SIST EN 301 839-2 V1.3.1:2009

• Abstract:

  The present document specifies requirements for ULP-AMI and peripherals including specific requirements for LBT and operating channel selection which external devices must use to select clear spectrum for a communications session. It is proposed to provide additional provisions to allow implanted devices to perform the LBT and operating channel selection functions for communications between implanted devices.

• Status: Published
• Public Enquiry End Date: 31-Mar-2009
• Publication Date: 15-Nov-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 33.060.20 - Receiving and transmitting equipment
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: MOC - Mobile Communications
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-Oct-2009
• Due Date: 25-Dec-2009
• Completion Date: 16-Nov-2009
• 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
  Conflicting Date: 30-Jun-2011
• Directive:

  ---

  TRRTP124 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-4)
• Mandate: M/284
• Ref Project: ETSI EN 301 839-2 V1.3.1 (2009-10) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Overview

SIST EN 301 839-2 V1.3.1:2009 is a harmonized European standard developed under the framework of electromagnetic compatibility and radio spectrum matters (ERM) for short range devices (SRD). Specifically, this standard addresses Ultra Low Power Active Medical Implants (ULP-AMI) and their peripherals (ULP-AMI-P) operating in the 402 MHz to 405 MHz frequency band. The document aligns with the essential requirements of article 3.2 of the R&TTE Directive (1999/5/EC), which ensures that radio equipment effectively uses the allocated spectrum and does not cause harmful interference.

The purpose of this standard is to detail technical specifications and conformance requirements that support both the functional safety of medical implants and the efficient management of the radio spectrum, thereby contributing to reliable, interference-free operation of essential medical devices.

Key Topics

• Frequency range: Applies to ULP-AMI and ULP-AMI-P in the 402 MHz to 405 MHz spectrum allocated for medical implant communications.
• Electromagnetic compatibility (EMC): Sets requirements to minimize adverse interactions with other wireless systems and ensure device immunity from external interference.
• Spectrum access and control: Defines mandatory spectrum access methods, such as Listen-Before-Talk (LBT) and operating channel selection, to reduce risk of interference.
• Technical design requirements: Includes conformance criteria for:
  • Mechanical and electrical design (including antennas and transmitter shut-off facilities)
  • Frequency accuracy and stability (including under low voltage)
  • Spurious emissions and radiated power limits for both transmitters and receivers
  • Emission bandwidth
• Testing and compliance: Outlines essential test suites, environmental test conditions, and interpretation of measurement uncertainties to ensure consistent assessment.
• Conformance procedures: Identifies which requirements are unconditional and which may depend on the specific equipment functionality, and provides references to appropriate test specifications.

Applications

The standard is crucial for:

• Medical device manufacturers: Ensuring that ultra low power medical implants and their wireless peripherals meet regulatory requirements, perform reliably, and avoid interference with other devices in the allocated spectrum.
• Regulatory compliance: Demonstrating conformance to the R&TTE Directive, enabling CE marking and market access within the European Economic Area.
• Telecommunications and healthcare providers: Supporting the deployment of safe, reliable wireless medical implant communications essential for diagnosis, treatment, and patient monitoring.
• Testing laboratories: Providing standardized procedures for assessing compliance with electromagnetic compatibility and radio spectrum use, facilitating consistent evaluation and reporting.
• Spectrum management: Ensuring efficient use of the 402 MHz to 405 MHz band for critical medical applications, minimizing risk to patient safety and protecting public spectrum resources.

Related Standards

• EN 301 839-1: Technical characteristics and test methods for ULP-AMI and ULP-AMI-P; provides foundational definitions, referenced extensively for details on limits and test procedures.
• ETSI TR 100 028: Guidance on measurement uncertainties in mobile radio equipment testing.
• Council Directive 90/385/EEC: Covers active implantable medical devices’ safety and design requirements.
• R&TTE Directive (1999/5/EC): Establishes essential requirements for radio equipment, including spectrum efficiency and avoidance of harmful interference.
• Related EMC and safety directives: For electromagnetic compatibility and electrical safety relevant to medical devices.

Summary

SIST EN 301 839-2 V1.3.1:2009 is a critical harmonized standard for ultra low power active medical implants and peripherals, ensuring electromagnetic compatibility, radio spectrum efficiency, and compliance with European directives. By specifying stringent requirements for design, operation, and testing, it enables safe, interference-free deployment of lifesaving medical technologies across Europe. For manufacturers, regulators, and healthcare providers, this standard is an essential reference in the evolution of wireless medical device innovation.

