SIST EN 302 195-2 V1.1.1:2004

Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Develop specific standard for Ultra Low Power Active Medical Implants operating in the frequency range of 9kHz to 315kHz.

Elektromagnetna združljivost (EMC) in zadeve v zvezi z radijskim spektrom (ERM) - Radijska oprema v frekvenčnem območju od 9 kHz do 315 kHz za aktivne medicinske vsadke ultra majhnih moči (ULP-AMI) in pribor - 2. del: Harmonizirani evropski standard (EN), ki zajema bistvene zahteve člena 3.2 direktive o radijski in telekomunikacijski terminalski opremi (R&TTE)

General Information

• Status: Published
• Publication Date: 30-Sep-2004
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: RES - Radio equipment and systems
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Oct-2004
• Due Date: 01-Oct-2004
• Completion Date: 01-Oct-2004
• Directive: 1999/5/EC - Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity
• Directive: TRRTP124 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-4)
• Mandate: M/284
• Ref Project: ETSI EN 302 195-2 V1.1.1 (2004-01) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 302 195-2 V1.1.1:2004
01-oktober-2004
(OHNWURPDJQHWQD]GUXåOMLYRVW(0&LQ]DGHYHY]YH]L]UDGLMVNLPVSHNWURP(50
5DGLMVNDRSUHPDYIUHNYHQþQHPREPRþMXRGN+]GRN+]]DDNWLYQH
PHGLFLQVNHYVDGNHXOWUDPDMKQLKPRþL8/3$0,LQSULERUGHO+DUPRQL]LUDQL
HYURSVNLVWDQGDUG(1NL]DMHPDELVWYHQH]DKWHYHþOHQDGLUHNWLYHRUDGLMVNLLQ
WHOHNRPXQLNDFLMVNLWHUPLQDOVNLRSUHPL5 77(
Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in
the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP
-AMI) 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 302 195-2 Version 1.1.1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN 302 195-2 V1.1.1:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 302 195-2 V1.1.1:2004

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SIST EN 302 195-2 V1.1.1:2004

ETSI EN 302 195-2 V1.1.1 (2004-03)
Candidate Harmonized European Standard (Telecommunications series)

Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Radio equipment in the frequency range 9 kHz to 315 kHz
for Ultra Low Power Active Medical Implants (ULP-AMI)
and accessories;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive

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SIST EN 302 195-2 V1.1.1:2004
 2 ETSI EN 302 195-2 V1.1.1 (2004-03)



Reference
DEN/ERM-TG30-001-2
Keywords
health, inductive, magnetic, mobile, radio,
regulation, short range, SRD, testing
ETSI
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SIST EN 302 195-2 V1.1.1:2004
 3 ETSI EN 302 195-2 V1.1.1 (2004-03)
Contents
Intellectual Property Rights.4
Foreword.4
Introduction .5
1 Scope.7
2 References.8
3 Definitions, symbols and abbreviations .8
3.1 Definitions.8
3.2 Symbols.8
3.3 Abbreviations.8
4 Technical requirements specifications.9
4.1 Environmental profile.9
4.2 Transmitter requirements.9
4.2.1 Radiated field strength or power.9
4.2.1.1 Radiated H-field.9
4.2.1.2 Radiated E-field.9
4.2.2 Permitted range of modulation bandwidth.9
4.2.3 Spurious emissions.9
4.2.4 Duty cycle.9
4.3 Receiver requirements.9
4.3.1 Blocking or desensitization.9
4.3.2 Receiver spurious radiations.10
5 Testing for compliance with technical requirements.10
5.1 Essential radio test suites.10
5.1.1 Environmental conditions for testing.10
5.1.1.1 Normal and extreme test-conditions.10
5.1.1.2 Test power source .10
5.1.2 Choice of samples for test suites.10
5.1.3 Transmitter test suites.10
5.1.3.1 Effective radiated H-field, carrier current or radiated power .10
5.1.3.2 Permitted frequency range of the modulation bandwidth .10
5.1.3.3 Spurious emissions.10
5.1.4 Receiver test suites.11
5.1.4.1 Blocking or desensitization .11
5.1.4.2 Spurious radiation.11
6 Interpretation of measurement results .11
Annex A (informative): Bibliography.12
Annex B (informative): The EN title in the official languages .13
History .14

ETSI

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SIST EN 302 195-2 V1.1.1:2004
 4 ETSI EN 302 195-2 V1.1.1 (2004-03)
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 Candidate Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical
Committee Electromagnetic compatibility and Radio spectrum Matters (ERM).
The present document is part 2 of a multi-part deliverable covering Radio equipment in the frequency range 9 kHz to
315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, 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".
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC [5] (as amended) laying down a procedure for the provision of information in the
field of technical standards and regulations.
The present document is intended to become a Harmonized Standard, the reference of which will be published in the
Official Journal of the European Communities referencing the Directive 1999/5/EC of the European Parliament and of
the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual
recognition of their conformity ("the R&TTE Directive").

National transposition dates
Date of adoption of this EN: 12 March 2004
Date of latest announcement of this EN (doa): 30 June 2004
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 December 2004
Date of withdrawal of any conflicting National Standard (dow): 31 December 2005

ETSI

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SIST EN 302 195-2 V1.1.1:2004
 5 ETSI EN 302 195-2 V1.1.1 (2004-03)
Introduction
The present document is part of a set of standards designed to fit in a modular structure to cover all radio and
telecommunications terminal equipment under the R&TTE Directive [1]. Each standard is a module in the structure.
The modular structure is shown in figure 1.

Disability*
3.3f
Emergency*
3.3e
Fraud*
3.3d
3.3c
Privacy*
No harm to the network*
3.3b
* If needed
Scoped by
Interworking via the network*
equipment
3.3a class or type
Interworking with the network
Use of spectrum
3.2
New radio harmonized standards
Spectrum
Scoped by frequency and/or equipment type
Radio Product EMC
EN 301 489 multi-part EMC standard
3.1b
EMC
Generic and product standards also notified under EMC Directive
- If needed, new standards for human exposure to
Electromagnetic Fields,
- if needed, new standards for acoustic safety
3.1a
Standards also notified under LV Directive
Safety
Non-radio Radio (RE)
TTE Non-TTE

Figure 1: Modular structure for the various standards used under the R&TTE Directive [1]
ETSI

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SIST EN 302 195-2 V1.1.1:2004
 6 ETSI EN 302 195-2 V1.1.1 (2004-03)
The left hand edge of the figure 1 shows the different clauses of article 3 of the R&TTE Directive [1].
For article 3.3 various horizontal boxes are shown. Dotted lines indicate that at the time of publication of the present
document essential requirements in these areas have to be adopted by the Commission. If such essential requirements
are adopted, and as far and as long as they are applicable, they will justify individual standards w
...