ETSI EN 301 839-1 V1.3.1 (2009-10)
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteristics and test methods
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteristics and test methods
REN/ERM-TG30-263-1
Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Naprave kratkega dosega (SRD) - Aktivni medicinski vsadki ultra majhnih moči (ULP-AMI) in pripadajoče periferne naprave (ULP-AMI-P), ki delujejo v frekvenčnem območju od 402 MHz do 405 MHz - 1. del: Tehnične karakteristike in preskusne metode
General Information
Standards Content (Sample)
Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
European Standard (Telecommunications series)
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 1: Technical characteristics and test methods
2 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
Reference
REN/ERM-TG30-263-1
Keywords
radio, SRD, testing
ETSI
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3 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
4.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13
4.2.3.1 Equipment with an internal permanent or temporary antenna connector . 13
4.2.3.2 Equipment with a temporary antenna connector . 14
4.2.3.3 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 . 14
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 Regulated lead-acid battery power sources . 16
5.3.2.3 Other 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 . 18
5.4.2 Extreme test source voltages . 18
5.4.2.1 Mains voltage . 18
5.4.2.2 Regulated lead-acid battery power sources . 18
5.4.2.3 Power sources using other types of batteries . 18
5.4.2.4 Other power sources . 19
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4 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
6 General conditions . 19
6.1 Normal test signals and test modulation . 19
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 20
6.6 Test sites and general arrangements for radiated measurements . 20
6.7 Modes of operation of the transmitter . 21
6.8 Measuring receiver . 21
7 Measurement uncertainty . 21
8 Methods of measurement and limits for transmitter parameters . 22
8A Introduction . 22
8.1 Frequency error . 22
8.1.1 Definition . 23
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 carrier frequency . 23
8.1.2 Limit . 23
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
8.2.2 Limits . 24
8.3 Effective radiated power of the fundamental emission . 24
8.3.1 Definition . 24
8.3.1.1 Methods of measurement . 25
8.3.2 Limits . 26
8.4 Spurious emissions . 26
8.4.1 Definition . 26
8.4.1.1 Method of measuring the effective radiated power of spurious emissions. 26
8.4.2 Limits . 27
8.5 Frequency stability under low voltage conditions . 27
8.5.1 Definition . 27
8.5.1.1 Method of measurement . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 28
9 Methods of measurement and limits for receiver parameters . 28
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 . 30
10A Purpose . 30
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 31
10.1.1 Measurement method using out-of-operating-region disturbance . 32
10.1.2 Measurement method using frequency administration commands . 32
10.1.3 Results based on above test method . 32
10.1.4 Limit . 33
10.2 Monitoring system bandwidth . 33
10.2.1 Measurement method using out-of-operating-region disturbance . 33
10.2.2 Measurement method using frequency administration commands . 34
10.2.3 Results based on above test method . 34
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 34
10.3.1 Measurement method using out-of-operating-region disturbance . 34
10.3.1.1 Scan cycle time . 34
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5 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
10.3.1.2 Minimum channel monitoring period . 35
10.3.2 Measurement method using frequency administration commands . 35
10.3.3 Results based on above test method . 35
10.3.3.1 Scan cycle time . 35
10.3.3.2 Minimum Channel Monitoring Period . 35
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 36
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 36
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 36
Th
10.4.3 Results based on above test method . 37
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 s occurs . 37
10.5.1 Measurement method . 37
10.5.2 Results based on above test method . 37
10.6 Use of pre-scanned alternate channel . 37
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 39
10.6.3 Results based on above test method . 39
Annex A (normative): Radiated measurements . 40
A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 40
A.1.1 Outdoor test site . 40
A.1.1.1 Standard position . 40
A.1.1.2 Equipment in close proximity to the human body but external to it . 41
A.1.1.3 Human torso simulator for ULP-AMI . 41
A.1.2 Test antenna . 42
A.1.3 Substitution antenna . 42
A.1.4 Optional additional indoor site . 43
A.2 Guidance on the use of radiation test sites . 44
A.2.1 Measuring distance . 44
A.2.2 Test antenna . 44
A.2.3 Substitution antenna . 44
A.2.4 Artificial antenna . 44
A.2.5 Auxiliary cables . 44
A.3 Further optional alternative indoor test site using an anechoic chamber . 45
A.3.1 Example of the construction of a shielded anechoic chamber . 45
A.3.2 Influence of parasitic reflections in anechoic chambers . 45
A.3.3 Calibration of the shielded RF anechoic chamber . 46
Annex B (normative): Technical performance of the spectrum analyser . 48
Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to
405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 49
Annex D (informative): Bibliography . 50
History . 51
ETSI
6 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://webapp.etsi.org/IPR/home.asp).
