for measuring natural and man-made ambient background levels for the purpose of
providing a technique for spectrum access that reduces the potential for harmful interference to/from other users of the
spectrum
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
Adaptive Frequency Agility (AFA): ability to determine and use an unoccupied sub-band or channel of operation in
order to maximize spectrum utilization
artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant
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10 ETSI EN 301 839 V2.1.1 (2016-04)
conducted measurements: measurements that are made using a direct connection to the equipment under test
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 maximum transmitter "on" time monitored over one hour, relative to
a one hour period
NOTE: See clause 4.2.3.1.2.2.
effective radiated power: power radiated within the emission bandwidth of the EUT in the direction of the maximum
level under specified conditions of measurements in the presence of modulation or without modulation as appropriate
NOTE: See clause 4.2.1.3.1.
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
NOTE: See clause 5.3.2 for details on how to determine compliance.
frequency error: difference between the nominal frequency as measured on the devices under test and under normal
test conditions and the frequency under extreme conditions
NOTE: See also clause 4.2.1.1.1.
frequency stability under low voltage condition: ability of the equipment to remain on the nominal operating
frequency when the battery voltage falls below the lower extreme voltage level
NOTE: See also clause 4.2.1.5.1.
integral antenna: permanent fixed antenna, which may be built-in, designed as an indispensable part of the equipment
LBT threshold power level: ambient signal power level above which the monitoring system selects spectrum for use in
a MICS communication session according to the next available channel with the lowest level of ambient signal power
or least interfered channel (LIC)
Least Interfered Channel (LIC): channel, among the available channels that has the lowest potential for causing
disturbance to or receiving disturbance from other users of the band
NOTE: LIC may be used for spectrum selection provided the monitoring system has sufficient sensitivity to
measure ambient signals at or below the LBT threshold power level. See clause 5.3.7.1.6.
Listen Before Talk (LBT): combination of the listen mode followed by the talk mode
listen mode: action taken by an interrogator to detect an unoccupied sub-band or channel
Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be
used for human beings in the:
• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic
means, but which may be assisted in its function by such means
medical implant communication channel: Any continuous segment of spectrum that is equal to the emission
bandwidth of the device with the largest bandwidth that is to participate in a MICL session. Aggregation of spectrum up
to a maximum of 300 kHz for a single system is permitted.
NOTE 1: As stated in ECC Decision (01)17 [i.1], it is permitted to combine adjacent channels for increased
bandwidth up to 300 kHz.
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11 ETSI EN 301 839 V2.1.1 (2016-04)
NOTE 2: Two types of devices for Medical Implant Communications Systems are covered by the present
document:
(i) Frequency agile devices designed to access a minimum of nine channels evenly distributed across
the 402 MHz to 405 MHz band.
(ii) Single frequency devices restricted to the 403,5 MHz to 403,8 MHz centre channel.
Medical Implant Communication Link (MICL): collection of transmissions that may or may not be continuous,
between ULP-AMIs and ULP-AMI-Ps, including programmer/controllers, transferring patient related information in a
communications service
Medical Implant Communications System (MICS): system specifically for the purpose of providing non-voice
digital communications between one or several ULP-AMI and one ULP-AMI-P or between ULP-AMI
Medical Implant Communications System (MICS) session: collection of transmissions that may or may not be
continuous, between co-operating ULP-AMI and ULP-AMI-P
medical implant event: occurrence or the lack of an occurrence recognized by a medical implant device or duly
authorized health care professional that requires the immediate transmission of data from a medical implant transmitter
in order to protect the safety of the person in whom the medical implant transmitter has been placed
NOTE: It is not permitted that this is the only mechanism a medical implant transmitter can use to access
spectrum.
monitoring system: circuitry in an ULP-AMI and/or ULP-AMI-P that assures conformity with the spectrum access
protocol requirements based on Listen before Talk, Adaptive Frequency Agility and selection of the least interfered
channel for operation (LIC)
radiated measurements: measurements, which involve the absolute measurement of a radiated field
spurious domain radiations from the receiver: components at any frequency, generated and radiated by active
receiver circuitry and the antenna
NOTE: See clause 4.2.2.1.1.
talk mode: transmission of intentional radiation by a transmitter
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
time-critical data: data which if not transferred immediately will result in compromising the health and/or safety of the
patient
Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD
Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: the radio part of equipment outside the
human body that communicates with an ULP-AMI to establish a MICL
unwanted emissions: emissions in the spurious domain and out of band domain
NOTE: See clause 4.2.1.4.1.
