SIST EN 302 510-2 V1.1.1:2007
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
- 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
- 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
SIST EN 302 510-2 V1.1.1:2007 is the SIST adoption of ETSI EN 302 510-2 V1.1.1 for radio equipment in the 30 MHz to 37,5 MHz band used by Ultra Low Power Active Medical Membrane Implants and accessories. It specifies the radio-spectrum and electromagnetic compatibility conditions used to show conformity with Article 3.2 of the R&TTE Directive, mainly for manufacturers, test laboratories, and conformity assessors.
What does SIST EN 302 510-2 V1.1.1:2007 specify?
SIST EN 302 510-2 V1.1.1:2007 applies to Ultra Low Power-Active Medical Implants (ULP-AMI), Membrane Implants, and accessories operating in a Medical Implant Communications System (MICS) in the frequency band 30 MHz to 37,5 MHz. The document focuses on avoiding harmful interference by setting the radio requirements needed for presumption of conformity under Article 3.2 of the R&TTE Directive.
The standard is the second part of a multi-part deliverable. Part 1 contains the technical characteristics and test methods, while Part 2 gives the harmonized requirements for Article 3.2.
| Annex | What it covers |
|---|---|
| Annex A | HS Requirements and conformance Test specifications Table (HS-RTT) |
| Annex B | The EN title in the official languages |
| Annex C | Bibliography |
What are the key requirements of SIST EN 302 510-2 V1.1.1:2007?
SIST EN 302 510-2 V1.1.1:2007 sets design, emission, receiver, and test conditions that a product must meet within its declared operational environmental profile. In practice, this means the manufacturer must declare the operating environment and demonstrate that the equipment stays compliant across that declared range.
Design and antenna requirements
Clause 4.2.1 requires sound engineering practice, with the aim of limiting harmful disturbance to other equipment and services. For equipment in the ULP-AMI band, the antenna must be integral, dedicated external, or both, and any external antenna connector must be unique so that only the manufacturer’s dedicated antenna can be used. Controls that could increase disturbance if misadjusted must not be easily accessible, and any transmitter shut-off or battery-saving feature that interferes with testing must be able to be disabled for test purposes.
Emissions and receiver performance
Clause 4.2.2 covers the maximum effective radiated power of the fundamental emission, clause 4.2.3 covers out of band emissions, and clause 4.2.4 covers unwanted emissions in the spurious domain. Clause 4.2.5 sets the duty cycle limit, while clauses 4.2.6 and 4.2.7 cover receiver blocking or desensitization and spurious radiation of receivers. These are the core spectrum-shaping requirements, so they determine whether the device radiates only as intended and whether its receiver can tolerate interference.
Compliance testing and measurement
Clause 5 requires testing at representative points within the declared environmental profile and, where performance varies with conditions, under enough different conditions to support confidence in compliance. Clause 5.2 requires the test report to include measurement uncertainty, with uncertainty calculated in line with ETSI TR 100 028. Clause 5.3 lists the essential radio test suites for fundamental emission power, out of band emissions, spurious emissions, blocking or desensitization, and receiver spurious radiation.
Test suite mapping
Annex A ties each essential requirement to its clause and test specification. It shows which items are unconditional and which have an associated essential test, which helps a manufacturer or lab see what must be demonstrated for the presumption of conformity.
What terms does SIST EN 302 510-2 V1.1.1:2007 define?
- ULP-AMI - Ultra Low Power-Active Medical Implant, used here for the radio parts of active implantable medical devices.
- MICS - Medical Implant Communications System, the radio system in which the devices operate in this band.
- AIMD - Active implantable medical device, the medical device class referenced by Directive 90/385/EEC.
- R&TTE Directive - Directive 1999/5/EC, the legal framework this standard supports for radio equipment.
- HS-RTT - Harmonized Standard Requirements and conformance Test specifications Table, the annex that maps requirements to tests.
- EUT - Equipment under test, the sample being measured in the compliance test suites.
Who uses SIST EN 302 510-2 V1.1.1:2007?
SIST EN 302 510-2 V1.1.1:2007 is used by manufacturers of ULP-AMI, membrane implants, and associated peripheral radio devices when they design the radio part and prepare technical documentation. Test laboratories use it to run the required emission and receiver tests, including the declared environmental conditions and measurement uncertainty reporting.
Regulatory and conformity assessment teams use it to check whether a device can support presumption of conformity with Article 3.2 of the R&TTE Directive. Quality managers and buyers use it to verify that a product has been assessed against the right radio standard for this medical implant band.
Which standards are used with SIST EN 302 510-2 V1.1.1:2007?
- Directive 1999/5/EC (R&TTE Directive) - the legal basis for the essential radio requirement addressed by this standard.
- ETSI EN 302 510-1 (V1.1.1) - provides the shared technical characteristics, test methods, definitions, limits, and the clauses referenced throughout Part 2.
- ETSI TR 100 028 (V1.3.1) - provides the approach for calculating measurement uncertainty.
- Directive 90/385/EEC (AMD Directive) - frames the active implantable medical device context for the devices covered.
- Directive 98/34/EC and Directive 2004/108/EC - appear in the foreword as part of the standard’s regulatory background.
What does the SIST EN 302 510-2 V1.1.1:2007 document contain?
SIST EN 302 510-2 V1.1.1:2007 contains the scope, normative references, definitions and abbreviations, technical requirements, and compliance testing clauses. It also includes the essential requirement and test mapping in Annex A, which is the most practical cross-reference for conformity work.
Clause 4 gives the required performance areas, while Clause 5 gives the testing framework, including environmental conditions, measurement uncertainty, test suite selection, and the link back to EN 302 510-1. The document also contains Table 1 for maximum measurement uncertainty and the multilingual title list in Annex B, plus a bibliography in Annex C.
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Frequently Asked Questions
SIST EN 302 510-2 V1.1.1:2007 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "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". This standard covers: 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.
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.
SIST EN 302 510-2 V1.1.1:2007 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics; 33.060.20 - Receiving and transmitting equipment; 33.100.01 - Electromagnetic compatibility in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 302 510-2 V1.1.1:2007 is associated with the following European legislation: EU Directives/Regulations: 2005-01-1864, 2014/53/EU, TRRTP124. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 302 510-2 V1.1.1:2007 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2007
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5DGLMVNDRSUHPDYIUHNYHQþQHPREPRþMXRG0+]GR0+]]DDNWLYQH
PHPEUDQVNHPHGLFLQVNHYVDGNHXOWUDPDMKQLKPRþLLQSULERUGHO
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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
...