ETSI EN 301 559-1 V1.1.2 (2012-06)

European Standard
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI)
operating in the frequency range 2 483,5 MHz to 2 500 MHz;
Part 1: Technical characteristics and test methods

2 ETSI EN 301 559-1 V1.1.2 (2012-06)

Reference
DEN/ERM-TG30-300
Keywords
EMC, health, radio, SRD, testing
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

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

Important notice
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive
within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
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Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2012.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP 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.
ETSI
3 ETSI EN 301 559-1 V1.1.2 (2012-06)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Technical requirements and specifications . 12
4.1 General requirements . 12
4.1.1 Transmitter requirements . 12
4.1.2 Receiver requirements . 12
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Spurious emission testing for composite equipment . 13
4.2.3 Testing of equipment with alternative power levels . 13
4.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 14
4.2.4.1 Equipment with an internal permanent or temporary antenna connector . 14
4.2.4.2 Equipment with a temporary antenna connector . 14
4.2.4.3 Equipment intended to be implanted in a human body . 14
4.3 Mechanical and electrical design . 14
4.3.1 General . 14
4.3.2 Controls . 14
4.3.3 Transmitter shut-off facility . 14
4.3.4 Marking . 14
4.3.5 Equipment identification . 14
4.4 Declarations by the Applicant . 15
4.5 Auxiliary test equipment . 15
4.6 Interpretation of the measurement results . 15
5 Test conditions, power sources and ambient temperatures . 15
5.1 Normal and extreme test conditions . 15
5.2 Test power source . 15
5.2.1 External test power source . 15
5.2.2 Internal test power source . 16
5.3 Normal test conditions . 16
5.3.1 Normal temperature and humidity . 16
5.3.2 Normal test power source . 16
5.3.2.1 Mains voltage . 16
5.3.2.2 Power sources . 16
5.4 Extreme test conditions . 17
5.4.1 Extreme temperatures . 17
5.4.1.1 Procedure for tests at extreme temperatures . 17
5.4.1.1.1 Procedure for equipment designed for continuous operation . 17
5.4.1.1.2 Procedure for equipment designed for intermittent operation . 17
5.4.1.2 Extreme temperature ranges . 17
5.4.2 Extreme test source voltages . 18
5.4.2.1 Mains voltage . 18
5.4.2.2 Power sources . 18
6 General conditions . 18
ETSI
4 ETSI EN 301 559-1 V1.1.2 (2012-06)
6.1 Normal test signals and test modulation . 18
6.1.1 Normal modulation test signals for data . 19
6.2 Antennas . 19
6.3 Artificial antenna . 19
6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector . 19
6.4 Test fixture for LP-AMI-P. 19
6.5 Test fixture for LP-AMI . 20
6.6 Test sites and general arrangements for radiated measurements . 20
6.7 Modes of operation of the transmitter . 20
6.8 Measuring receiver . 20
7 Measurement uncertainty . 21
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 22
8.1.1 Definition . 22
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23
8.1.1.2 Method of measurement for systems with a modulated output frequency . 23
8.1.2 Limit . 23
8.2 Emission bandwidth measurement . 23
8.2.1 Definition . 23
8.2.1.1 Method of measurement . 23
8.2.2 Limits . 24
8.3 Effective isotropic radiated power of the fundamental emission . 24
8.3.1 Definition . 24
8.3.1.1 Methods of measurement . 24
8.3.2 Limits . 25
8.4 Spurious emissions . 25
8.4.1 Definition . 25
8.4.1.1 Method of measuring the effective radiated power of spurious emissions. 25
8.4.2 Limits . 27
8.5 Out-of-band emissions . 27
8.5.1 Definition . 27
8.5.2 Methods of measurement . 27
8.5.3 Limits . 27
8.6 Frequency stability under low voltage conditions . 28
8.6.1 Definition . 28
8.6.1.1 Method of measurement . 28
8.6.2 Limits . 28
8.7 LP-AMI-P with restricted duty cycle . 28
8.7.1 Definitions . 28
8.7.2 Declaration of Duty Cycle . 28
8.7.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious radiation. 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious radiations. 29
9.1.2 Limits . 30
10 Requirements and Measuring Methods for Monitoring Systems . 31
10.1 Purpose . 31
10.2 General Remarks on the Measurement Configuration . 31
10.3 LBT threshold power level . 32
10.3.1 Measurement method using out-of-operating-region disturbance . 32
10.3.2 Measurement method using frequency administration commands . 33
10.3.3 Measurement method for LBT operation under interference condition . 33
10.3.4 Results based on above test method . 33
10.3.5 Limit . 33
10.4 Monitoring system bandwidth . 33
10.4.1 Measurement method using out-of-operating-region disturbance . 34
10.4.2 Measurement method using frequency administration commands . 34
10.4.3 Results based on above test method . 34
ETSI
5 ETSI EN 301 559-1 V1.1.2 (2012-06)
10.5 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.5.1 Measurement method using out-of-operating-region disturbance . 35
10.5.1.1 Scan cycle time . 35
10.5.1.2 Minimum channel monitoring period . 35
10.5.2 Measurement method using frequency administration commands . 35
10.5.3 Results based on above test method . 36
10.5.3.1 Scan cycle time . 36
10.5.3.2 Minimum Channel Monitoring Period . 36
10.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 36
Th
10.6.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 36
Th
10.6.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.6.3 Results based on above test method . 37
10.7 Discontinuation of AMICS session if a silent period greater than or equal to 5 seconds occurs . 37
10.7.1 Measurement method . 37
10.7.2 Results based on above test method . 37
10.8 Use of pre-scanned alternative channel . 38
10.8.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38
10.8.2 Measurement method for alternate channel selection using frequency administration commands . 39
10.8.3 Results based on above test method . 39
Annex A (normative): Radiated measurements . 41
A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 41
A.1.1 Outdoor test site . 41
A.1.1.1 Standard position . 41
A.1.1.2 Equipment in close proximity to the human body but external to it . 42
A.1.1.3 Applicative simulator . 42
A.1.1.3.1 General matters . 42
A.1.1.3.2 Vertical Human torso simulator for LP-AMI . 42
A.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 43
A.1.2 Test antenna . 44
A.1.3 Substitution antenna . 44
A.1.4 Optional additional indoor site . 45
A.2 Guidance on the use of radiation test sites . 46
A.2.1 Measuring distance . 46
A.2.2 Test antenna . 46
A.2.3 Substitution antenna . 46
A.2.4 Artificial antenna . 46
A.2.5 Auxiliary cables . 46
A.3 Further optional alternative indoor test site using an anechoic chamber . 47
A.3.1 Example of the construction of a shielded anechoic chamber . 47
A.3.2 Influence of parasitic reflections in anechoic chambers . 47
A.3.3 Calibration of the shielded RF anechoic chamber . 48
Annex B (informative): Bibliography . 50
History . 51