3.2 Symbols
For the purposes of the present document, the following symbols apply:
B bandwidth
dB decibel
E electrical field strength
Eo reference electrical field strength (see annex B)
f frequency
f channel centre frequency
c
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12 ETSI EN 301 839 V2.1.1 (2016-04)
f frequency under extreme conditions
e
G Antenna Gain
NaCl sodium chloride
P power
R distance
Ro Reference distance (see annex B)
P maximum threshold power level (see clause 4.2.3.1.1.2)
Th
t time
λ wavelength
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AFA Adaptive Frequency Agility
AIMD Active Implantable Medical Device
CW Continuous Wave
e.r.p. effective radiated power
EUT Equipment Under Test
LBT Listen Before Talk
LDC Low Duty Cycle
LIC Least Interfered Channel
LP Low Power
MD Medical Device
MICL Medical Implant Communication Link
MICS Medical Implant Communications System
RF Radio Frequency
r.m.s. root mean square
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral
VSWR Voltage Standing Wave Ratio
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 Frequency error
4.2.1.1.1 Definition
The frequency error, also known as frequency drift, is the difference between the nominal frequency as measured on the
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU33.060.20Sprejemna 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 301 839 V2.1.1 (2016-04)SIST EN 301 839 V2.1.1:2016en01-julij-2016SIST EN 301 839 V2.1.1:2016SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 2
Reference REN/ERM-TG30-306 Keywords radio, regulation ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00
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© European Telecommunications Standards Institute 2016. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 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 . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 11 3.3 Abbreviations . 12 4 Technical requirements specifications . 12 4.1 Environmental profile . 12 4.2 Conformance requirements . 12 4.2.1 Transmitter requirements . 12 4.2.1.1 Frequency error . 12 4.2.1.1.1 Definition. 12 4.2.1.1.2 Limits . 12 4.2.1.1.3 Conformance . 13 4.2.1.2 Emission bandwidth . 13 4.2.1.2.1 Definition. 13 4.2.1.2.2 Limits . 13 4.2.1.2.3 Conformance . 13 4.2.1.3 Effective radiated power of the fundamental emission . 13 4.2.1.3.1 Definition. 13 4.2.1.3.2 Limits . 13 4.2.1.3.3 Conformance . 13 4.2.1.4 Spurious emissions of transmitter . 14 4.2.1.4.1 Definition. 14 4.2.1.4.2 Limits . 14 4.2.1.4.3 Conformance . 14 4.2.1.5 Frequency stability under low voltage conditions . 14 4.2.1.5.1 Definition. 14 4.2.1.5.2 Limits . 14 4.2.1.5.3 Conformance . 14 4.2.2 Receiver requirements . 14 4.2.2.1 Spurious radiation of receivers . 14 4.2.2.1.1 Definition. 14 4.2.2.1.2 Limits . 14 4.2.2.1.3 Conformance . 15 4.2.3 Transmitter and Receiver requirements . 15 4.2.3.1 Spectrum Access . 15 4.2.3.1.0 General requirements . 15 4.2.3.1.1 LBT/AFA spectrum access . 15 4.2.3.1.2 LP/LDC spectrum access. 15 4.2.3.2 Receiver blocking . 16 4.2.3.2.1 Definition. 16 4.2.3.2.2 Limits . 16 4.2.3.2.3 Conformance . 16 4.3 Mechanical and electrical design . 16 4.3.1 General . 16 4.3.2 Antennas . 16 4.3.3 Controls . 17 SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 4 4.3.4 Transmitter shut-off facility . 17 5 Testing for compliance with technical requirements . 17 5.1 Environmental conditions for testing . 17 5.1.0 General provisions . 17 5.1.1 Presentation of equipment for testing purposes . 17 5.1.1.0