Draft ETSI EN 301 839-2 V1.3.1 (2009-01)
Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

2 Draft ETSI EN 301 839-2 V1.3.1 (2009-01)

Reference
REN/ERM-TG30-263-2
Keywords
radio, regulation, SRD, testing
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 2009.
All rights reserved.
TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 Draft ETSI EN 301 839-2 V1.3.1 (2009-01)
Contents
Intellectual Property Rights . 5
Foreword . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 7
4 Technical requirements and specifications . 7
4.1 Environmental profile . 7
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 . 8
4.2.2.3 Conformance . 8
4.2.3 Emission bandwidth . 8
4.2.3.1 Definition . 8
4.2.3.2 Limits . 8
4.2.3.3 Conformance . 8
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 of transmitter . 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 . 9
4.2.6.1 Definition . 9
4.2.6.2 Limits . 9
4.2.6.3 Conformance . 9
4.2.7 Spurious radiation of receivers . 9
4.2.7.1 Definition . 9
4.2.7.2 Limits . 9
4.2.7.3 Conformance . 9
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
4.2.8.2 LP/LDC spectrum access . 10
4.2.8.2.1 Definition. 10
4.2.8.2.2 Limits . 10
4.2.8.3 Conformance . 10
5 Testing for compliance with technical requirements . 11
5.1 Environmental conditions for testing . 11
5.2 Interpretation of the measurement results . 11
5.3 Essential radio test suites . 11
ETSI
4 Draft ETSI EN 301 839-2 V1.3.1 (2009-01)
5.3.1 Frequency error . 11
5.3.2 Emission bandwidth . 12
5.3.3 Effective radiated power of the fundamental emission . 12
5.3.4 Spurious emissions of transmitter . 12
5.3.5 Frequency stability under low voltage conditions . 12
5.3.6 Spurious radiation of receivers . 12
5.3.7 Spectrum Access . 12
5.3.7.1 LBT/AFA spectrum access . 12
5.3.7.2 LP/LDC spectrum access . 12
5.3.8 Normal and extreme test-conditions . 12
5.3.9 Test power source . 12
5.3.10 Choice of samples for test suites . 12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT) . 13
Annex B (informative): The EN title in the official languages . 15
Annex C (informative): Bibliography . 16
History . 17

ETSI
5 Draft ETSI EN 301 839-2 V1.3.1 (2009-01)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://webapp.etsi.org/IPR/home.asp).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM), and is now submitted for the Public Enquiry phase
of the ETSI standards Two-step Approval Procedure.
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC (as amended) [i.3] 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 [i.1] 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 ("the R&TTE Directive") [i.1].
Technical specifications relevant to Directive 1999/5/EC [i.1] are given in annex A.
The present document is part 2 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa

ETSI
6 Draft ETSI EN 301 839-2 V1.3.1 (2009-01)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI);
• and Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands in table 1.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Transmit Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
Receive Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)

The present document is intended to cover the provisions of Directive 1999/5/EC [i.1] (R&TTE Directive).
Article 3.2, which states that "…. radio equipment shall be so constructed that it effectively uses the spectrum allocated
to terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.2]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC [i.1].
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 [i.1] may apply to equipment within the scope of the present
document.
NOTE: A list of such ENs is included on the web site http://www.newapproach.org.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
For online referenced documents, information sufficient to identify and locate the source shall be provided. Preferably,
the primary source of the referenced document should be cited, in order to ensure traceability. Furthermore, the
reference should, as far as possible, remain valid for the expected life of the document. The reference shall include the
method of access to the referenced document and the full network address, with the same punctuation and use of upper
case and lower case letters.
NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee
their long term validity.
ETSI
...

Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

2 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)

Reference
REN/ERM-TG30-263-2
Keywords
radio, regulation, SRD, testing
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 2009.
All rights reserved.
TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
Contents
Intellectual Property Rights . 5
Foreword . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 7
4 Technical requirements and specifications . 7
4.1 Environmental profile . 7
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 . 8
4.2.2.3 Conformance . 8
4.2.3 Emission bandwidth . 8
4.2.3.1 Definition . 8
4.2.3.2 Limits . 8
4.2.3.3 Conformance . 8
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 of transmitter . 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 . 9
4.2.6.1 Definition . 9
4.2.6.2 Limits . 9
4.2.6.3 Conformance . 9
4.2.7 Spurious radiation of receivers . 9
4.2.7.1 Definition . 9
4.2.7.2 Limits . 9
4.2.7.3 Conformance . 9
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
4.2.8.2 LP/LDC spectrum access . 10
4.2.8.2.1 Definition. 10
4.2.8.2.2 Limits . 10
4.2.8.3 Conformance . 10
5 Testing for compliance with technical requirements . 11
5.1 Environmental conditions for testing . 11
5.2 Interpretation of the measurement results . 11
5.3 Essential radio test suites . 11
ETSI
4 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
5.3.1 Frequency error . 11
5.3.2 Emission bandwidth . 12
5.3.3 Effective radiated power of the fundamental emission . 12
5.3.4 Spurious emissions of transmitter . 12
5.3.5 Frequency stability under low voltage conditions . 12
5.3.6 Spurious radiation of receivers . 12
5.3.7 Spectrum Access . 12
5.3.7.1 LBT/AFA spectrum access . 12
5.3.7.2 LP/LDC spectrum access . 12
5.3.8 Normal and extreme test-conditions . 12
5.3.9 Test power source . 12
5.3.10 Choice of samples for test suites . 12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT) . 13
Annex B (informative): The EN title in the official languages . 15
Annex C (informative): Bibliography . 16
History . 17