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 (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM), and is now submitted for the Public Enquiry 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 Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering 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
ULP-AMI/ULP-AMI-P equipment in the MICS service is a unique new technology, available world wide in the
medical field, that will provide 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.
ETSI
7 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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 (normative) provides specifications for test equipment.
Annex C (informative) Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source ERM_TG30 see
URL: http://www.etsi.org).
Annex D (informative) bibliography; provides additional information.
ETSI
8 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
1 Scope
The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered
necessary to efficiently use the available spectrum and serve the interests of implant users. 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 (listen before talk protocol) designed to significantly reduce any interference
potential between MICS systems operating in the band or between a MICS system and the primary users of the band.
Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to
403,8 MHz frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC
(R&TTE Directive) [i.1].
It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and 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 ULP-AMI radio equipment which is also addressed by
CEPT/ERC/REC 70-03 [i.2] and annex 12 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 ULP-AMI devices and accessories operating in the 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;
- 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 25 MHz.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
For online referenced documents, information sufficient to identify and locate the source shall be provided. Preferably,
the primary source of the referenced document should be cited, in order to ensure traceability. Furthermore, the
reference should, as far as possible, remain valid for the expected life of the document. The reference shall include the
method of access to the referenced document and the full network address, with the same punctuation and use of upper
case and lower case letters.
NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee
their long term validity.
ETSI
9 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
2.1 Normative references
The following referenced documents are indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest edition of the referenced document
(including any amendments) applies.
[1] CISPR 16-2-3 (2003): "Specification for radio disturbance and immunity measuring apparatus and
methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance
measurements".
[2] ANSI C63.17 (1998): "American National Standard for Methods of Measurement of the
Electromagnetic and Operational Compatibility of Unlicensed Personal Communications Services
(PCS) Devices".
NOTE: See http://www.techstreet.com/cgi-bin/detail?product_id=43013.
[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".
2.2 Informative references
The following referenced documents are not essential to the use of the ETSI deliverable but they assist the user with
regard to a particular subject area. For non-specific references, the latest version of the referenced document (including
any amendments) applies.
[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 (02-2007): "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] ITU-R Recommendation 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.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] ERC/DEC(01)17: "ERC Decision of 12 March 2001 on harmonised frequencies, technical
characteristics and exemption from individual licensing of short Range Devices used for Ultra
Low Power Active Medical Implants operating in the frequency band 402 - 405 MHz".
[i.8] ETSI EN 301 839-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN
covering essential requirements of article 3.2 of the R&TTE Directive".
[i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by G.
Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36 (1987).
ETSI
10 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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 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
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 8.6.1.
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 8.3.1.
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 8.2.1.1 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 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 8.5.1.
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 shall select 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
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 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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
NOTE 1: As stated in CEPT/ERC/REC 70-03 [i.2], annex 12 Band a, it is permitted to aggregate 25 kHz segments
up to a maximum of 300 kHz for each channel bandwidth.
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 emissions: emissions at frequencies other than those of the carrier and sidebands associated with normal test
modulation
NOTE: See clause 8.4.1.