General provisions . 17 5.1.1.1 Choice of model for testing . 17 5.1.1.2 Testing of equipment with alternative power levels . 17 5.1.1.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 18 5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 18 5.1.1.3.2 Equipment with a temporary antenna connector . 18 5.1.1.3.3 Equipment intended to be implanted in a human body . 18 5.1.2 Declarations by the Applicant . 18 5.1.3 Auxiliary test equipment . 18 5.1.4 Test Conditions . 18 5.1.4.1 Normal and extreme test conditions . 18 5.1.4.2 Test power source . 18 5.1.4.2.0 General provisions . 18 5.1.4.2.1 External test power source . 19 5.1.4.2.2 Internal test power source . 19 5.1.4.3 Normal test conditions . 19 5.1.4.3.1 Normal temperature and humidity . 19 5.1.4.3.2 Normal test power source . 19 5.1.4.4 Extreme test conditions . 20 5.1.4.4.1 Extreme temperatures . 20 5.1.4.4.2 Extreme test source voltages . 21 5.1.4.5 Normal test signals and test modulation. 22 5.1.4.5.0 General provisions . 22 5.1.4.5.1 Normal modulation test signals for data . 22 5.1.4.6 Antennas . 22 5.1.4.6.0 General provisions . 22 5.1.4.6.1 Artificial antenna . 22 5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 22 5.1.4.7 Test fixture for ULP-AMI-P . 22 5.1.4.8 Test fixture for ULP-AMI . 23 5.1.4.9 Test sites and general arrangements for radiated measurements . 23 5.1.4.10 Modes of operation of the transmitter . 23 5.1.4.11 Measuring receiver . 23 5.2 Interpretation of the measurement results . 24 5.3 Methods of measurement . 25 5.3.1 Frequency error . 25 5.3.1.0 General provisions . 25 5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 25 5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 25 5.3.2 Emission bandwidth . 26 5.3.3 Effective radiated power of the fundamental emission . 26 5.3.4 Spurious emissions of transmitter . 27 5.3.5 Frequency stability under low voltage conditions . 29 5.3.6 Spurious radiation of receivers . 29 5.3.7 Spectrum Access . 30 5.3.7.1 LBT/AFA spectrum access . 30 5.3.7.1.0 General provisions . 30 5.3.7.1.1 Purpose . 30 5.3.7.1.2 General Remarks on the Measurement Configuration . 31 5.3.7.1.3 LBT threshold power level . 31 5.3.7.1.4 Monitoring system bandwidth . 32 5.3.7.1.5 Monitoring system scan cycle time and minimum channel monitoring period . 34 5.3.7.1.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 35 5.3.7.1.7 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs. 36 SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 5 5.3.7.1.8 Use of pre-scanned alternative channel . 36 5.3.8 Receiver blocking . 39 5.3.8.0 General remarks . 39 5.3.8.1 Measurement method using out-of-operating-region disturbance . 39 5.3.8.2 Measurement method using frequency administration commands . 40 5.3.8.3 Results based on the above test method . 40 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 41 Annex B (normative): Radiated measurements . 42 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 42 B.1.1 Outdoor test site . 42 B.1.1.0 Introduction. 42 B.1.1.1 Standard position . 42 B.1.1.2 Equipment in close proximity to the human body but external to it . 43 B.1.1.3 Human torso simulator for ULP-AMI . 43 B.1.2 Test antenna . 44 B.1.3 Substitution antenna . 44 B.1.4 Optional additional indoor site . 45 B.2 Guidance on the use of radiation test sites . 46 B.2.0 Introduction . 46 B.2.1 Measuring distance . 46 B.2.2 Test antenna . 46 B.2.3 Substitution antenna . 46 B.2.4 Artificial antenna . 46 B.2.5 Auxiliary cables . 46 B.3 Further optional alternative indoor test site using an anechoic chamber . 47 B.3.0 Introduction . 47 B.3.1 Example of the construction of a shielded anechoic chamber . 47 B.3.2 Influence of parasitic reflections in anechoic chambers . 47 B.3.3 Calibration of the shielded RF anechoic chamber . 48 Annex C (normative): Technical performance of the spectrum analyser . 50 Annex D (informative): Bibliography . 51 History . 52
ETSI ETSI EN 301 839 V2.1.1 (2016-04) 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.9] to provide one voluntary means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC [i.2]. Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations.