ETSI
6 ETSI EN 301 559-1 V1.1.2 (2012-06)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://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 European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and
Radio spectrum Matters (ERM).
For non EU countries the present document may be used for regulatory purposes.
The present document is part 1 of a multi-part deliverable covering Low Power Active Medical Implants (LP-AMI),
Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems
reference document for the equipment, TR 102 655 [i.8].
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".

National transposition dates
Date of adoption of this EN: 18 June 2012
Date of latest announcement of this EN (doa): 30 September 2012
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 March 2013
Date of withdrawal of any conflicting National Standard (dow): 31 March 2013

Introduction
LP-AMI/LP-AMI-P equipment in the AMICS is a unique new technology, that will provide for example 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
AMICS consists of LP-AMI and/or LP-AMI-P that provide human therapeutic and diagnostic data storage and analysis
capability.
The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and
Peripherals (LP-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.
ETSI
7 ETSI EN 301 559-1 V1.1.2 (2012-06)
Clause 4 provides a guide to requirements, the number of samples required in order that tests may be carried out and
any markings on the equipment that the provider has to supply.
Clauses 5 and 6 provide general test conditions to be used.
Clause 7 gives the maximum measurement uncertainty values.
Clauses 8, 9 and 10 specify spectrum utilization parameters and the measurement methods that are required for the
protection of the spectrum and patient. Clause 10 describes channel access requirements and methods. In particular
clause 10.1 describes the monitoring system performance specifications that have been chosen to minimize harmful
interference to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources
or other medical device users in the band and provide a high degree of link reliability in the interest of the patient.
Annex A (normative) provides specifications concerning radiated measurements.
Annex B (informative) bibliography; provides additional information.
ETSI
8 ETSI EN 301 559-1 V1.1.2 (2012-06)
1 Scope
The present document covers, for Low Power Active Medical Implants (LP-AMI), and associated Peripherals
(LP-AMI-P) used in an Active Medical Implant Communications System (AMICS), the required characteristics
considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices.
The specifications contained in the present document were developed to ensure that the health and safety of the patients
that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the
inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential
between AMICS operating in the band or between AMICS and other primary or secondary users of the band. Also
included in the present document is the capability of Low Duty Cycle/Low Power Access in the frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.7]: radio parts contained therein (referred to herein as
LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC [i.1]
(R&TTE Directive).
It is intended that the present document applies to operation in the band 2 483,5 MHz to 2 500 MHz that devices that
can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands.
The present document contains the technical characteristics for LP-AMI and associated peripherals radio equipment
which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 band f to that document. It does not necessarily
include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum
performance achievable.
It applies to LP-AMI and associated peripherals operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry to/from an LP-AMI in a patient's body to LP-AMI-P or between these
equipments;
• for telecommand and telemetry to/from an LP-AMI to another LP-AMI within the human body;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting an external dedicated antenna.
The present document covers requirements for radiated emissions above 30 MHz.
2 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
reference 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.
2.1 Normative references
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] 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".
ETSI
9 ETSI EN 301 559-1 V1.1.2 (2012-06)
2.2 Informative references
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 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio
equipment and telecommunications terminal equipment and the mutual recognition of their
conformity (R&TTE Directive).
[i.2] CEPT/ERC/REC 70-03 (2011): "Relating to the use of Short Range Devices (SRD)".
[i.3] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.4] 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.5] CEPT/ERC/REC 74-01: "Unwanted Emissions in the Spurious Domain".
[i.6] Simulated Biological.
[i.7] 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.8] ETSI TR 102 655: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI)
operating in a 20 MHz band within 2 360 MHz to 3 400 MHz".
[i.9] Hartsgrove and Kraszewski: "Composition And Electrical Properties Of A Liquid That Has The
Electrical Properties Of Tissue", 1984.
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 Medical Implant Communication Channel (AMICC): any continuous segment of spectrum that is equal to
the emission bandwidth of the device with the largest bandwidth that is to participate in an AMICL session
NOTE: The following type of devices for Active Medical Implant Communications Systems is covered by the
present document: Frequency agile devices (i.e. having implemented LBT&AFA) designed to access a
minimum one of 16 channels or 8 in the case of two channels dynamically aggregated for greater
