SIST EN 302 537-1 V1.1.2:2008

European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Medical Data Service Systems
operating in the frequency range
401 MHz to 402 MHz and 405 MHz to 406 MHz;
Part 1: Technical characteristics and
test methods
2 ETSI EN 302 537-1 V1.1.2 (2007-12)

Reference
DEN/ERM-TG30-005-1
Keywords
health, SRD
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3 ETSI EN 302 537-1 V1.1.2 (2007-12)
Contents
Intellectual Property Rights.6
Foreword.6
Introduction .7
1 Scope.8
2 References.9
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.13
4 Technical requirements and specifications.13
4.1 General requirements.13
4.1.1 Transmitter requirements.13
4.1.2 Receiver requirements.13
4.1.3 Spectrum access requirements .13
4.2 Presentation of equipment for testing purposes.13
4.2.1 Choice of model for testing .14
4.2.2 Testing of equipment with alternative power levels .14
4.2.3 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) .14
4.2.3.1 Equipment with an internal permanent or temporary antenna connector.14
4.2.3.2 Equipment with a temporary antenna connector.14
4.2.3.3 Equipment intended to be implanted in or worn on but totally external to a human body.15
4.3 Mechanical and electrical design.15
4.3.1 General.15
4.3.2 Controls.15
4.3.3 Transmitter shut-off facility.15
4.3.4 Marking.15
4.3.5 Equipment identification.15
4.4 Declarations by the provider .15
4.5 Auxiliary test equipment .15
4.6 Interpretation of the measurement results .16
5 Test conditions, power sources and ambient temperatures .16
5.1 Normal and extreme test conditions .16
5.2 Test power source.16
5.2.1 External test power source.16
5.2.2 Internal test power source .17
5.3 Normal test conditions.17
5.3.1 Normal temperature and humidity.17
5.3.2 Normal test power source .17
5.3.2.1 Mains voltage.17
5.3.2.2 Regulated lead-acid battery power sources .17
5.3.2.3 Other power sources.17
5.4 Extreme test conditions .18
5.4.1 Extreme temperatures.18
5.4.1.1 Procedure for tests at extreme temperatures.18
5.4.1.1.1 Procedure for equipment designed for continuous operation .18
5.4.1.1.2 Procedure for equipment designed for intermittent operation .18
5.4.1.2 Extreme temperature ranges.19
5.4.2 Extreme test source voltages.19
5.4.2.1 Mains voltage.19
5.4.2.2 Regulated lead-acid battery power sources .19
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4 ETSI EN 302 537-1 V1.1.2 (2007-12)
5.4.2.3 Power sources using other types of batteries.19
5.4.2.4 Other power sources.20
6 General conditions.20
6.1 Normal test signals and test modulation.20
6.1.1 Normal modulation test signals for data .20
6.2 Antennas.20
6.3 Artificial antenna.20
6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector.20
6.4 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices .21
6.5 Test fixture for ULP-AMI and ULP-BWD .21
6.6 Test sites and general arrangements for radiated measurements .21
6.7 Modes of operation of the transmitter .22
6.8 Measuring receiver.22
7 Measurement uncertainty .22
8 Methods of measurement and limits for transmitter parameters .23
8.1 Frequency error.23
8.1.1 Definition.24
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency provision.24
8.1.1.2 Method of measurement for systems with a modulated carrier frequency.24
8.1.2 Limit.24
8.2 Emission bandwidth measurement.25
8.2.1 Definition.25
8.2.1.1 Method of measurement.25
8.2.2 Limits.25
8.3 Effective radiated power of the fundamental emission .25
8.3.1 Definition.26
8.3.1.1 Methods of measurement.26
8.3.2 Limit as a function of spectrum access method .26
8.3.2.1 Limit for systems using LBT and AFA for spectrum access .27
8.3.2.2 Limit for devices using low duty cycle and low power for spectrum access .27
8.4 Spurious emissions.27
8.4.1 Definition.27
8.4.1.1 Method of measuring the effective radiated power of spurious emissions.27
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.29
8.6 Spectrum access based on low power and low duty cycle .29
8.6.1 Definition.29
8.6.1.1 Methods of measurement.29
8.6.2 Limits.30
8.6.2.1 Duty cycle limit.30
8.6.2.2 Repetitive transmission within an hour.30
9 Methods of measurement and limits for receiver parameters.30
9.1 Spurious radiation.30
9.1.1 Definition.31
9.1.1.1 Method of measuring the effective radiated power of spurious radiations.31