National transposition dates Date of adoption of this EN: 25 April 2016 Date of latest announcement of this EN (doa): 31 July 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 January 2017 Date of withdrawal of any conflicting National Standard (dow): 31 January 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 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 7 Introduction ULP-AMI/ULP-AMI-P equipment in the MICS service is an evolving technology, available worldwide in the medical field, that provides high speed communications capability between individuals with AIMDs and medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to individuals with various illnesses. Equipment in the MICS service consists of active medical implants that communicate to other active medical implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters. The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing the characteristics being measured are not expected to be affected. If equipment, which is available on the market, is required to be checked it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter, 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 5.3.7 specifies the required measurement methods. In particular clause 5.3.7.1 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.2]. 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 301 839 V2.1.1 (2016-04) 8 1 Scope The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI). • Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating frequency bands Transmit Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz
The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1]. It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz: • for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or • for telecommand and telemetry to/from an AIMD to another AIMD within the human body. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS) "… shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. 2 References 2.1 Normative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. Referenced documents which are not found to be publicly available in the expected location might be found at http://docbox.etsi.org/Reference. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are necessary for the application of the present document. [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". SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 9 2.2 Informative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. [i.1] ECC Decision (01)17 (2011 amendment): "Harmonised frequencies, technical characteristics and exemption from individual licensing of Ultra Low Power Active Medical Implant (ULP-AMI) communication systems operating in the frequency band 401 - 406 MHz on a secondary basis". [i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (RE-D). [i.3] ETSI TR 100 028 (all parts) (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". [i.4] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.5] 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/REC 74-01: "Unwanted Emissions in the Spurious Domain". [i.7] Recommendation ITU-R RS.1346: "Sharing between the meteorological aids service and medical implant communication systems (MICS) operating in the mobile service in the frequency band 401-406 MHz". [i.8] "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.9] 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. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: access protocol: specification for measuring natural and man-made ambient background levels for the purpose of providing a technique for spectrum access that reduces the potential for harmful interference to/from other users of the spectrum 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 Adaptive Frequency Agility (AFA): ability to determine and use an unoccupied sub-band or channel of operation in order to maximize spectrum utilization artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 10 conducted measurements: measurements that are made using a direct connection to the equipment under test 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 maximum transmitter "on" time monitored over one hour, relative to a one hour period NOTE: See clause 4.2.3.1.2.2. effective radiated power: power radiated within the emission bandwidth of the EUT in the direction of the maximum level under specified conditions of measurements in the presence of modulation or without modulation as appropriate NOTE: See clause 4.2.1.3.1. 