SIST EN 302 537-1 V1.1.2:2008

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

Develop a product standard for Ultra Low Power Active Medical Implants ( ULP-AMI) operating in the frequency range of 401-402MHz & 405-406 MHz.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.

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Naprave kratkega dosega (SRD) - Službeni sistemi ultra majhnih moči za medicinske podatke, ki delujejo v frekvenčnih območjih od 401 MHz do 402 MHz in od 405 MHz do 406 MHz - 1. del: Tehnične karakteristike in preskusne metode

General Information

• Status: Published
• Publication Date: 15-Jul-2008
• ICS: 33.060.99 - Other equipment for radiocommunications
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: MOC - Mobile Communications
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 10-Jun-2008
• Due Date: 15-Aug-2008
• Completion Date: 16-Jul-2008
• Ref Project: ETSI EN 302 537-1 V1.1.2 (2007-12) - 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

Standards Content (Sample)

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

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



Reference
DEN/ERM-TG30-005-1
Keywords
health, SRD
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: [phone]  Fax: [phone]

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

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

© European Telecommunications Standards Institute 2007.
All rights reserved.

TM TM TM
DECT , PLUGTESTS and UMTS are Trade Marks of ETSI registered for the benefit of its Members.
TM
TIPHON and the TIPHON logo are Trade Marks currently being registered by ETSI 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.
ETSI

---------------------- Page: 2 ----------------------
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

---------------------- Page: 3 ----------------------
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
ETSI

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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

---------------------- Page: 6 ----------------------
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)
...

SLOVENSKI STANDARD
SIST EN 302 537-1 V1.1.2:2008
01-september-2008
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1DSUDYHNUDWNHJDGRVHJD65'6OXåEHQLVLVWHPLXOWUDPDMKQLKPRþL]D
PHGLFLQVNHSRGDWNHNLGHOXMHMRYIUHNYHQþQLKREPRþMLKRG0+]GR0+]LQ
RG0+]GR0+]GHO7HKQLþQHNDUDNWHULVWLNHLQSUHVNXVQHPHWRGH
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
Ta slovenski standard je istoveten z: EN 302 537-1 Version 1.1.2
ICS:
33.060.99 Druga oprema za radijske Other equipment for
komunikacije radiocommunications
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN 302 537-1 V1.1.2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 302 537-1 V1.1.2:2008

---------------------- Page: 2 ----------------------

SIST EN 302 537-1 V1.1.2:2008

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

---------------------- Page: 3 ----------------------

SIST EN 302 537-1 V1.1.2:2008
 2 ETSI EN 302 537-1 V1.1.2 (2007-12)



Reference
DEN/ERM-TG30-005-1
Keywords
health, SRD
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: [phone]  Fax: [phone]

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

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

© European Telecommunications Standards Institute 2007.
All rights reserved.

TM TM TM
DECT , PLUGTESTS and UMTS are Trade Marks of ETSI registered for the benefit of its Members.
TM
TIPHON and the TIPHON logo are Trade Marks currently being registered by ETSI 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.
ETSI

---------------------- Page: 4 ----------------------

SIST EN 302 537-1 V1.1.2:2008
 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

---------------------- Page: 5 ----------------------

SIST EN 302 537-1 V1.1.2:2008
 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
ETSI

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SIST EN 302 537-1 V1.1.2:2008
 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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SIST EN 302 537-1 V1.1.2:2008
 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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SIST EN 302 537-1 V1.1.2:2008
 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 an
...