instantaneous bandwidth, that are evenly distributed across the 2 483,5 MHz to 2 500 MHz band and
having Duty Cycle of less than 10 % for LP-AMI-P.
Active Medical Implant Communication Link (AMICL): collection of digitally modulated transmissions that may or
may not be continuous, between LP-AMIs, and LP-AMI-Ps transferring information in a communications system
Active Medical Implant Communications System (AMICS): system specifically for the purpose of providing
transmission of human therapeutic digital information between one or several LP-AMI and one or several LP-AMI-P
ETSI
10 ETSI EN 301 559-1 V1.1.2 (2012-06)
Active Medical Implant Communications System (AMICS) session: collection of transmissions that may or may not
be continuous, between a co-operating LP-AMI and LP-AMI-P
NOTE: Under normal operational circumstances the AMICS are allowed to be triggered, set-up and maintained
only by an LP-AMI-P acting as a master device. LP-AMI may attempt initiating the link only in cases of
emergencies, described as "medical implant event".
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 there for a long period after the procedure
Adaptive Frequency Agility (AFA): ability to determine and change to an unoccupied or least interfered sub-band or
channel of operation in order to maximize spectrum utilization
artificial antenna: reduced-radiation dummy load equal to the nominal impedance specified by the applicant
channel aggregation: combining two or more adjacent channels for greater bandwidth up to 2 MHz
composite equipment: any combined equipment made of two or more individual products or functions
NOTE: The individual products or functions in composite equipment might be subject to different technical
standards.
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 per
AMICS session, relative to a one hour period
NOTE: See clause 8.7.
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
effective isotropically radiated power (e.i.r.p.): product of the power supplied to the antenna and the antenna gain in a
given direction relative to an isotropic antenna
NOTE: See clause 8.3.
emission bandwidth: measured as the width of the signal between the points on either side of centre frequency that are
20 dB down relative to the maximum level of the modulated signal
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
frequency range: range of operating frequencies over which the equipment can be adjusted
NOTE: See also clause 8.1.1.
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 8.6.1.
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
an AMICS communication session according to the next available channel
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
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
ETSI
11 ETSI EN 301 559-1 V1.1.2 (2012-06)
Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an
equipment that communicates indoor with one or more LP-AMI to establish an AMICL
NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
Low Power Active Medical Implant (LP-AMI): the radio transmitting/receiving part of an AIMD inside the human
body
NOTE: LP-AMI transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
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
medical implant event: occurrence recognized by a medical implant system device 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 system transmitter has been placed
NOTE: An example of medical implant event is when the LP-AMI identifies the imminent critical health
condition of monitored patient. Cannot be used for scheduled data transmissions.
monitoring system: circuitry in an LP-AMI and/or LP-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) or the unoccupied sub-band or channel
out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission
bandwidth, which result from the modulation process, but excluding emissions in the spurious domain
spurious domain emissions: emissions at frequencies separated by more than 250 % of the occupied bandwidth from the
centre of the AMICC
spurious radiations from the receiver: components at any frequency, generated and radiated by active receiver
circuitry and the antenna
NOTE: See clause 9.1.1.
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 may result in compromising the health and/or safety of the
patient
transient power: power falling into adjacent spectrum due to switching the transmitter on and off during normal
operation (e.g. cyclic keying during data transmission)
unwanted emissions: emissions in the spurious domain and out of band emissions
3.2 Symbols
For the purposes of the present document, the following symbols apply:
B bandwidth
dB decibel
ETSI
12 ETSI EN 301 559-1 V1.1.2 (2012-06)
dBm absolute power level referred to one milliwatt
E electrical field strength
e.i.r.p. effective isotropically radiated power
f frequency
fc channel centre frequency
fe frequency under extreme conditions
G Antenna Gain
NaCl sodium chloride
P power
ppm parts per million
R distance
PTh maximum threshold power level (see clause 10)
T temperature
t time
λ wavelength
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AC Alternating Current
AFA Adaptive Frequency Agility
AIMD Active Implantable Medical Device
AMICC Active Medical Implant Communication Channel
AMICL Active Medical Implant Communication Link
AMICS Active Medical Implant Communications System
CW Continuous Wave
DC Direct Current
DUT Device Under Test
EUT Equipment Under Test
ICD Implantable Cardiac Defibrillator
LBT Listen Before Talk
L
...

Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)

European Standard
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Low Power Active Medical Implants (LP-AMI)
operating in the frequency range 2 483,5 MHz to 2 500 MHz;
Part 1: Technical characteristics and test methods

2 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)

Reference
DEN/ERM-TG30-300
Keywords
EMC, health, radio, SRD, testing
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