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 NOTE: See clause 5.3.2 for details on how to determine compliance. frequency error: difference between the nominal frequency as measured on the devices under test and under normal test conditions and the frequency under extreme conditions NOTE: See also clause 4.2.1.1.1. frequency stability under low voltage condition: ability of the equipment to remain on the nominal operating frequency when the battery voltage falls below the lower extreme voltage level NOTE: See also clause 4.2.1.5.1. integral antenna: permanent fixed antenna, which may be built-in, designed as an indispensable part of the equipment LBT threshold power level: ambient signal power level above which the monitoring system selects spectrum for use in a MICS communication session according to the next available channel with the lowest level of ambient signal power or least interfered channel (LIC) Least Interfered Channel (LIC): channel, among the available channels that has the lowest potential for causing disturbance to or receiving disturbance from other users of the band NOTE: LIC may be used for spectrum selection provided the monitoring system has sufficient sensitivity to measure ambient signals at or below the LBT threshold power level. See clause 5.3.7.1.6. Listen Before Talk (LBT): combination of the listen mode followed by the talk mode listen mode: action taken by an interrogator to detect an unoccupied sub-band or channel Medical Device (MD): any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the: • diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; • investigation, replacement or modification of the anatomy or of a physiological process; • control of conception; and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means medical implant communication channel: Any continuous segment of spectrum that is equal to the emission bandwidth of the device with the largest bandwidth that is to participate in a MICL session. Aggregation of spectrum up to a maximum of 300 kHz for a single system is permitted. NOTE 1: As stated in ECC Decision (01)17 [i.1], it is permitted to combine adjacent channels for increased bandwidth up to 300 kHz. SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 11 NOTE 2: Two types of devices for Medical Implant Communications Systems are covered by the present document: (i) Frequency agile devices designed to access a minimum of nine channels evenly distributed across the 402 MHz to 405 MHz band. (ii) Single frequency devices restricted to the 403,5 MHz to 403,8 MHz centre channel. Medical Implant Communication Link (MICL): collection of transmissions that may or may not be continuous, between ULP-AMIs and ULP-AMI-Ps, including programmer/controllers, transferring patient related information in a communications service Medical Implant Communications System (MICS): system specifically for the purpose of providing non-voice digital communications between one or several ULP-AMI and one ULP-AMI-P or between ULP-AMI Medical Implant Communications System (MICS) session: collection of transmissions that may or may not be continuous, between co-operating ULP-AMI and ULP-AMI-P medical implant event: occurrence or the lack of an occurrence recognized by a medical implant device or duly authorized health care professional that requires the immediate transmission of data from a medical implant transmitter in order to protect the safety of the person in whom the medical implant transmitter has been placed NOTE: It is not permitted that this is the only mechanism a medical implant transmitter can use to access spectrum. monitoring system: circuitry in an ULP-AMI and/or ULP-AMI-P that assures conformity with the spectrum access protocol requirements based on Listen before Talk, Adaptive Frequency Agility and selection of the least interfered channel for operation (LIC) radiated measurements: measurements, which involve the absolute measurement of a radiated field spurious domain radiations from the receiver: components at any frequency, generated and radiated by active receiver circuitry and the antenna NOTE: See clause 4.2.2.1.1. talk mode: transmission of intentional radiation by a transmitter 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 time-critical data: data which if not transferred immediately will result in compromising the health and/or safety of the patient Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: the radio part of equipment outside the human body that communicates with an ULP-AMI to establish a MICL unwanted emissions: emissions in the spurious domain and out of band domain NOTE: See clause 4.2.1.4.1. 3.2 Symbols For the purposes of the present document, the following symbols apply: B bandwidth dB decibel E electrical field strength Eo reference electrical field strength (see annex B) f frequency fc channel centre frequency SIST EN 301 839 V2.1.1:2016

ETSI ETSI EN 301 839 V2.1.1 (2016-04) 12 fe frequency under extreme conditions G Antenna Gain NaCl sodium chloride P power R distance Ro Reference distance (see annex B) PTh maximum threshold power level (see clause 4.2.3.1.1.2) t time λ wavelength 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AFA Adaptive Frequency Agility AIMD Active Implantable Medical Device CW Continuous Wave e.r.p. effective radiated power EUT Equipment Under Test LBT Listen Before Talk LDC Low Duty Cycle LIC Least Interfered Channel LP Low Power MD Medical Device MICL Medical Implant Communication Link MICS Medical Implant Communications System RF Radio Frequency r.m.s. root mean square ULP-AMI Ultra Low Power Active Medical Implant ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral VSWR Voltage Standing Wave Ratio 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 Frequency error 4.2.1.1.1 Definition The frequency error, also known as frequency drift, is the difference between the nominal frequency as measured on the devices under test and under normal test conditions (see clause 5.1.4.3) and the frequency under extrem
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