9.1.2 Limits.31
10 Requirements for spectrum access and measuring methods for monitoring systems using LBT and
AFA.32
10.1 Purpose.32
10.2 LBT threshold power level.32
10.2.1 Measurement method using out-of-operating-region interference.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 bandwidth.34
10.3.1 Measurement method using out-of-operating-region interference.34
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5 ETSI EN 302 537-1 V1.1.2 (2007-12)
10.3.2 Measurement method using frequency administration commands .35
10.3.3 Results based on above test method.35
10.4 Monitoring system scan cycle time and minimum channel monitoring period.35
10.4.1 Measurement method using out-of-operating-region interference.35
10.4.1.1 Scan cycle time .35
10.4.1.2 Minimum channel monitoring period .36
10.4.2 Measurement method using frequency administration commands .36
10.4.3 Results based on above test method.36
10.4.3.1 Scan cycle time .36
10.4.3.2 Minimum Channel Monitoring Period.37
10.5 Channel access based on ambient levels relative to the calculated access LBT threshold level, P .37
Th
10.5.1 Access based on lowest ambient level above P using out-of-operating-region interference.37
Th
10.5.2 Access based on lowest ambient level above P using frequency administration commands .38
Th
10.5.3 Results based on above test method.38
10.6 Discontinuation of MEDS session if a silent period greater than or equal to 5 s occurs .38
10.6.1 Measurement method.38
10.6.2 Results based on above test method.38
10.7 Use of pre-scanned alternate channel .39
10.7.1 Measurement method for alternate channel selection using out-of-operating-region interference.39
10.7.2 Measurement method for alternate channel selection using frequency administration commands .40
10.7.3 Results based on above test method.40
Annex A (normative): Radiated measurements .42
A.1 Test sites and general arrangements for measurements involving the use of radiated fields .42
A.1.1 Outdoor test site .42
A.1.1.1 Standard position.43
A.1.1.2 Equipment in close proximity to the human body but external to it .43
A.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI.43
A.1.2 Test antenna.44
A.1.3 Substitution antenna.44
A.1.4 Optional additional indoor site .45
A.2 Guidance on the use of radiation test sites .45
A.2.1 Measuring distance.46
A.2.2 Test antenna.46
A.2.3 Substitution antenna.46
A.2.4 Artificial antenna.46
A.2.5 Auxiliary cables.46
A.3 Further optional alternative indoor test site using a fully anechoic chamber.46
A.3.1 Example of the construction of a fully anechoic chamber.47
A.3.2 Influence of parasitic reflections in fully anechoic chambers .47
A.3.3 Calibration of the fully anechoic chamber .47
Annex B (normative): Technical performance of the spectrum analyser.50
Annex C (informative): Bibliography.51
History .52

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6 ETSI EN 302 537-1 V1.1.2 (2007-12)
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 radio equipment in the frequency range
401 MHz to 402 MHz and 405 MHz to 406 MHz for Ultra Low Power Active Medical Devices and implants. This
includes Body Worn, Hand-Held, Data systems, etc., the medical section of which is regulated under the Medical
Device Directive [10] and Active Medical Implants and Peripherals the medical section of which is regulated under the
Active Implantable Medical Device Directive [11] and the radio part of which are regulated under the R&TTE
Directive [8], 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: 14 December 2007
Date of latest announcement of this EN (doa): 31 March 2008
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 September 2008
Date of withdrawal of any conflicting National Standard (dow): 30 September 2008

ETSI
7 ETSI EN 302 537-1 V1.1.2 (2007-12)
Introduction
The present document covers the ultra low power radio transmitters used in a new Medical Data Service and the various
types of devices that form part of the system providing the service. It includes methods of measurement and
requirements for radio systems used in the service that are fitted with an antenna connector and/or having an integral
antenna. If a device which is operating in the MEDS and 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 and abbreviations used.