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

Important notice
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive
within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2012.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP 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.
ETSI
3 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 12
4 Technical requirements and specifications . 12
4.1 General requirements . 12
4.1.1 Transmitter requirements . 12
4.1.2 Receiver requirements . 12
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Spurious emission testing for composite equipment . 13
4.2.3 Testing of equipment with alternative power levels . 13
4.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 14
4.2.4.1 Equipment with an internal permanent or temporary antenna connector . 14
4.2.4.2 Equipment with a temporary antenna connector . 14
4.2.4.3 Equipment intended to be implanted in a human body . 14
4.3 Mechanical and electrical design . 14
4.3.1 General . 14
4.3.2 Controls . 14
4.3.3 Transmitter shut-off facility . 14
4.3.4 Marking . 14
4.3.5 Equipment identification . 14
4.4 Declarations by the Applicant . 15
4.5 Auxiliary test equipment . 15
4.6 Interpretation of the measurement results . 15
5 Test conditions, power sources and ambient temperatures . 15
5.1 Normal and extreme test conditions . 15
5.2 Test power source . 15
5.2.1 External test power source . 15
5.2.2 Internal test power source . 16
5.3 Normal test conditions . 16
5.3.1 Normal temperature and humidity . 16
5.3.2 Normal test power source . 16
5.3.2.1 Mains voltage . 16
5.3.2.2 Power sources . 16
5.4 Extreme test conditions . 17
5.4.1 Extreme temperatures . 17
5.4.1.1 Procedure for tests at extreme temperatures . 17
5.4.1.1.1 Procedure for equipment designed for continuous operation . 17
5.4.1.1.2 Procedure for equipment designed for intermittent operation . 17
5.4.1.2 Extreme temperature ranges . 17
5.4.2 Extreme test source voltages . 18
5.4.2.1 Mains voltage . 18
5.4.2.2 Power sources . 18
6 General conditions . 18
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4 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
6.1 Normal test signals and test modulation . 18
6.1.1 Normal modulation test signals for data . 19
6.2 Antennas . 19
6.3 Artificial antenna . 19
6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector . 19
6.4 Test fixture for LP-AMI-P. 19
6.5 Test fixture for LP-AMI . 20
6.6 Test sites and general arrangements for radiated measurements . 20
6.7 Modes of operation of the transmitter . 20
6.8 Measuring receiver . 20
7 Measurement uncertainty . 21
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 22
8.1.1 Definition . 22
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23
8.1.1.2 Method of measurement for systems with a modulated output frequency . 23
8.1.2 Limit . 23
8.2 Emission bandwidth measurement . 23
8.2.1 Definition . 23
8.2.1.1 Method of measurement . 23
8.2.2 Limits . 24
8.3 Effective isotropic radiated power of the fundamental emission . 24
8.3.1 Definition . 24
8.3.1.1 Methods of measurement . 24
8.3.2 Limits . 25
8.4 Spurious emissions . 25
8.4.1 Definition . 25
8.4.1.1 Method of measuring the effective radiated power of spurious emissions. 25
8.4.2 Limits . 27
8.5 Out-of-band emissions . 27
8.5.1 Definition . 27
8.5.2 Methods of measurement . 27
8.5.3 Limits . 27
8.6 Frequency stability under low voltage conditions . 28
8.6.1 Definition . 28
8.6.1.1 Method of measurement . 28
8.6.2 Limits . 28
8.7 LP-AMI-P with restricted duty cycle . 28
8.7.1 Definitions . 28
8.7.2 Declaration of Duty Cycle . 28
8.7.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious radiation. 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious radiations. 29
9.1.2 Limits . 30
10 Requirements and Measuring Methods for Monitoring Systems . 31
10.1 Purpose . 31
10.2 General Remarks on the Measurement Configuration . 31
10.3 LBT threshold power level . 32
10.3.1 Measurement method using out-of-operating-region disturbance . 32
10.3.2 Measurement method using frequency administration commands . 33
10.3.3 Measurement method for LBT operation under interference condition . 33
10.3.4 Results based on above test method . 33
10.3.5 Limit . 33
10.4 Monitoring system bandwidth . 33
10.4.1 Measurement method using out-of-operating-region disturbance . 34
10.4.2 Measurement method using frequency administration commands . 34
10.4.3 Results based on above test method . 34
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5 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
10.5 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.5.1 Measurement method using out-of-operating-region disturbance . 35
10.5.1.1 Scan cycle time . 35
10.5.1.2 Minimum channel monitoring period . 35
10.5.2 Measurement method using frequency administration commands . 35
10.5.3 Results based on above test method . 36
10.5.3.1 Scan cycle time . 36
10.5.3.2 Minimum Channel Monitoring Period . 36
10.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 36
Th
10.6.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 36
Th
10.6.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.6.3 Results based on above test method . 37
10.7 Discontinuation of AMICS session if a silent period greater than or equal to 5 seconds occurs . 37
10.7.1 Measurement method . 37
10.7.2 Results based on above test method . 37
10.8 Use of pre-scanned alternative channel . 38
10.8.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38
10.8.2 Measurement method for alternate channel selection using frequency administration commands . 39
10.8.3 Results based on above test method . 39
Annex A (normative): Radiated measurements . 41
A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 41
A.1.1 Outdoor test site . 41
A.1.1.1 Standard position . 41
A.1.1.2 Equipment in close proximity to the human body but external to it . 42
A.1.1.3 Applicative simulator . 42
A.1.1.3.1 General matters . 42
A.1.1.3.2 Vertical Human torso simulator for LP-AMI . 42
A.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 43
A.1.2 Test antenna . 44
A.1.3 Substitution antenna . 44
A.1.4 Optional additional indoor site . 45
A.2 Guidance on the use of radiation test sites . 46
A.2.1 Measuring distance . 46
A.2.2 Test antenna . 46
A.2.3 Substitution antenna . 46
A.2.4 Artificial antenna . 46
A.2.5 Auxiliary cables . 46
A.3 Further optional alternative indoor test site using an anechoic chamber . 47
A.3.1 Example of the construction of a shielded anechoic chamber . 47
A.3.2 Influence of parasitic reflections in anechoic chambers . 47
A.3.3 Calibration of the shielded RF anechoic chamber . 47
Annex B (informative): Bibliography . 50
History . 51

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6 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
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 (http://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 final draft European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the Vote phase of the ETSI standards Two-
step Approval Procedure.
For non EU countries the present document may be used for regulatory purposes.
The present document is part 1 of a multi-part deliverable covering Low Power Active Medical Implants (LP-AMI),
Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems
reference document for the equipment, TR 102 655 [i.8].
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 6 months after doa

