SIST EN 302 510-2 V1.1.1:2007

• Abstract:

  The present document applies to Ultra Low Power-Active Medical Implants (ULP-AMI), Membrane Implants, and accessories as described in Directive 90/385/EEC [6], operating in a Medical Implant Communications System (MICS) in the frequency band 30 MHz to 37,5 MHz. An AIMD is regulated under the AIMD Directive 90/385/EEC [6]: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the R&TTE Directive 1999/5/EC [1].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". 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] will apply to equipment within the scope of the present document.

• Status: Published
• Publication Date: 05-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: 06-Nov-2007
• Directive: 2005-01-1864 - Pravilnik o radijskih frekvencah, ki se smejo uporabljati brez odločbe o dodelitvi radijskih frekvenc
• Directive:

  ---

  2014/53/EU - Directive 2014/53/EU of The European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
  OJ Date: 08-Jun-2017
• Directive:

  ---

  TRRTP124 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-4)
• Ref Project: ETSI EN 302 510-2 V1.1.1 (2007-07) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Overview

SIST EN 302 510-2 V1.1.1:2007 provides the harmonized European requirements for electromagnetic compatibility (EMC) and radio spectrum use for ultra low power active medical membrane implants and their accessories. It covers radio equipment operating in the frequency band 30 MHz to 37.5 MHz, as part of Medical Implant Communication Systems (MICS). This standard ensures devices meet the essential requirements of Article 3.2 of the R&TTE Directive (1999/5/EC), focusing on the efficient use of radio spectrum and the prevention of harmful interference.

By aligning with these requirements, manufacturers benefit from presumption of conformity when placing devices on the European market, streamlining the regulatory process and enhancing safety and interoperability of medical implant devices.

Key Topics

• Regulatory Context:

  • Compliance with R&TTE Directive 1999/5/EC, specifically Article 3.2 regarding spectrum use and interference avoidance.
  • Consistency with Directive 90/385/EEC for active implantable medical devices.

• Technical Requirements:

  • Mechanical and Electrical Design: Equipment must be designed to minimize electromagnetic disturbance and to resist interference.
  • Antenna Specifications: Devices may utilize integral or dedicated antennas, with safeguards on connector types to avoid incorrect usage.
  • User Controls: Controls that could increase interference must not be easily accessible.
  • Transmitter Shut-off: Provision for disabling automatic shut-off features during compliance testing.

• Radio Performance Criteria:

  • Maximum Effective Radiated Power: Ensures radiated output is within specified boundaries.
  • Out of Band Emissions: Limits emissions outside the allocated frequency band.
  • Spurious Emissions: Controls unwanted emissions that may cause interference.
  • Duty Cycle Restrictions: Sets maximum transmission periods within specified intervals.
  • Receiver Performance: Addresses susceptibility to blocking and spurious reception.

• Testing and Conformance:

  • Defines test methods for verifying conformance with all essential requirements.
  • Outlines environmental conditions, test sample selection, and measurement uncertainties.

Applications

SIST EN 302 510-2 V1.1.1:2007 is applicable to:

• Ultra Low Power Active Medical Membrane Implants (ULP-AMI): Including devices regulated under the AIMD Directive, such as active implants for surgical or therapeutic purposes.
• Medical Implant Communication Systems (MICS): Ensuring safe, reliable wireless communication with implanted medical devices.
• Accessories for Implants: Peripheral devices supporting communication, diagnostics, and monitoring of implant operation.

These devices are essential in health care environments requiring stringent controls on electromagnetic compatibility and radio spectrum usage to protect both patient safety and reliable device performance.

Related Standards

• EN 302 510-1: Covers technical characteristics and test methods for ULP-AMI equipment.
• Directive 1999/5/EC (R&TTE Directive): Lays down essential requirements for radio equipment.
• Directive 90/385/EEC: Regulates active implantable medical devices in the European Union.
• EN 301 489: EMI/EMC requirements for radio equipment (including medical devices).
• TR 100 028: Guidelines on measurement uncertainties for mobile radio equipment.

These related standards collectively address the full spectrum of EMC, safety, and radio communications requirements for medical implant technologies and help manufacturers achieve comprehensive compliance.

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By adhering to SIST EN 302 510-2 V1.1.1:2007, device manufacturers ensure their medical membrane implants and associated accessories provide reliable, interference-free operation, facilitating safer patient outcomes and market access within the European Union.

