SIST EN 302 537-2 V1.1.2:2008

• Abstract:

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

• 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
• Directive: 1999/5/EC - 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
• Directive:

  ---

  TRRTP123 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-3)
• Mandate: M/284
• Ref Project: ETSI EN 302 537-2 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 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Overview

SIST EN 302 537-2 V1.1.2:2008 is a harmonized European standard developed by SIST, based on ETSI EN 302 537-2, focusing on electromagnetic compatibility (EMC) and radio spectrum management for ultra low power medical data service systems. Specifically, it addresses Short Range Devices (SRD) such as Ultra Low Power Active Medical Implants (ULP-AMI) operating in the 401-402 MHz and 405-406 MHz frequency bands. This standard sets out the essential radio requirements under Article 3.2 of the R&TTE Directive, facilitating the safe, reliable, and standardized operation of medical devices communicating via wireless technologies.

Key Topics

• Scope: Covers radio sections of medical data services (MEDS) involving body-worn, handheld, implantable, and peripheral medical devices using ultra low power radio transmitters.
• Frequency Bands: Applies to equipment operating specifically within 401-402 MHz and 405-406 MHz.
• Essential Requirements:
  • Mechanical and electrical design to minimize harmful interference.
  • Frequency error, emission bandwidth, effective radiated power, and spurious emissions requirements.
  • Frequency stability under low voltage conditions.
  • Spurious radiation limits for receivers.
  • Spectrum access protocols such as Listen Before Talk (LBT), Adaptive Frequency Agility (AFA), and low power/low duty cycle methods.
• Testing and Compliance:
  • Sets out necessary test suites for conformance.
  • Measurement uncertainties must be within accredited thresholds.
  • Test conditions must match device operational environments as declared by the manufacturer.
• Regulatory Alignment: Complies with the essential requirements of the R&TTE Directive, as well as Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD).

Applications

SIST EN 302 537-2 V1.1.2:2008 supports a wide range of applications in the medical device and health technology sectors, particularly where reliable wireless communication is critical:

• Ultra Low Power Active Medical Implants (ULP-AMI): Includes pacemakers, neurostimulators, and other long-term implants requiring secure, interference-minimized communications.
• Body-Worn and Handheld Medical Devices: Enables ambulatory monitoring through physiological sensors and portable monitoring systems for diagnostics and therapy.
• Medical Data Service Systems (MEDS): Standardizes communication protocols for telecommand and telemetry between interconnected devices (implanted and external) associated with a patient.
• Healthcare Infrastructure: Ensures hospital and clinic wireless environments support coexistence and minimal interference, contributing to patient safety.
• Medical Industry Compliance: Facilitates device certification for European markets, helping manufacturers demonstrate conformity and market readiness.

Related Standards

• EN 302 537-1
  • Part 1 of this series, detailing detailed technical characteristics and test methods for ultra low power medical data service systems.
• ETSI TR 100 028
  • Provides guidance on measurement uncertainties in mobile radio equipment.
• Medical Device Directive (93/42/EEC)
  • Establishes general requirements for medical device safety and performance.
• Active Implantable Medical Device Directive (90/385/EEC)
  • Specifies requirements for permanently implanted active medical devices.
• CEPT/ERC/REC 70-03
  • Recommends guidelines for SRD use within Europe.
• R&TTE Directive (1999/5/EC)
  • Defines the essential requirements and assessment procedures for radio and telecommunications terminal equipment in the European Union.

By following SIST EN 302 537-2 V1.1.2:2008, manufacturers, healthcare providers, and regulatory organizations ensure the effective deployment of ultra low power medical wireless devices with reliable interoperability, electromagnetic compatibility, and alignment with European EMC and radio regulations. This standard underpins innovation in medical wireless telemetry, boosting patient care and safety with robust technical foundations.

Harmonized 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 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