Introduction
LP-AMI/LP-AMI-P equipment in the AMICS is a unique new technology, that will provide for example 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
AMICS consists of LP-AMI and/or LP-AMI-P that provide human therapeutic and diagnostic data storage and analysis
capability.
The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and
Peripherals (LP-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.
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7 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
Clause 4 provides a guide to requirements, the number of samples required in order that tests may be carried out and
any markings on the equipment that the provider has to supply.
Clauses 5 and 6 provide general test conditions to be used.
Clause 7 gives the maximum measurement uncertainty values.
Clauses 8, 9 and 10 specify spectrum utilization parameters and the measurement methods that are required for the
protection of the spectrum and patient. Clause 10 describes channel access requirements and methods. In particular
clause 10.1 describes the monitoring system performance specifications that have been chosen to minimize harmful
interference to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources
or other medical device users in the band and provide a high degree of link reliability in the interest of the patient.
Annex A (normative) provides specifications concerning radiated measurements.
Annex B (informative) bibliography; provides additional information.
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8 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
1 Scope
The present document covers, for Low Power Active Medical Implants (LP-AMI), and associated Peripherals
(LP-AMI-P) used in an Active Medical Implant Communications System (AMICS), the required characteristics
considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices.
The specifications contained in the present document were developed to ensure that the health and safety of the patients
that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the
inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential
between AMICS operating in the band or between AMICS and other primary or secondary users of the band. Also
included in the present document is the capability of Low Duty Cycle/Low Power Access in the frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.7]: radio parts contained therein (referred to herein as
LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC [i.1]
(R&TTE Directive).
It is intended that the present document applies to operation in the band 2 483,5 MHz to 2 500 MHz that devices that
can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands.
The present document contains the technical characteristics for LP-AMI and associated peripherals radio equipment
which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 band f to that document. It does not necessarily
include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum
performance achievable.
It applies to LP-AMI and associated peripherals operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry to/from an LP-AMI in a patient's body to LP-AMI-P or between these
equipments;
• for telecommand and telemetry to/from an LP-AMI to another LP-AMI within the human body;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting an external dedicated antenna.
The present document covers requirements for radiated emissions above 30 MHz.
2 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
reference 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.
2.1 Normative references
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] 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".
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9 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
2.2 Informative references
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 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio
equipment and telecommunications terminal equipment and the mutual recognition of their
conformity (R&TTE Directive).
[i.2] CEPT/ERC/REC 70-03 (2011): "Relating to the use of Short Range Devices (SRD)".
[i.3] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.4] 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.5] CEPT/ERC/REC 74-01: "Unwanted Emissions in the Spurious Domain".
[i.6] Simulated Biological.
[i.7] 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.8] ETSI TR 102 655: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI)
operating in a 20 MHz band within 2 360 MHz to 3 400 MHz".
[i.9] Hartsgrove and Kraszewski: "Composition And Electrical Properties Of A Liquid That Has The
Electrical Properties Of Tissue", 1984.
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 Medical Implant Communication Channel (AMICC): any continuous segment of spectrum that is equal to
the emission bandwidth of the device with the largest bandwidth that is to participate in an AMICL session
NOTE: The following type of devices for Active Medical Implant Communications Systems is covered by the
present document: Frequency agile devices (i.e. having implemented LBT&AFA) designed to access a
minimum one of 16 channels or 8 in the case of two channels dynamically aggregated for greater
instantaneous bandwidth, that are evenly distributed across the 2 483,5 MHz to 2 500 MHz band and
having Duty Cycle of less than 10 % for LP-AMI-P.
Active Medical Implant Communication Link (AMICL): collection of digitally modulated transmissions that may or
may not be continuous, between LP-AMIs, and LP-AMI-Ps transferring information in a communications system
Active Medical Implant Communications System (AMICS): system specifically for the purpose of providing
transmission of human therapeutic digital information between one or several LP-AMI and one or several LP-AMI-P
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10 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
Active Medical Implant Communications System (AMICS) session: collection of transmissions that may or may not
be continuous, between a co-operating LP-AMI and LP-AMI-P
NOTE: Under normal operational circumstances the AMICS are allowed to be triggered, set-up and maintained
only by an LP-AMI-P acting as a master device. LP-AMI may attempt initiating the link only in cases of
emergencies, described as "medical implant event".
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 there for a long period after the procedure
Adaptive Frequency Agility (AFA): ability to determine and change to an unoccupied or least interfered sub-band or
channel of operation in order to maximize spectrum utilization
artificial antenna: reduced-radiation dummy load equal to the nominal impedance specified by the applicant
channel aggregation: combining two or more adjacent channels for greater bandwidth up to 2 MHz
composite equipment: any combined equipment made of two or more individual products or functions
NOTE: The individual products or functions in composite equipment might be subject to different technical
standards.
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 per
AMICS session, relative to a one hour period
NOTE: See clause 8.7.
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
effective isotropically radiated power (e.i.r.p.): product of the power supplied to the antenna and the antenna gain in a