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
ETSI
12 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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): the 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
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 A)
f frequency
f channel centre frequency
c
f frequency under extreme conditions
e
G Antenna Gain
NaCl sodium chloride
P power
R distance
Ro Reference distance (see annex A)
P maximum threshold power level (see clause 10)
Th
t time
λ wavelength
3.3 Abbreviations
For the purposes of the present document, the
...
Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
European Standard (Telecommunications series)
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 1: Technical characteristics and test methods
2 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
Reference
REN/ERM-TG30-263-1
Keywords
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
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© European Telecommunications Standards Institute 2009.
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ETSI
3 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
4.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13
4.2.3.1 Equipment with an internal permanent or temporary antenna connector . 13
4.2.3.2 Equipment with a temporary antenna connector . 14
4.2.3.3 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 . 14
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 Regulated lead-acid battery power sources . 16
5.3.2.3 Other 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 . 18
5.4.2 Extreme test source voltages . 18
5.4.2.1 Mains voltage . 18
5.4.2.2 Regulated lead-acid battery power sources . 18
5.4.2.3 Power sources using other types of batteries . 18
5.4.2.4 Other power sources . 19
ETSI
4 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
6 General conditions . 19
6.1 Normal test signals and test modulation . 19
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 20
6.6 Test sites and general arrangements for radiated measurements . 20
6.7 Modes of operation of the transmitter . 21
6.8 Measuring receiver . 21
7 Measurement uncertainty . 22
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 23
8.1.1 Definition . 23
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 carrier frequency . 23
8.1.2 Limit . 24
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
8.2.2 Limits . 25
8.3 Effective radiated power of the fundamental emission . 25
8.3.1 Definition . 25
8.3.1.1 Methods of measurement . 25
8.3.2 Limits . 26
8.4 Spurious domain emissions . 26
8.4.1 Definition . 26
8.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26
8.4.2 Limits . 28
8.5 Frequency stability under low voltage conditions . 28
8.5.1 Definition . 28
8.5.1.1 Method of measurement . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious domain radiation . 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29
9.1.2 Limits . 31
10 Requirements and Measuring Methods for Monitoring Systems . 31
10A Purpose . 31
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 32
10.1.1 Measurement method using out-of-operating-region disturbance . 33
10.1.2 Measurement method using frequency administration commands . 33
10.1.3 Results based on above test method . 33
10.1.4 Limit . 34
10.2 Monitoring system bandwidth . 34
10.2.1 Measurement method using out-of-operating-region disturbance . 34
10.2.2 Measurement method using frequency administration commands . 35
10.2.3 Results based on above test method . 35
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.3.1 Measurement method using out-of-operating-region disturbance . 35
10.3.1.1 Scan cycle time . 35
10.3.1.2 Minimum channel monitoring period . 36
ETSI
5 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
10.3.2 Measurement method using frequency administration commands . 36
10.3.3 Results based on above test method . 36
10.3.3.1 Scan cycle time . 36
10.3.3.2 Minimum Channel Monitoring Period . 36
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 37
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 37
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.4.3 Results based on above test method . 38
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs . 38
10.5.1 Measurement method . 38
10.5.2 Results based on above test method . 38
10.6 Use of pre-scanned alternative channel . 38
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 39
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 40
10.6.3 Results based on above test method . 40
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 Human torso simulator for ULP-AMI . 42
A.1.2 Test antenna . 43
A.1.3 Substitution antenna . 43
A.1.4 Optional additional indoor site . 44
A.2 Guidance on the use of radiation test sites . 45
A.2.1 Measuring distance . 45
A.2.2 Test antenna . 45
A.2.3 Substitution antenna . 45
A.2.4 Artificial antenna . 45
A.2.5 Auxiliary cables . 45
A.3 Further optional alternative indoor test site using an anechoic chamber . 46
A.3.1 Example of the construction of a shielded anechoic chamber . 46
A.3.2 Influence of parasitic reflections in anechoic chambers . 46
A.3.3 Calibration of the shielded RF anechoic chamber . 47
Annex B (normative): Technical performance of the spectrum analyser . 49
Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to
405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 50
Annex D (informative): Bibliography . 51
History . 52
ETSI
6 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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://webapp.etsi.org/IPR/home.asp).