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

Reference
DEN/ERM-TG30-005-2
Keywords
health, regulation, 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 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.
ETSI
3 ETSI EN 302 537-2 V1.1.2 (2007-12)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.7
2.1 Normative references.7
2.2 Informative references.7
3 Definitions and abbreviations.8
3.1 Definitions.8
3.2 Abbreviations.8
4 Technical requirements and specifications.8
4.1 Environmental profile.8
4.2 Conformance requirements.8
4.2.1 Mechanical and electrical design .8
4.2.1.1 General.8
4.2.1.2 Antennas.8
4.2.1.3 Controls.8
4.2.1.4 Transmitter shut-off facility.8
4.2.2 Frequency error.8
4.2.2.1 Definition.8
4.2.2.2 Limits.9
4.2.2.3 Conformance.9
4.2.3 Emission bandwidth.9
4.2.3.1 Definition.9
4.2.3.2 Limits.9
4.2.3.3 Conformance.9
4.2.4 Effective radiated power of the fundamental emission.9
4.2.4.1 Definition.9
4.2.4.2 Limits.9
4.2.4.3 Conformance.9
4.2.5 Spurious emissions.9
4.2.5.1 Definition.9
4.2.5.2 Limits.9
4.2.5.3 Conformance.9
4.2.6 Frequency stability under low voltage conditions .10
4.2.6.1 Definition.10
4.2.6.2 Limits.10
4.2.6.3 Conformance.10
4.2.7 Spurious radiation of receivers .10
4.2.7.1 Definition.10
4.2.7.2 Limits.10
4.2.7.3 Conformance.10
4.2.8 Spectrum access.10
4.2.8.1 LBT/AFA spectrum access.10
4.2.8.1.1 Definition.10
4.2.8.1.2 Limits.10
4.2.8.1.3 Conformance .10
4.2.8.2 Low Power Low Duty Cycle spectrum access.11
4.2.8.2.1 Definition.11
4.2.8.2.2 Limits for low duty cycle low power spectrum access .11
4.2.8.2.3 Conformance .11
5 Testing for compliance with technical requirements.11
5.1 Environmental conditions for testing .11
5.2 Interpretation of the measurement results .11
ETSI
4 ETSI EN 302 537-2 V1.1.2 (2007-12)
5.3 Essential radio test suites.12
5.3.1 Frequency error.12
5.3.2 Emission bandwidth.12
5.3.3 Effective radiated power of the fundamental emission.12
5.3.4 Spurious emissions.12
5.3.5 Frequency stability under low voltage conditions .12
5.3.6 Spurious radiation of receivers .12
5.3.7 Spectrum access for systems using LBT/AFA.13
5.3.8 Spectrum access for devices using low power and low duty cycle.13
5.3.9 Normal and extreme test-conditions .13
5.3.10 Test power source .13
5.3.11 Choice of samples for test suites.13
Annex A (normative): HS Requirements and conformance Test specifications Table (HS-
RTT).14
Annex B (informative): The EN title in the official languages .17
Annex C (informative): Bibliography.19
History .20

ETSI
5 ETSI EN 302 537-2 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 Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM).
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC [3] (as amended) laying down a procedure for the provision of information in the
field of technical standards and regulations.
The present document is intended to become a Harmonized Standard, the reference of which will be published in the
Official Journal of the European Communities referencing the 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) [6].
Technical specifications relevant to Directive 1999/5/EC are given in annex A.
The present document is part 2 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 [4]
and Active Medical Implants and Peripherals the medical section of which is regulated under the Active Implantable
Medical Device Directive [4], 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 2009

ETSI
6 ETSI EN 302 537-2 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 that will use the data to diagnose and 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 [4] (MDD) or the Active Implantable Medical Device Directive
(AIMD [7]). 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 sensor or handheld devices that are intended to operate in very close proximity to the human
body, including touching the body, whose radio antenna 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 [5] 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.
In addition to the present document, other ENs that specify technical requirements in respect of essential requirements
under other parts of article 3 of the R&TTE Directive [6] will apply to equipment within the scope of the present
document.
ETSI
7 ETSI EN 302 537-2 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 EN 302 537-1 (V1.2.1): "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 TR 100 028 (V1.4.1): "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
2.2 Informative references
[3] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations.
[4] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MD Directive).
[5] CEPT/ERC/REC 70-03 (2006): "Relating to the use of Short Range Devices (SRD)".
[6] 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).
[7] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices.
ETSI
8 ETSI EN 302 537-2 V1.1.2 (2007-12)
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in EN 302 537-1 [1], clause 3.1 apply.
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in EN 302 537-1 [1], clause 3.3 apply.
4 Technical requirements and specifications
4.1 Environmental profile
The technical requirements of the present document apply under the environmental profile for operation of the
equipment as described in the user's manual and declared by the provider. The equipment shall comply with all the
technical requirements of the present document at all times when operating within the boundary limits of the operational
environmental profile as described above. The provider shall declare that interruption of the communications link for
his MEDS system shall not result in compromising the health and safety of the patient.
4.2 Conformance requirements
4.2.1 Mechanical and electrical design
4.2.1.1 General
The equipment shall be designed, constructed and manufactured in accordance with sound engineering practice and
with the aim of minimizing
...