given direction relative to an isotropic antenna
NOTE: See clause 8.3.
emission bandwidth: measured as the width of the signal between the points on either side of centre frequency that are
20 dB down relative to the maximum level of the modulated signal
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
frequency range: range of operating frequencies over which the equipment can be adjusted
NOTE: See also clause 8.1.1.
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 8.6.1.
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
an AMICS communication session according to the next available channel
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
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
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11 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an
equipment that communicates indoor with one or more LP-AMI to establish an AMICL
NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
Low Power Active Medical Implant (LP-AMI): the radio transmitting/receiving part of an AIMD inside the human
body
NOTE: LP-AMI transmissions are allowed without limitation in cases of emergencies, described as "medical
implant event".
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
medical implant event: occurrence recognized by a medical implant system device 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 system transmitter has been placed
NOTE: An example of medical implant event is when the LP-AMI identifies the imminent critical health
condition of monitored patient. Cannot be used for scheduled data transmissions.
monitoring system: circuitry in an LP-AMI and/or LP-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) or the unoccupied sub-band or channel
out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission
bandwidth, which result from the modulation process, but excluding emissions in the spurious domain
spurious domain emissions: emissions at frequencies separated by more than 250 % of the occupied bandwidth from the
centre of the AMICC
spurious radiations from the receiver: components at any frequency, generated and radiated by active receiver
circuitry and the antenna
NOTE: See clause 9.1.1.
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 may result in compromising the health and/or safety of the
patient
transient power: power falling into adjacent spectrum due to switching the transmitter on and off during normal
operation (e.g. cyclic keying during data transmission)
unwanted emissions: emissions in the spurious domain and out of band emissions
3.2 Symbols
For the purposes of the present document, the following symbols apply:
B bandwidth
dB decibel
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12 Final draft ETSI EN 301 559-1 V1.1.2 (2012-04)
dBm absolute power level referred to one milliwatt
E electrical field strength
e.i.r.p. effective isotropically radiated power
f frequency
fc channel centre frequency
fe frequency under extreme conditions
G Antenna Gain
NaCl sodium chloride
P power
ppm parts per million
R distance
PTh maximum threshold power level (see clause 10)
T temperature
t time
λ wavelength
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AC Alternating Current
AFA Adaptive Frequency Agility
AIMD Active Implantable Medical Device
AMICC Active Medical Implant Communication Channel
AMICL Active M
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.01Radijske komunikacije na splošnoRadiocommunications in generalICS:Ta slovenski standard je istoveten z:EN 301 559-1 Version 1.1.2SIST EN 301 559-1 V1.1.2:2012en01-september-2012SIST EN 301 559-1 V1.1.2:2012SLOVENSKI
STANDARD
European Standard SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 2
Reference DEN/ERM-TG30-300 Keywords EMC, health, radio, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00
Fax: +33 4 93 65 47 16
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Important notice Individual copies of the present document can be downloaded from: http://www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is available at http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to one of the following services: http://portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2012. 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 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Introduction . 6 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 11 3.3 Abbreviations . 12 4 Technical requirements and specifications . 12 4.1 General requirements . 12 4.1.1 Transmitter requirements . 12 4.1.2 Receiver requirements . 12 4.2 Presentation of equipment for testing purposes . 13 4.2.1 Choice of model for testing . 13 4.2.2 Spurious emission testing for composite equipment . 13 4.2.3 Testing of equipment with alternative power levels . 13 4.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 14 4.2.4.1 Equipment with an internal permanent or temporary antenna connector . 14 4.2.4.2 Equipment with a temporary antenna connector . 14 4.2.4.3 Equipment intended to be implanted in a human body . 14 4.3 Mechanical and electrical design . 14 4.3.1 General . 14 4.3.2 Controls . 14 4.3.3 Transmitter shut-off facility . 14 4.3.4 Marking . 14 4.3.5 Equipment identification . 14 4.4 Declarations by the Applicant . 15 4.5 Auxiliary test equipment . 15 4.6 Interpretation of the measurement results . 15 5 Test conditions, power sources and ambient temperatures . 15 5.1 Normal and extreme test conditions . 15 5.2 Test power source . 15 5.2.1 External test power source . 15 5.2.2 Internal test power source . 16 5.3 Normal test conditions . 16 5.3.1 Normal temperature and humidity . 16 5.3.2 Normal test power source . 16 5.3.2.1 Mains voltage . 16 5.3.2.2 Power sources . 16 5.4 Extreme test conditions . 17 5.4.1 Extreme temperatures . 17 5.4.1.1 Procedure for tests at extreme temperatures . 17 5.4.1.1.1 Procedure for equipment designed for continuous operation . 17 5.4.1.1.2 Procedure for equipment designed for intermittent operation . 17 5.4.1.2 Extreme temperature ranges . 17 5.4.2 Extreme test source voltages . 18 5.4.2.1 Mains voltage . 18 5.4.2.2 Power sources . 18 6 General conditions . 18 SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 4 6.1 Normal test signals and test modulation . 18 6.1.1 Normal modulation test signals for data . 19 6.2 Antennas . 19 6.3 Artificial antenna . 19 6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector . 19 6.4 Test fixture for LP-AMI-P. 19 6.5 Test fixture for LP-AMI . 20 6.6 Test sites and general arrangements for radiated measurements . 20 6.7 Modes of operation of the transmitter . 20 6.8 Measuring receiver . 20 7 Measurement uncertainty . 21 8 Methods of measurement and limits for transmitter parameters . 22 8.1 Frequency error . 22 8.1.1 Definition . 22 8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23 8.1.1.2 Method of measurement for systems with a modulated output frequency . 23 8.1.2 Limit . 23 8.2 Emission bandwidth measurement . 23 8.2.1 Definition . 23 8.2.1.1 Method of measurement . 23 8.2.2 Limits . 24 8.3 Effective isotropic radiated power of the fundamental emission . 24 8.3.1 Definition . 24 8.3.1.1 Methods of measurement . 24 8.3.2 Limits . 25 8.4 Spurious emissions . 25 8.4.1 Definition . 25 8.4.1.1 Method of measuring the effective radiated power of spurious emissions. 25 8.4.2 Limits . 27 8.5 Out-of-band emissions . 