SIST EN 301 839-2 V1.2.1:2007

• Abstract:

  EN 301 839 shall be revised: 1. Generic definitions shall be used and inconsistencies be removed in EN 301 839-1 and -2. 2. At present EN 301 839-1 describes LBT as interference mitigation technology. It is suggested that also an alternative interference mitigation technology is introduced in EN 301 839-1. Possible candidates for this interference mitigation technology are: a duty cycle limitation to less than 0.1% a duty cycle limitation to less than 0.1% on one channel (300 kHz bandwidth) a power reduction to less than 250 nW Devices respecting this interference mitigation technology can coexist with devices using LBT. Note: subject referred to RM for considerations as agreed at ERM#23 (see summary record); 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 given below.; The present document is intended to cover the provisions of Directive 1999/5/EC [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 [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 [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 [1] may apply to equipment within the scope of the present document.

• Status: Published
• Publication Date: 08-Nov-2007
• 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: 25-Oct-2007
• Due Date: 30-Dec-2007
• Completion Date: 09-Nov-2007
• 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
• Mandate: M/284
• Ref Project: ETSI EN 301 839-2 V1.2.1 (2007-04) - 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

• Official Journal Project Relation: SIST EN 301 839-2 V1.1.1:2003 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
• Effective Date: 25-Jan-2010

Overview

SIST EN 301 839-2 V1.2.1:2007 is a harmonized European standard that specifies essential requirements for electromagnetic compatibility (EMC) and radio spectrum use for Ultra Low Power Active Medical Implants (ULP-AMI) and their peripherals (ULP-AMI-P). The standard applies to devices operating in the 402 MHz to 405 MHz frequency range and supports compliance with Article 3.2 of the EU R&TTE Directive (1999/5/EC), which requires radio equipment to use spectrum efficiently while preventing harmful interference. This standard is particularly important for manufacturers and stakeholders involved in the design, production, and deployment of medical implants and their associated wireless communication devices.

Key Topics

• Electromagnetic Compatibility (EMC): Outlines the requirements for minimizing electromagnetic interference between implants, peripherals, and other electronic devices.
• Radio Spectrum Matters: Ensures efficient and interference-free use of the 402-405 MHz band for medical communications.
• Device Types Covered:
  • Ultra Low Power Active Medical Implants (ULP-AMI)
  • Associated Peripherals (ULP-AMI-P)
• Technical Requirements:
  • Mechanical and electrical design
  • Antenna specifications and controls to mitigate interference
  • Transmitter shut-off facilities and frequency stability
  • Limits for emission bandwidth and spurious emissions
  • Spectrum access methods (such as Listen Before Talk, low power, and low duty cycle)
• Testing and Conformance:
  • Defines measurement standards for frequency error, emission bandwidth, radiated power, and more
  • Describes procedures and measurement uncertainties for compliance testing

Applications

The standard is crucial for the manufacture and deployment of active implantable medical devices and peripherals, ensuring:

• Patient Safety: By reducing interference, the standard ensures reliable operation of implants like pacemakers and neurostimulators.
• Regulatory Compliance: Enables manufacturers to demonstrate compliance with EU requirements, facilitating market access across Europe.
• Quality Assurance: Provides a benchmark for testing and certifying equipment, supporting robust device performance and interoperability.
• Innovation Support: Facilitates the introduction of new implantable technologies within a harmonized regulatory framework, promoting advancement in medical device design and wireless medical telemetry.

Related Standards

• EN 301 839-1: Specifies technical characteristics and test methods for ULP-AMI and ULP-AMI-P.
• Directive 1999/5/EC (R&TTE Directive): Governs radio equipment and telecommunications terminal equipment in the EU.
• Directive 90/385/EEC: Addresses active implantable medical devices (AIMDs) at the EU level.
• ETSI TR 100 028: Covers measurement uncertainties in mobile radio equipment testing.