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 (Telecommunications series) 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 Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering 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
ULP-AMI/ULP-AMI-P equipment in the MICS service is a unique new technology, available world wide in the
medical field, that will provide 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.
ETSI
7 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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 (normative) provides specifications for test equipment.
Annex C (informative) provides Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source
ERM_TG30 see URL: http://www.etsi.org).
Annex D (informative) bibliography; provides additional information.
ETSI
8 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
1 Scope
The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered
necessary to efficiently use the available spectrum and serve the interests of implant users. 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 (listen before talk protocol) designed to significantly reduce any interference
potential between MICS systems operating in the band or between a MICS system and the primary users of the band.
Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to
403,8 MHz frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.10]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for 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 402 MHz to 405 MHz only and 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 ULP-AMI radio equipment which is also addressed by
CEPT/ERC/REC 70-03 [i.2] and annex 12 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 ULP-AMI devices and accessories operating in the 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;
• 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 25 MHz.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
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.
ETSI
9 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
2.1 Normative references
The following referenced documents are indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest edition of the referenced document
(including any amendments) applies.
[1] CISPR 16-2-3 (2003): "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".
2.2 Informative references
The following referenced documents are not essential to the use of the present document but they assist the user with
regard to a particular subject area. For non-specific references, the latest version of the referenced document (including
any amendments) applies.
[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 (02-2007): "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] ITU-R Recommendation 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.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 Domain".
[i.7] ERC/DEC(01)17: "ERC Decision of 12 March 2001 on harmonized frequencies, technical
characteristics and exemption from individual licensing of short Range Devices used for Ultra
Low Power Active Medical Implants operating in the frequency band 402 - 405 MHz".
[i.8] ETSI EN 301 839-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN
covering essential requirements of article 3.2 of the R&TTE Directive".
[i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by
G. Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36
(1987).
[i.10] 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).
ETSI
10 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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 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
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 8.6.1.
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 8.3.1.
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 8.2.1.1 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 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 8.5.1.
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
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 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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
NOTE 1: As stated in CEPT/ERC/REC 70-03 [i.2], annex 12 Band a, it is permitted to aggregate 25 kHz segments
up to a maximum of 300 kHz for each channel bandwidth.
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 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 will result in compromising the health and/or safety of the
patient
Ultra Low Power Active Medical Implant (ULP-AMI): the radio part of an AIMD
ETSI
12 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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 8.4.1.
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 A)
f frequency
f channel centre frequency
c
f frequency under extreme conditions
e
G Antenna Gain
NaCl sodium chloride
P power
R distance
Ro Reference distance (see annex A)
P maximum threshold power level (see clause 10)
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
NOTE: See definitions.
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
SRD Short Range Device
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral
VSWR Voltage Standing Wave Ratio
ETSI
13 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
4 Technical requirements and spec
...
European Standard (Telecommunications series)
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 1: Technical characteristics and test methods
2 ETSI EN 301 839-1 V1.3.1 (2009-10)
Reference
REN/ERM-TG30-263-1
Keywords
radio, SRD, testing
ETSI
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Copyright Notification
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The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2009.
All rights reserved.
TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being 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 301 839-1 V1.3.1 (2009-10)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
4.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13
4.2.3.1 Equipment with an internal permanent or temporary antenna connector . 13
4.2.3.2 Equipment with a temporary antenna connector . 14
4.2.3.3 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 . 14
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 Regulated lead-acid battery power sources . 16
5.3.2.3 Other 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 . 18
5.4.2 Extreme test source voltages . 18
5.4.2.1 Mains voltage . 18
5.4.2.2 Regulated lead-acid battery power sources . 18
5.4.2.3 Power sources using other types of batteries . 18
5.4.2.4 Other power sources . 19
ETSI
4 ETSI EN 301 839-1 V1.3.1 (2009-10)
6 General conditions . 19
6.1 Normal test signals and test modulation . 19
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 20
6.6 Test sites and general arrangements for radiated measurements . 20
6.7 Modes of operation of the transmitter . 21
6.8 Measuring receiver . 21
7 Measurement uncertainty . 22
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 23
8.1.1 Definition . 23
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 carrier frequency . 23
8.1.2 Limit . 24
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
8.2.2 Limits . 25
8.3 Effective radiated power of the fundamental emission . 25
8.3.1 Definition . 25
8.3.1.1 Methods of measurement . 25
8.3.2 Limits . 26
8.4 Spurious domain emissions . 26
8.4.1 Definition . 26
8.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26
8.4.2 Limits . 28
8.5 Frequency stability under low voltage conditions . 28
8.5.1 Definition . 28
8.5.1.1 Method of measurement . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious domain radiation . 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29
9.1.2 Limits . 31
10 Requirements and Measuring Methods for Monitoring Systems . 31
10A Purpose . 31
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 32
10.1.1 Measurement method using out-of-operating-region disturbance . 33
10.1.2 Measurement method using frequency administration commands . 33
10.1.3 Results based on above test method . 33
10.1.4 Limit . 34
10.2 Monitoring system bandwidth . 34
10.2.1 Measurement method using out-of-operating-region disturbance . 34
10.2.2 Measurement method using frequency administration commands . 35
10.2.3 Results based on above test method . 35
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.3.1 Measurement method using out-of-operating-region disturbance . 35
10.3.1.1 Scan cycle time . 35
10.3.1.2 Minimum channel monitoring period . 36
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5 ETSI EN 301 839-1 V1.3.1 (2009-10)
10.3.2 Measurement method using frequency administration commands . 36
10.3.3 Results based on above test method . 36
10.3.3.1 Scan cycle time . 36
10.3.3.2 Minimum Channel Monitoring Period . 36
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 37
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 37
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.4.3 Results based on above test method . 38
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs . 38
10.5.1 Measurement method . 38
10.5.2 Results based on above test method . 38
10.6 Use of pre-scanned alternative channel . 38
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 39
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 40
10.6.3 Results based on above test method . 40
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 Human torso simulator for ULP-AMI . 42
A.1.2 Test antenna . 43
A.1.3 Substitution antenna . 43
A.1.4 Optional additional indoor site . 44
A.2 Guidance on the use of radiation test sites . 45
A.2.1 Measuring distance . 45
A.2.2 Test antenna . 45
A.2.3 Substitution antenna . 45
A.2.4 Artificial antenna . 45
A.2.5 Auxiliary cables . 45
A.3 Further optional alternative indoor test site using an anechoic chamber . 46
A.3.1 Example of the construction of a shielded anechoic chamber . 46
A.3.2 Influence of parasitic reflections in anechoic chambers . 46
A.3.3 Calibration of the shielded RF anechoic chamber . 47
Annex B (normative): Technical performance of the spectrum analyser . 49
Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to
405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 50
Annex D (informative): Bibliography . 51
History . 52
ETSI
6 ETSI EN 301 839-1 V1.3.1 (2009-10)
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://webapp.etsi.org/IPR/home.asp).
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 (Telecommunications series) 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 Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates
Date of adoption of this EN: 28 September 2009
Date of latest announcement of this EN (doa): 31 December 2009
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2010
Date of withdrawal of any conflicting National Standard (dow): 30 June 2010
Introduction
ULP-AMI/ULP-AMI-P equipment in the MICS service is a unique new technology, available world wide in the
medical field, that will provide 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.
ETSI
7 ETSI EN 301 839-1 V1.3.1 (2009-10)
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 (normative) provides specifications for test equipment.
Annex C (informative) provides Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source
ERM_TG30 see URL: http://www.etsi.org).
Annex D (informative) bibliography; provides additional information.
ETSI
8 ETSI EN 301 839-1 V1.3.1 (2009-10)
1 Scope
The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered
necessary to efficiently use the available spectrum and serve the interests of implant users. 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 (listen before talk protocol) designed to significantly reduce any interference
potential between MICS systems operating in the band or between a MICS system and the primary users of the band.
Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to
403,8 MHz frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.10]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for 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 402 MHz to 405 MHz only and 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 ULP-AMI radio equipment which is also addressed by
CEPT/ERC/REC 70-03 [i.2] and annex 12 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 ULP-AMI devices and accessories operating in the 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;
• 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 25 MHz.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
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.
ETSI
9 ETSI EN 301 839-1 V1.3.1 (2009-10)
2.1 Normative references
The following referenced documents are indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest edition of the referenced document
(including any amendments) applies.
[1] CISPR 16-2-3 (2003): "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".
2.2 Informative references
The following referenced documents are not essential to the use of the present document but they assist the user with
regard to a particular subject area. For non-specific references, the latest version of the referenced document (including
any amendments) applies.
[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 (02-2007): "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] ITU-R Recommendation 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.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 Domain".
[i.7] ERC/DEC(01)17: "ERC Decision of 12 March 2001 on harmonized frequencies, technical
characteristics and exemption from individual licensing of short Range Devices used for Ultra
Low Power Active Medical Implants operating in the frequency band 402 - 405 MHz".
[i.8] ETSI EN 301 839-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN
covering essential requirements of article 3.2 of the R&TTE Directive".
[i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by
G. Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36
(1987).
[i.10] 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).
ETSI
10 ETSI EN 301 839-1 V1.3.1 (2009-10)
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 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
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 8.6.1.
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 8.3.1.
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 8.2.1.1 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 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 8.5.1.
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
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 301 839-1 V1.3.1 (2009-10)
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
NOTE 1: As stated in CEPT/ERC/REC 70-03 [i.2], annex 12 Band a, it is permitted to aggregate 25 kHz segments
up to a maximum of 300 kHz for each channel bandwidth.
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 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 will result in compromising the health and/or safety of the
patient
Ultra Low Power Active Medical Implant (ULP-AMI): the radio part of an AIMD
ETSI
12 ETSI EN 301 839-1 V1.3.1 (2009-10)
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 8.4.1.
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 A)
f frequency
f channel centre frequency
c
f frequency under extreme conditions
e
G Antenna Gain
NaCl sodium chloride
P power
R distance
Ro Reference distance (see annex A)
P maximum threshold power level (see clause 10)
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
NOTE: See definitions.
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
SRD Short Range Device
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral
VSWR Voltage Standing Wave Ratio
ETSI
13 ETSI EN 301 839-1 V1.3.1 (2009-10)
4 Technical requirements and specifications
4.1 General requirements
4.1.1 Transmitter requirements
See clause 8 for transmitter requirements.
4.1.2 Receiver requirements
See clause 9.
4.2 Presentation of equipment for testing purposes
Each equipment submitted fo
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.PHWRGHElectromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 301 839-1 Version 1.3.1SIST EN 301 839-1 V1.3.1:2009en01-december-2009SIST EN 301 839-1 V1.3.1:2009SLOVENSKI
STANDARD
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 2
Reference REN/ERM-TG30-263-1 Keywords 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
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© European Telecommunications Standards Institute 2009. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. LTE™ is a Trade Mark of ETSI currently being 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 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Introduction . 6 1 Scope . 8 2 References . 8 2.1 Normative references . 9 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 10 3.1 Definitions . 10 3.2 Symbols . 12 3.3 Abbreviations . 12 4 Technical requirements and specifications . 13 4.1 General requirements . 13 4.1.1 Transmitter requirements . 13 4.1.2 Receiver requirements . 13 4.2 Presentation of equipment for testing purposes . 13 4.2.1 Choice of model for testing . 13 4.2.2 Testing of equipment with alternative power levels . 13 4.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 13 4.2.3.1 Equipment with an internal permanent or temporary antenna connector . 