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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
Ta slovenski standard je istoveten z: EN 302 537-2 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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Harmonized 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 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

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

Reference
DEN/ERM-TG30-005-2
Keywords
health, regulation, 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 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.
ETSI
3 ETSI EN 302 537-2 V1.1.2 (2007-12)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.7
2.1 Normative references.7
2.2 Informative references.7
3 Definitions and abbreviations.8
3.1 Definitions.8
3.2 Abbreviations.8
4 Technical requirements and specifications.8
4.1 Environmental profile.8
4.2 Conformance requirements.8
4.2.1 Mechanical and electrical design .8
4.2.1.1 General.8
4.2.1.2 Antennas.8
4.2.1.3 Controls.8
4.2.1.4 Transmitter shut-off facility.8
4.2.2 Frequency error.8
4.2.2.1 Definition.8
4.2.2.2 Limits.9
4.2.2.3 Conformance.9
4.2.3 Emission bandwidth.9
4.2.3.1 Definition.9
4.2.3.2 Limits.9
4.2.3.3 Conformance.9
4.2.4 Effective radiated power of the fundamental emission.9
4.2.4.1 Definition.9
4.2.4.2 Limits.9
4.2.4.3 Conformance.9
4.2.5 Spurious emissions.9
4.2.5.1 Definition.9
4.2.5.2 Limits.9
4.2.5.3 Conformance.9
4.2.6 Frequency stability under low voltage conditions .10
4.2.6.1 Definition.10
4.2.6.2 Limits.10
4.2.6.3 Conformance.10
4.2.7 Spurious radiation of receivers .10
4.2.7.1 Definition.10
4.2.7.2 Limits.10
4.2.7.3 Conformance.10
4.2.8 Spectrum access.10
4.2.8.1 LBT/AFA spectrum access.10
4.2.8.1.1 Definition.10
4.2.8.1.2 Limits.10
4.2.8.1.3 Conformance .10
4.2.8.2 Low Power Low Duty Cycle spectrum access.11
4.2.8.2.1 Definition.11
4.2.8.2.2 Limits for low duty cycle low power spectrum access .11
4.2.8.2.3 Conformance .11
5 Testing for compliance with technical requirements.11
5.1 Environmental conditions for testing .11
5.2 Interpretation of the measurement results .11
ETSI
4 ETSI EN 302 537-2 V1.1.2 (2007-12)
5.3 Essential radio test suites.12
5.3.1 Frequency error.12
5.3.2 Emission bandwidth.12
5.3.3 Effective radiated power of the fundamental emission.12
5.3.4 Spurious emissions.12
5.3.5 Frequency stability under low voltage conditions .12
5.3.6 Spurious radiation of receivers .12
5.3.7 Spectrum access for systems using LBT/AFA.13
5.3.8 Spectrum access for devices using low power and low duty cycle.13
5.3.9 Normal and extreme test-conditions .13
5.3.10 Test power source .13
5.3.11 Choice of samples for test suites.13
Annex A (normative): HS Requirements and conformance Test specifications Table (HS-
RTT).14
Annex B (informative): The EN title in the official languages .17
Annex C (informative): Bibliography.19
History .20

ETSI
5 ETSI EN 302 537-2 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 Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM).
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC [3] (as amended) laying down a procedure for the provision of information in the
field of technical standards and regulations.
The present document is intended to become a Harmonized Standard, the reference of which will be published in the
Official Journal of the European Communities referencing the 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) [6].
Technical specifications relevant to Directive 1999/5/EC are given in annex A.
The present document is part 2 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 [4]
and Active Medical Implants and Peripherals the medical section of which is regulated under the Active Implantable
Medical Device Directive [4], 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 2009

ETSI
6 ETSI EN 302 537-2 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 that will use the data to diagnose and 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 [4] (MDD) or the Active Implantable Medical Device Directive
(AIMD [7]). 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 sensor or handheld devices that are intended to operate in very close proximity to the human
body, including touching the body, whose radio antenna 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 [5] 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.
In addition to the present document, other ENs that specify technical requirements in respect of essential requirements
under other parts of article 3 of the R&TTE Directive [6] will apply to equipment within the scope of the present
document.
ETSI
7 ETSI EN 302 537-2 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 EN 302 537-1 (V1.2.1): "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 TR 100 028 (V1.4.1): "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
2.2 Informative references
[3] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations.
[4] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MD Directive).
[5] CEPT/ERC/REC 70-03 (2006): "Relating to the use of Short Range Devices (SRD)".
[6] 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).
[7] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices.
ETSI
8 ETSI EN 302 537-2 V1.1.2 (2007-12)
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in EN 302 537-1 [1], clause 3.1 apply.
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in EN 302 537-1 [1], clause 3.3 apply.
4 Technical requirements and specifications
4.1 Environmental profile
The technical requirements of the present document apply under the environmental profile for operation of the
equipment as described in the user's manual and declared by the provider. The equipment shall comply with all the
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