ETSI
5 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://webapp.etsi.org/IPR/home.asp).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM), and is now submitted for the Vote phase of the
ETSI standards Two-step Approval Procedure.
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC (as amended) [i.3] 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 [i.1] 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 ("the R&TTE Directive") [i.1].
Technical specifications relevant to Directive 1999/5/EC [i.1] are given in annex A.
The present document is part 2 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa

ETSI
6 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI);
• and Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands in table 1.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Transmit Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
Receive Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)

The present document is intended to cover the provisions of Directive 1999/5/EC [i.1] (R&TTE Directive), Article 3.2,
which states that "…. radio equipment shall be so constructed that it effectively uses the spectrum allocated to
terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.2]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC [i.1].
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 [i.1] may apply to equipment within the scope of the present
document.
NOTE: A list of such ENs is included on the web site http://www.newapproach.org.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee
their long term validity.
ETSI
7 Final draft ETSI EN 301 839-2 V1.3.1 (2009-07)
2.1 Normative references
The following referenced documents are indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest ed
...

Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P)
operating in the frequency range 402 MHz to 405 MHz;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

2 ETSI EN 301 839-2 V1.3.1 (2009-10)

Reference
REN/ERM-TG30-263-2
Keywords
radio, regulation, SRD, testing
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 2009.
All rights reserved.
TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 ETSI EN 301 839-2 V1.3.1 (2009-10)
Contents
Intellectual Property Rights . 5
Foreword . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 7
4 Technical requirements and specifications . 7
4.1 Environmental profile . 7
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 . 8
4.2.2.3 Conformance . 8
4.2.3 Emission bandwidth . 8
4.2.3.1 Definition . 8
4.2.3.2 Limits . 8
4.2.3.3 Conformance . 8
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 of transmitter . 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 . 9
4.2.6.1 Definition . 9
4.2.6.2 Limits . 9
4.2.6.3 Conformance . 9
4.2.7 Spurious radiation of receivers . 9
4.2.7.1 Definition . 9
4.2.7.2 Limits . 9
4.2.7.3 Conformance . 9
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
4.2.8.2 LP/LDC spectrum access . 10
4.2.8.2.1 Definition. 10
4.2.8.2.2 Limits . 10
4.2.8.3 Conformance . 10
5 Testing for compliance with technical requirements . 11
5.1 Environmental conditions for testing . 11
5.2 Interpretation of the measurement results . 11
5.3 Essential radio test suites . 11
ETSI
4 ETSI EN 301 839-2 V1.3.1 (2009-10)
5.3.1 Frequency error . 11
5.3.2 Emission bandwidth . 12
5.3.3 Effective radiated power of the fundamental emission . 12
5.3.4 Spurious emissions of transmitter . 12
5.3.5 Frequency stability under low voltage conditions . 12
5.3.6 Spurious radiation of receivers . 12
5.3.7 Spectrum Access . 12
5.3.7.1 LBT/AFA spectrum access . 12
5.3.7.2 LP/LDC spectrum access . 12
5.3.8 Normal and extreme test-conditions . 12
5.3.9 Test power source . 12
5.3.10 Choice of samples for test suites . 12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT) . 13
Annex B (informative): The EN title in the official languages . 15
Annex C (informative): Bibliography . 16
History . 17

ETSI
5 ETSI EN 301 839-2 V1.3.1 (2009-10)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://webapp.etsi.org/IPR/home.asp).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This 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 (as amended) [i.3] 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 [i.1] 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 ("the R&TTE Directive") [i.1].
Technical specifications relevant to Directive 1999/5/EC [i.1] are given in annex A.
The present document is part 2 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power
Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to
405 MHz, as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".