Adherence to SIST EN 301 839-2 V1.2.1:2007 helps stakeholders in the active medical implant ecosystem align with European best practices for electromagnetic compatibility, spectrum efficiency, and regulatory compliance, which are essential for reliable, safe, and innovative wireless medical device solutions.

SLOVENSKI STANDARD
01-december-2007
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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
Ta slovenski standard je istoveten z: EN 301 839-2 Version 1.2.1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
33.060.20 Sprejemna in oddajna Receiving and transmitting
oprema equipment
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.

ETSI EN 301 839-2 V1.2.1 (2007-07)
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 ETSI EN 301 839-2 V1.2.1 (2007-07)

Reference
REN/ERM-TG30-002-2
Keywords
radio, regulation, SRD, testing
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ETSI
3 ETSI EN 301 839-2 V1.2.1 (2007-07)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.6
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.7
4.2.1 Mechanical and electrical design .7
4.2.1.1 General.7
4.2.1.2 Antennas.7
4.2.1.3 Controls.7
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.8
4.2.4.1 Definition.8
4.2.4.2 Limits.8
4.2.4.3 Conformance.8
4.2.5 Spurious emissions of transmitter.8
4.2.5.1 Definition.8
4.2.5.2 Limits.8
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.9
4.2.8.1 LBT/AFA spectrum access.9
4.2.8.1.1 Definition.9
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.10
5.1 Environmental conditions for testing .10
5.2 Interpretation of the measurement results .10
5.3 Essential radio test suites.11
5.3.1 Frequency error.11
5.3.2 Emission bandwidth.11
ETSI
4 ETSI EN 301 839-2 V1.2.1 (2007-07)
5.3.3 Effective radiated power of the fundamental emission.11
5.3.4 Spurious emissions of transmitter.11
5.3.5 Frequency stability under low voltage conditions .11
5.3.6 Spurious radiation of receivers .11
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.17
History .18

ETSI
5 ETSI EN 301 839-2 V1.2.1 (2007-07)
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).
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) [5] 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 ("the R&TTE Directive") [1].
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 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: 29 June 2007
Date of latest announcement of this EN (doa): 30 September 2007
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 March 2008
Date of withdrawal of any conflicting National Standard (dow): 31 March 2009

ETSI
6 ETSI EN 301 839-2 V1.2.1 (2007-07)
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 given below.
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 [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 [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 [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 [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
The following documents contain provisions which, through reference in this text, constitute provisions of the present
document.
• 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.
• For a non-specific reference, the latest version applies.
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.
[1] 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).
[2] 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
7 ETSI EN 301 839-2 V1.2.1 (2007-07)
[3] ETSI EN 301 839-1 (V1.2.1): "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 1: Technical characteristics and test methods".
[4] ETSI TR 100 028 (V1.4.1): "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[5] 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.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in EN 301 839-1 [3], clause 3.1 apply.
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in EN 301 839-1 [3], 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, which shall be declared by the manufacturer. The equipment shall comply with all the technical
requirements of the present document at all times when operating within the boundary limits of the declared operational
environmental profile.
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 harmful interference to other equipment and services and should not receive harmful
interference from other electronic devices. Transmitters and receivers may be individual or combination units.
4.2.1.2 Antennas
Equipment operating in the 402 MHz to 405 MHz band shall have an integral antenna, an external dedicated antenna or
both. If provision for an external antenna connection is made, the manufacturer or provider shall make provision to
prevent the use of an antenna other than that authorized by the manufacturer or provider.
4.2.1.3 Controls
Those controls that, if maladjusted, might increase the interference potentialities of the equipment shall not be easily
accessible to the user.
ETSI
8 ETSI EN 301 839-2 V1.2.1 (2007-07)
4.2.1.4 Transmitter shut-off facility
If the transmitter is equipped with an automatic transmitter shut-off facility or battery-saving feature and it interferes
with testing of the device, it shall be capable of being made inoperative for the purpose of testing.
4.2.2 Frequency error
4.2.2.1 Definition
The frequency error shall be
...