ETSI EN 302 537-1 V1.1.2 (2007-12)

ETSI EN 302 537-1 V1.1.2 (2007-12)
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

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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
ETSI

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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

ETSI

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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

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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)
...