27 8.5.1 Definition . 27 8.5.2 Methods of measurement . 27 8.5.3 Limits . 27 8.6 Frequency stability under low voltage conditions . 28 8.6.1 Definition . 28 8.6.1.1 Method of measurement . 28 8.6.2 Limits . 28 8.7 LP-AMI-P with restricted duty cycle . 28 8.7.1 Definitions . 28 8.7.2 Declaration of Duty Cycle . 28 8.7.3 Limit for duty cycle and maximum number of transmissions . 29 9 Methods of measurement and limits for receiver parameters . 29 9.1 Spurious radiation. 29 9.1.1 Definition . 29 9.1.1.1 Method of measuring the effective radiated power of spurious radiations. 29 9.1.2 Limits . 30 10 Requirements and Measuring Methods for Monitoring Systems . 31 10.1 Purpose . 31 10.2 General Remarks on the Measurement Configuration . 31 10.3 LBT threshold power level . 32 10.3.1 Measurement method using out-of-operating-region disturbance . 32 10.3.2 Measurement method using frequency administration commands . 33 10.3.3 Measurement method for LBT operation under interference condition . 33 10.3.4 Results based on above test method . 33 10.3.5 Limit . 33 10.4 Monitoring system bandwidth . 33 10.4.1 Measurement method using out-of-operating-region disturbance . 34 10.4.2 Measurement method using frequency administration commands . 34 10.4.3 Results based on above test method . 34 SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 5 10.5 Monitoring system scan cycle time and minimum channel monitoring period . 35 10.5.1 Measurement method using out-of-operating-region disturbance . 35 10.5.1.1 Scan cycle time . 35 10.5.1.2 Minimum channel monitoring period . 35 10.5.2 Measurement method using frequency administration commands . 35 10.5.3 Results based on above test method . 36 10.5.3.1 Scan cycle time . 36 10.5.3.2 Minimum Channel Monitoring Period . 36 10.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 36 10.6.1 Access based on lowest ambient level above PTh using out-of-operating-region disturbance . 36 10.6.2 Access based on lowest ambient level above PTh using frequency administration commands . 37 10.6.3 Results based on above test method . 37 10.7 Discontinuation of AMICS session if a silent period greater than or equal to 5 seconds occurs . 37 10.7.1 Measurement method . 37 10.7.2 Results based on above test method . 37 10.8 Use of pre-scanned alternative channel . 38 10.8.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38 10.8.2 Measurement method for alternate channel selection using frequency administration commands . 39 10.8.3 Results based on above test method . 39 Annex A (normative): Radiated measurements . 41 A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 41 A.1.1 Outdoor test site . 41 A.1.1.1 Standard position . 41 A.1.1.2 Equipment in close proximity to the human body but external to it . 42 A.1.1.3 Applicative simulator . 42 A.1.1.3.1 General matters . 42 A.1.1.3.2 Vertical Human torso simulator for LP-AMI . 42 A.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 43 A.1.2 Test antenna . 44 A.1.3 Substitution antenna . 44 A.1.4 Optional additional indoor site . 45 A.2 Guidance on the use of radiation test sites . 46 A.2.1 Measuring distance . 46 A.2.2 Test antenna . 46 A.2.3 Substitution antenna . 46 A.2.4 Artificial antenna . 46 A.2.5 Auxiliary cables . 46 A.3 Further optional alternative indoor test site using an anechoic chamber . 47 A.3.1 Example of the construction of a shielded anechoic chamber . 47 A.3.2 Influence of parasitic reflections in anechoic chambers . 47 A.3.3 Calibration of the shielded RF anechoic chamber . 48 Annex B (informative): Bibliography . 50 History . 51
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 6 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http://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 European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). For non EU countries the present document may be used for regulatory purposes. The present document is part 1 of a multi-part deliverable covering Low Power Active Medical Implants (LP-AMI), Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems reference document for the equipment, TR 102 655 [i.8]. Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 18 June 2012 Date of latest announcement of this EN (doa): 30 September 2012 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2013 Date of withdrawal of any conflicting National Standard (dow): 31 March 2013
Introduction LP-AMI/LP-AMI-P equipment in the AMICS is a unique new technology, that will provide for example 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 AMICS consists of LP-AMI and/or LP-AMI-P that provide human therapeutic and diagnostic data storage and analysis capability. The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and Peripherals (LP-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. SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 7 Clause 4 provides a guide to requirements, the number of samples required in order that tests may be carried out and any markings on the equipment that the provider has to supply. Clauses 5 and 6 provide general test conditions to be used. Clause 7 gives the maximum measurement uncertainty values. Clauses 8, 9 and 10 specify spectrum utilization parameters and the measurement methods that are required for the protection of the spectrum and patient. Clause 10 describes channel access requirements and methods. In particular clause 10.1 describes the monitoring system performance specifications that have been chosen to minimize harmful interference to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources or other medical device users in the band and provide a high degree of link reliability in the interest of the patient. Annex A (normative) provides specifications concerning radiated measurements. Annex B (informative) bibliography; provides additional information. SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 8 1 Scope The present document covers, for Low Power Active Medical Implants (LP-AMI), and associated Peripherals (LP-AMI-P) used in an
Active Medical Implant Communications System (AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential between AMICS operating in the band or between AMICS and other primary or secondary users of the band. Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.7]: radio parts contained therein (referred to herein as LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC [i.1] (R&TTE Directive). It is intended that the present document applies to operation in the band 2 483,5 MHz to 2 500 MHz that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for LP-AMI and associated peripherals radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 band f to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. It applies to LP-AMI and associated peripherals operating in the band 2 483,5 MHz to 2 500 MHz: • for telecommand and telemetry to/from an LP-AMI in a patient's body to LP-AMI-P or between these equipments; • for telecommand and telemetry to/from an LP-AMI to another LP-AMI within the human body; • with or without an integral antenna; and/or • with an antenna connection provided only for the purpose of connecting an external dedicated antenna. The present document covers requirements for radiated emissions above 30 MHz. 2 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 reference 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. 