• Clause 4 provides a guide to essential 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 the spectrum utilization parameters. Clause 8 specifies low power low duty cycle
spectrum access technical parameters. Clause 9 specifies receiver technical requirements. Clause 10 specifies
methods of spectrum access that are required to be implemented in order to gain access to the available
spectrum. In particular clause 10.2 and subsequent clauses describe specifications that have been chosen to
minimize harmful interference to other equipment or services and reduce the potential for interference to this
equipment from ambient sources based on use of LBT and AFA.
• Annex A (normative) provides specifications concerning radiated measurements.
• Annex B (normative) provides specifications for test equipment.
• Annex C (informative) bibliography; provides additional information.
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8 ETSI EN 302 537-1 V1.1.2 (2007-12)
1 Scope
The present document covers various individual devices which when operating together form a system operating as a
Medical Data Service (MEDS) that provides medical practitioners with therapeutic and/or diagnostic information used
to provide improved medical treatment of a patient and/or to provide an interactive system for patient control of
therapeutic devices. MEDS is intended only for transmission of non-time critical data, the loss of which will not
compromise the health and/or safety of the patient.
Devices covered by the present document are an evolving new technology to be made available worldwide by the
medical equipment industry that will provide high speed communications capability between devices associated with an
individual patient that are part of a complete MEDS system as defined in clause 3.1. Examples of MEDS devices falling
under the scope of the present document are portable body worn physiological sensors that allow ambulatory
monitoring, implanted devices and external system devices used to transfer data collected by a MEDS system to
medical practitioners who will use the data to diagnose and/or treat a patient.
These devices utilize ultra low power radio transmitters in combination with medical devices, the medical portion of
which is regulated by the Medical Device Directive (MDD) [10] or the Active Implantable Medical Device Directive
(AIMD) [11]. The radio part of medical devices regulated by the MDD is hereafter referred to as ULP-AMD,
ULP-AMD-P for peripheral devices, and ULP-BWD for body worn devices. ULP-BWD are devices, such as a
physiological parameter sensors or handheld devices that are intended to operate in very close proximity to the human
body, including touching the body, the radio antenna of which is external to the body and is used to communicate with a
device that is part of a MEDS system. The radio part of medical devices regulated under the AIMD is hereafter referred
to as Ultra Low Power-Active Medical Implants (ULP-AMI) and peripherals (ULP-AMI-P) used in a Medical Data
Service (MEDS).
The present document contains required characteristics considered necessary for the radio sections to meet in order to
efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and delivering
therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum monitoring and
access requirements (listen before talk protocol) designed to significantly reduce any interference potential between
MEDS systems operating in the band or between a MEDS system and the primary users of the band.
The present document is a specific product standard applicable to ultra low power transmitters that are part of a system
used in the MEDS operating in spectrum within the frequency bands 401 MHz to 402 MHz and 405 MHz to 406 MHz.
The present document contains the technical characteristics for ultra low power radio equipment and is addressed by
CEPT/ERC/REC 70-03 [9] 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 ultra low power systems and accessories operating in spectrum within the bands 401 MHz to 402 MHz and
405 MHz to 406 MHz that operate in the MEDS service:
• for telecommand and telemetry between any devices that are part of a MEDS (see definition of MEDS);
• with or without an integral antenna; and/or;
• with an antenna connection provided only for the purpose of connecting an external dedicated antenna.
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9 ETSI EN 302 537-1 V1.1.2 (2007-12)
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.
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] ETSI TR 100 028 (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[2] ITU-T Recommendation O.153 (1992): "Basic parameters for the measurement of error
performance at bit rates below the primary rate".
[3] 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".
[4] "Radiofrequency Radiation Dosimetry Handbook" (October 1986), USAF School of Aerospace
Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301.
[5] ANSI C63.17 (1998): "American National Standard for Methods of Measurement of the
Electromagnetic and Operational Compatibility of Unlicensed Personal Communications Services
(UPCS) Devices".