13 4.2.3.2 Equipment with a temporary antenna connector . 14 4.2.3.3 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 . 14 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 Regulated lead-acid battery power sources . 16 5.3.2.3 Other 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 . 18 5.4.2 Extreme test source voltages . 18 5.4.2.1 Mains voltage . 18 5.4.2.2 Regulated lead-acid battery power sources . 18 5.4.2.3 Power sources using other types of batteries . 18 5.4.2.4 Other power sources . 19 SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 4 6 General conditions . 19 6.1 Normal test signals and test modulation . 19 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 . 20 6.4 Test fixture for ULP-AMI-P . 20 6.5 Test fixture for ULP-AMI . 20 6.6 Test sites and general arrangements for radiated measurements . 20 6.7 Modes of operation of the transmitter . 21 6.8 Measuring receiver . 21 7 Measurement uncertainty . 22 8 Methods of measurement and limits for transmitter parameters . 22 8.1 Frequency error . 23 8.1.1 Definition . 23 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 carrier frequency . 23 8.1.2 Limit . 24 8.2 Emission bandwidth measurement . 24 8.2.1 Definition . 24 8.2.1.1 Method of measurement . 24 8.2.2 Limits . 25 8.3 Effective radiated power of the fundamental emission . 25 8.3.1 Definition . 25 8.3.1.1 Methods of measurement . 25 8.3.2 Limits . 26 8.4 Spurious domain emissions . 26 8.4.1 Definition . 26 8.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26 8.4.2 Limits . 28 8.5 Frequency stability under low voltage conditions . 28 8.5.1 Definition . 28 8.5.1.1 Method of measurement . 28 8.5.2 Limits . 28 8.6 ULP-AMI with restricted power and duty cycle . 28 8.6.1 Definitions . 28 8.6.2 Declaration of Duty Cycle . 28 8.6.3 Limit for duty cycle and maximum number of transmissions . 29 9 Methods of measurement and limits for receiver parameters . 29 9.1 Spurious domain radiation . 29 9.1.1 Definition . 29 9.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29 9.1.2 Limits . 31 10 Requirements and Measuring Methods for Monitoring Systems . 31 10A Purpose . 31 10B General Remarks on the Measurement Configuration . 31 10.1 LBT threshold power level . 32 10.1.1 Measurement method using out-of-operating-region disturbance . 33 10.1.2 Measurement method using frequency administration commands . 33 10.1.3 Results based on above test method . 33 10.1.4 Limit . 34 10.2 Monitoring system bandwidth . 34 10.2.1 Measurement method using out-of-operating-region disturbance . 34 10.2.2 Measurement method using frequency administration commands . 35 10.2.3 Results based on above test method . 35 10.3 Monitoring system scan cycle time and minimum channel monitoring period . 35 10.3.1 Measurement method using out-of-operating-region disturbance . 35 10.3.1.1 Scan cycle time . 35 10.3.1.2 Minimum channel monitoring period . 36 SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 5 10.3.2 Measurement method using frequency administration commands . 36 10.3.3 Results based on above test method . 36 10.3.3.1 Scan cycle time . 36 10.3.3.2 Minimum Channel Monitoring Period . 36 10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 37 10.4.1 Access based on lowest ambient level above PTh using out-of-operating-region disturbance . 37 10.4.2 Access based on lowest ambient level above PTh using frequency administration commands . 37 10.4.3 Results based on above test method . 38 10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs . 38 10.5.1 Measurement method . 38 10.5.2 Results based on above test method . 38 10.6 Use of pre-scanned alternative channel . 38 10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 39 10.6.2 Measurement method for alternate channel selection using frequency administration commands . 40 10.6.3 Results based on above test method . 40 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 Human torso simulator for ULP-AMI . 42 A.1.2 Test antenna . 43 A.1.3 Substitution antenna . 43 A.1.4 Optional additional indoor site . 44 A.2 Guidance on the use of radiation test sites . 45 A.2.1 Measuring distance . 45 A.2.2 Test antenna . 45 A.2.3 Substitution antenna . 45 A.2.4 Artificial antenna . 45 A.2.5 Auxiliary cables . 45 A.3 Further optional alternative indoor test site using an anechoic chamber . 46 A.3.1 Example of the construction of a shielded anechoic chamber . 46 A.3.2 Influence of parasitic reflections in anechoic chambers . 46 A.3.3 Calibration of the shielded RF anechoic chamber . 47 Annex B (normative): Technical performance of the spectrum analyser . 49 Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 50 Annex D (informative): Bibliography . 51 History . 52
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 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://webapp.etsi.org/IPR/home.asp). 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 (Telecommunications series) 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 Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz, as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 28 September 2009 Date of latest announcement of this EN (doa): 31 December 2009 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 June 2010 Date of withdrawal of any conflicting National Standard (dow): 30 June 2010