2.1 Normative references 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] 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". SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 9 2.2 Informative references 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 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R&TTE Directive). [i.2] CEPT/ERC/REC 70-03 (2011): "Relating to the use of Short Range Devices (SRD)". [i.3] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.4] 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.5] CEPT/ERC/REC 74-01: "Unwanted Emissions in the Spurious Domain". [i.6] Simulated Biological. [i.7] 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.8] ETSI TR 102 655: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in a 20 MHz band within 2 360 MHz to 3 400 MHz". [i.9] Hartsgrove and Kraszewski: "Composition And Electrical Properties Of A Liquid That Has The Electrical Properties Of Tissue", 1984. 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 Medical Implant Communication Channel (AMICC): any continuous segment of spectrum that is equal to the emission bandwidth of the device with the largest bandwidth that is to participate in an AMICL session NOTE: The following type of devices for Active Medical Implant Communications Systems is covered by the present document: Frequency agile devices (i.e. having implemented LBT&AFA) designed to access a minimum one of 16 channels or 8 in the case of two channels dynamically aggregated for greater instantaneous bandwidth, that are evenly distributed across the 2 483,5 MHz to 2 500 MHz band and having Duty Cycle of less than 10 % for LP-AMI-P. Active Medical Implant Communication Link (AMICL): collection of digitally modulated transmissions that may or may not be continuous, between LP-AMIs, and LP-AMI-Ps transferring information in a communications system Active Medical Implant Communications System (AMICS): system specifically for the purpose of providing transmission of human therapeutic digital information between one or several LP-AMI and one or several LP-AMI-P SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 10 Active Medical Implant Communications System (AMICS) session: collection of transmissions that may or may not be continuous, between a co-operating LP-AMI and LP-AMI-P NOTE: Under normal operational circumstances the AMICS are allowed to be triggered, set-up and maintained only by an LP-AMI-P acting as a master device. LP-AMI may attempt initiating the link only in cases of emergencies, described as "medical implant event". 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 there for a long period after the procedure Adaptive Frequency Agility (AFA): ability to determine and change to an unoccupied or least interfered sub-band or channel of operation in order to maximize spectrum utilization artificial antenna: reduced-radiation dummy load equal to the nominal impedance specified by the applicant channel aggregation: combining two or more adjacent channels for greater bandwidth up to 2 MHz composite equipment: any combined equipment made of two or more individual products or functions NOTE: The individual products or functions in composite equipment might be subject to different technical standards. 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 per AMICS session, relative to a one hour period NOTE: See clause 8.7. 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 effective isotropically radiated power (e.i.r.p.): product of the power supplied to the antenna and the antenna gain in a given direction relative to an isotropic antenna NOTE: See clause 8.3. emission bandwidth: measured as the width of the signal between the points on either side of centre frequency that are 20 dB down relative to the maximum level of the modulated signal 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 frequency range: range of operating frequencies over which the equipment can be adjusted NOTE: See also clause 8.1.1. 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 8.6.1. 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 an AMICS communication session according to the next available channel 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 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 SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 11 Low Power Active Medical Implant Peripheral (LP-AMI-P) device: the radio transmitting/receiving part of an equipment that communicates indoor with one or more LP-AMI to establish an AMICL NOTE: LP-AMI-P transmissions are allowed without limitation in cases of emergencies, described as "medical implant event". Low Power Active Medical Implant (LP-AMI): the radio transmitting/receiving part of an AIMD inside the human body NOTE: LP-AMI transmissions are allowed without limitation in cases of emergencies, described as "medical implant event". 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 medical implant event: occurrence recognized by a medical implant system device 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 system transmitter has been placed NOTE: An example of medical implant event is when the LP-AMI identifies the imminent critical health condition of monitored patient. Cannot be used for scheduled data transmissions. monitoring system: circuitry in an LP-AMI and/or LP-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) or the unoccupied sub-band or channel out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission bandwidth, which result from the modulation process, but excluding emissions in the spurious domain spurious domain emissions: emissions at frequencies separated by more than 250 % of the occupied bandwidth from the centre of the AMICC spurious radiations from the receiver: components at any frequency, generated and radiated by active receiver circuitry and the antenna NOTE: See clause 9.1.1. 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 may result in compromising the health and/or safety of the patient transient power: power falling into adjacent spectrum due to switching the transmitter on and off during normal operation (e.g. cyclic keying during data transmission) unwanted emissions: emissions in the spurious domain and out of band emissions 3.2 Symbols For the purposes of the present document, the following symbols apply: B bandwidth dB decibel SIST EN 301 559-1 V1.1.2:2012

ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 12 dBm absolute power level referred to one milliwatt E electrical field strength e.i.r.p. effective isotropically radiated power f frequency fc channel centre frequency fe frequency under extreme conditions G Antenna Gain NaCl sodium chloride P power ppm parts per million R distance PTh maximum threshold power level (see clause 10) T temperature t time λ wavelength 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AC Alternating Current AFA Adaptive Frequency Agility AIMD Active Implantable Medical Device AMICC Active Medical Implant Communication Channel AMICL Active Medical Implant Communication Link AMICS Active Medical Implant Communications System CW Continuous Wave DC Direct Current DUT Device Under Test EUT Equipment Under Test ICD Implantable Cardiac Defibrillator LBT Listen Before Talk LIC Least Interfered Channel LP Low Power LP-AMI Low Powe
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