SLOVENSKI STANDARD
01-december-2007
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Electromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in
the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane
Implants and Accessories - Part 2: Harmonized EN covering essential requirements of
article 3.2 of the R&TTE Directive
Ta slovenski standard je istoveten z: EN 302 510-2 Version 1.1.1
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.

Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Radio equipment in the frequency range
30 MHz to 37,5 MHz for Ultra Low Power Active
Medical Membrane Implants and Accessories;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

2 ETSI EN 302 510-2 V1.1.1 (2007-07)

Reference
DEN/ERM-TG30-003-2
Keywords
radio, regulation, SRD, testing
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ETSI
3 ETSI EN 302 510-2 V1.1.1 (2007-07)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.6
3 Definitions, symbols and abbreviations .7
3.1 Definitions.7
3.2 Symbols.7
3.3 Abbreviations.7
4 Technical requirements 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.7
4.2.2 Maximum effective radiated power of the fundamental .8
4.2.2.1 Definition.8
4.2.2.2 Limits.8
4.2.2.3 Conformance.8
4.2.3 Out of band emissions.8
4.2.3.1 Definition.8
4.2.3.2 Limits.8
4.2.3.3 Conformance.8
4.2.4 Unwanted emissions in the spurious domain.8
4.2.4.1 Definition.8
4.2.4.2 Limits.8
4.2.4.3 Conformance.8
4.2.5 Duty cycle.8
4.2.5.1 Definition.8
4.2.5.2 Limit.8
4.2.6 Receiver blocking or desensitization .9
4.2.6.1 Definition.9
4.2.6.2 Limit.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
5 Testing for compliance with technical requirements.9
5.1 Environmental conditions for testing .9
5.2 Interpretation of the measurement results .9
5.3 Essential radio test suites.10
5.3.1 Effective radiated power of the fundamental emission.10
5.3.2 Out of band emissions.10
5.3.3 Unwanted emissions in the spurious domain.10
5.3.4 Blocking or desensitization.10
5.3.5 Spurious radiation of receivers .10
5.3.6 Normal and extreme test-conditions .10
5.3.7 Test power source .10
5.3.8 Choice of samples for test suites.11
ETSI
4 ETSI EN 302 510-2 V1.1.1 (2007-07)
Annex A (normative): HS Requirements and conformance Test specifications Table (HS-
RTT).12
Annex B (informative): The EN title in the official languages .14
Annex C (informative): Bibliography.16
History .17

ETSI
5 ETSI EN 302 510-2 V1.1.1 (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 [4] (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 Council Directive on the approximation of the laws of
the Member States relating to electromagnetic compatibility ("the EMC Directive") (2004/108/EC [5] as amended) and
Directive 1999/5/EC [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").
The present document is part 2 of a multi-part deliverable covering inductively coupled Ultra Low Power Active
Medical Implant Membrane (ULP-AMI-M) devices in the frequency range 30 MHz to 37,5 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".
Technical specifications relevant to Directive 1999/5/EC [1] are given in annex A.

National transposition dates
Date of adoption of this EN: 15 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 302 510-2 V1.1.1 (2007-07)
1 Scope
The present document applies to Ultra Low Power-Active Medical Implants (ULP-AMI), Membrane Implants, and
accessories as described in Directive 90/385/EEC [6], operating in a Medical Implant Communications System (MICS)
in the frequency band 30 MHz to 37,5 MHz. An AIMD is regulated under the AIMD Directive 90/385/EEC [6]: radio
parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the
R&TTE Directive 1999/5/EC [1].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".
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] will 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] ETSI EN 302 510-1 (V1.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active
Medical Membrane Implants and Accessories; Part 1: Technical characteristics and test methods".
[3] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics Part 1".
[4] 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.
[5] Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on
the approximation of the laws of the Member States relating to electromagnetic compatibility and
repealing Directive 89/336/EEC (EMC Directive).
[6] 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 (AMD Directive).
ETSI
7 ETSI EN 302 510-2 V1.1.1 (2007-07)
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in the R&TTE Directive [1] and
EN 302 510-1 [2] apply.
3.2 Symbols
For the purposes of the present document, the symbols given in EN 302 510-1 [2] apply.
3.3 Abbreviations
For the purposes of the present document, the abbreviations given in EN 302 510-1 [2] apply.
4 Technical requirements 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 disturbance to other equipment and services and should not be disturbed by harmful
interference from other electronic devices. Transmitters and receivers may be individual or combination units.
4.2.1.2 Antennas
Equipment operating in the ULP-AMI band shall have an integral antenna, an external dedicated antenna or both. If
prov
...