2.2 Informative references
[6] ETSI EN 302 537-2: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Short
Range Devices (SRD); Ultra Low Power Medical Data Service systems operating in the frequency
range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential
requirements of article 3.2 of the R&TTE Directive".
[7] G. Hartsgrove, A. Kraszewski, and A. Surowiec: "Simulated Biological Materials for
Electromagnetic Radiation Absorption Studies", as published in Bioelectromagnetics 8:29-36
(1987).
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10 ETSI EN 302 537-1 V1.1.2 (2007-12)
[8] 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).
[9] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[10] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MD Directive).
[11] 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).
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the following terms and definitions apply:
access protocol: specification for measuring natural and man-made ambient background levels for the purpose of
providing a technique for spectrum access that reduces the potential for harmful interference to/from other users of the
spectrum
Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any
source of power other than that directly generated by the human body or gravity
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
minimize interference with other users of the same band
artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the provider
Body Worn Device (BWD): a medical sensor, handheld device, or other medical device intended to be operated in
close proximity to the human body, and is used to sense and/or transfer, via means of radio frequency transmission,
human physiological parameters or system programming information
conducted measurements: measurements that are made using a direct 50 Ω 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
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: Compliance is determined using instrumentation employing a peak detector function and a resolution
bandwidth approximately equal to 1 % of the emission bandwidth of the device under test.
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 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
interference to or receiving interference from other users of the band
Listen Before Talk (LBT): combination of the listen mode followed by the talk mode
listen mode: action taken by an interrogator to detect an unoccupied sub-band or channel
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11 ETSI EN 302 537-1 V1.1.2 (2007-12)
Medical Data Service (MEDS): service that uses a system specifically for the purpose of providing non-voice digital
communications between active medical implants and/or body worn devices and other devices external to the human
body engaged in transferring non-time critical individual patient related physiological information
Medical Data Service (MEDS) communication session: collection of transmissions that may or may not be
continuous, between co-operating ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P
Medical Data Service (MEDS) system: collection of medical devices having short range RF transmitting capability,
that are associated with a specific patient, consisting of at least one active medical implant or body worn device together
with other devices external to the body, that have the ability to communicate with each other using frequencies in the
401 MHz to 402 MHz and/or 405 MHz to 406 MHz bands
Medical Data Service (MEDS) System Communication Link (MEDSCL): collection of transmissions that may or
may not be continuous, between MEDS system devices including at least one active medical implant or body worn
device together with other devices external to the body engaged in transferring non-time critical patient related
physiological information collected by a single MEDS system
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 provider 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 Data Service (MEDS) System 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 MEDS session
NOTE: As stated in CEPT/ERC/REC 70-03 [9], annex 12 Bands a1 and a2, it is permitted to aggregate 25 kHz
segments up to a maximum of 100 kHz for each channel bandwidth.
Medical Data Service (MEDS) System Device: Any ultra low power medical device transmitting in the 401 MHz to
402 MHz and/or 405 MHz to 406 MHz band. Only two types of MEDS system devices are permitted under the present
document:
1) Frequency agile devices designed to access a minimum of 18 channels evenly distributed across the 401 MHz
to 402 MHz and 405 MHz to 406 MHz bands with a minimum of 9 channels defined for each 1 MHz segment
(i.e. 401 MHz to 402 MHz and 405 MHz to 406 MHz).
2) Devices capable of operation only on a single channel using low duty cycle and low power for spectrum access
in the 401 MHz to 402 MHz or 405 MHz to 406 MHz bands, see clause 8.6 and the following clauses.
monitoring system: circuitry in an active medical device that assures conformity with the spectrum access protocol
requirements based on Listen before Talk for channel selection and Adaptive Frequency Agility to access the channel
selected by the LBT process for operation
provider: manufacturer or person responsible for placing the apparatus on the market
NOTE: See R&TTE Directive [8], article 6.3.
radiated measurements: measurements which involve the absolute measurement of a radiated field
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
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12 ETSI EN 302 537-1 V1.1.2 (2007-12)
Ultra Low Power Active Medical Implant (ULP-AMI): the radio part of 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
NOTE: The medical function of such device is regulated under the AIM
...