National transposition dates
Date of adoption of this EN: 28 September 2009
Date of latest announcement of this EN (doa): 31 December 2009
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2010
Date of withdrawal of any conflicting National Standard (dow): 30 June 2011

ETSI
6 ETSI EN 301 839-2 V1.3.1 (2009-10)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI);
• and Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands in table 1.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Transmit Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
Receive Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)

The present document is intended to cover the provisions of Directive 1999/5/EC [i.1] (R&TTE Directive), Article 3.2,
which states that "…. radio equipment shall be so constructed that it effectively uses the spectrum allocated to
terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.2]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC [i.1].
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 [i.1] may apply to equipment within the scope of the present
document.
NOTE: A list of such ENs is included on the web site http://www.newapproach.org.
2 References
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific.
• For a specific reference, subsequent revisions do not apply.
• Non-specific reference may be made only to a complete document or a part thereof and only in the following
cases:
- if it is accepted that it will be possible to use all future changes of the referenced document for the
purposes of the referring document;
- for informative references.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee
their long term validity.
ETSI
7 ETSI EN 301 839-2 V1.3.1 (2009-10)
2.1 Normative references
The following referenced documents are indispensable for the application of the present document. For dated
references, only the edition cited applies. For non-specific references, the latest edition of the referenced document
(in
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 301 839-2 Version 1.3.1SIST EN 301 839-2 V1.3.1:2009en01-december-2009SIST EN 301 839-2 V1.3.1:2009SLOVENSKI
STANDARD
ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 2
Reference REN/ERM-TG30-263-2 Keywords radio, regulation, SRD, testing 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 2009. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. LTE™ is a Trade Mark of ETSI currently being registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 301 839-2 V1.3.1:2009

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 3 Contents Intellectual Property Rights . 5 Foreword . 5 1 Scope . 6 2 References . 6 2.1 Normative references . 7 2.2 Informative references . 7 3 Definitions and abbreviations . 7 3.1 Definitions . 7 3.2 Abbreviations . 7 4 Technical requirements and specifications . 7 4.1 Environmental profile . 7 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 . 8 4.2.2.3 Conformance . 8 4.2.3 Emission bandwidth . 8 4.2.3.1 Definition . 8 4.2.3.2 Limits . 8 4.2.3.3 Conformance . 8 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 of transmitter . 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 . 9 4.2.6.1 Definition . 9 4.2.6.2 Limits . 9 4.2.6.3 Conformance . 9 4.2.7 Spurious radiation of receivers . 9 4.2.7.1 Definition . 9 4.2.7.2 Limits . 9 4.2.7.3 Conformance . 9 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 4.2.8.2 LP/LDC spectrum access . 10 4.2.8.2.1 Definition. 10 4.2.8.2.2 Limits . 10 4.2.8.3 Conformance . 10 5 Testing for compliance with technical requirements . 11 5.1 Environmental conditions for testing . 11 5.2 Interpretation of the measurement results . 11 5.3 Essential radio test suites . 11 SIST EN 301 839-2 V1.3.1:2009

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 4 5.3.1 Frequency error . 11 5.3.2 Emission bandwidth . 12 5.3.3 Effective radiated power of the fundamental emission . 12 5.3.4 Spurious emissions of transmitter . 12 5.3.5 Frequency stability under low voltage conditions . 12 5.3.6 Spurious radiation of receivers . 12 5.3.7 Spectrum Access . 12 5.3.7.1 LBT/AFA spectrum access . 12 5.3.7.2 LP/LDC spectrum access . 12 5.3.8 Normal and extreme test-conditions . 12 5.3.9 Test power source . 12 5.3.10 Choice of samples for test suites . 12 Annex A (normative): HS Requirements and conformance Test specifications Table (HS-RTT) . 13 Annex B (informative): The EN title in the official languages . 15 Annex C (informative): Bibliography . 16 History . 17
ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 5 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 (as amended) [i.3] 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 [i.1] 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 ("the R&TTE Directive") [i.1]. Technical specifications relevant to Directive 1999/5/EC [i.1] are given in annex A. The present document is part 2 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz, as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 28 September 2009 Date of latest announcement of this EN (doa): 31 December 2009 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 June 2010 Date of withdrawal of any conflicting National Standard (dow): 30 June 2011
ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 6 1 Scope The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI); • and Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) service frequency bands Transmit Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz
The present document is intended to cover the provisions of Directive 1999/5/EC [i.1] (R&TTE Directive), Article 3.2, which states that "…. radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference". An AIMD is regulated under the AIMD Directive 90/385/EEC [i.2]: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC [i.1]. 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 [i.1] may apply to equipment within the scope of the present document. NOTE: A list of such ENs is included on the web site http://www.newapproach.org. 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
...