Introduction ULP-AMI/ULP-AMI-P equipment in the MICS service is a unique new technology, available world wide in the medical field, that will provide 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. SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 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 (normative) provides specifications for test equipment. Annex C (informative) provides Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source ERM_TG30 see URL: http://www.etsi.org). Annex D (informative) bibliography; provides additional information. SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 8 1 Scope The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of implant users. 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 (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to 403,8 MHz frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.10]: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for 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 402 MHz to 405 MHz only and 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 ULP-AMI radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 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 ULP-AMI devices and accessories operating in the 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; • 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 25 MHz. 2 References References are either specific (identified by date of publication and/or edition number or version number) or non-specific. • For a specific reference, subsequent revisions do not apply. • Non-specific reference may be made only to a complete document or a part thereof and only in the following cases: - if it is accepted that it will be possible to use all future changes of the referenced document for the purposes of the referring document; - for informative references. 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. SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 9 2.1 Normative references The following referenced documents are indispensable for the application of the present document. For dated references, only the edition cited applies. For non-specific references, the latest edition of the referenced document (including any amendments) applies. [1] CISPR 16-2-3 (2003): "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". 2.2 Informative references The following referenced documents are not essential to the use of the present document but they assist the user with regard to a particular subject area. For non-specific references, the latest version of the referenced document (including any amendments) applies. [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 (02-2007): "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] ITU-R Recommendation 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.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 Domain". [i.7] ERC/DEC(01)17: "ERC Decision of 12 March 2001 on harmonized frequencies, technical characteristics and exemption from individual licensing of short Range Devices used for Ultra Low Power Active Medical Implants operating in the frequency band 402 - 405 MHz". [i.8] ETSI EN 301 839-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive". [i.9] "Simulated Biological Materials for Electromagnetic Radiation Absorption Studies", by G. Hartsgrove, A. Kraszewski, and A. Surowiec as published in Bioelectromagnetics 8:29-36 (1987). [i.10] 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). SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 10 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 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 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 8.6.1. 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 8.3.1. 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 8.2.1.1 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 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 8.5.1. 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 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 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 11 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 NOTE 1: As stated in CEPT/ERC/REC 70-03 [i.2], annex 12 Band a, it is permitted to aggregate 25 kHz segments up to a maximum of 300 kHz for each channel bandwidth. 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 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 will result in compromising the health and/or safety of the patient Ultra Low Power Active Medical Implant (ULP-AMI): the radio part of an AIMD SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 12 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 8.4.1. 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 A) f frequency fc channel centre frequency fe frequency under extreme conditions G Antenna Gain NaCl sodium chloride P power R distance Ro Reference distance (see annex A) PTh maximum threshold power level (see clause 10) 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 NOTE: See definitions. 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 SRD Short Range Device ULP-AMI Ultra Low Power Active Medical Implant ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral VSWR Voltage Standing Wave Ratio SIST EN 301 839-1 V1.3.1:2009
ETSI ETSI EN 301 839-1 V1.3.1 (2009-10) 13 4 Technical requirements and specifications 4.1 General requirements 4.1.1 Transmitter requirements See clause 8 for transmitter requirements. 4.1.2 Receiver requirements See clause 9. 4.2 Presentation of equipment for t
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