SIST EN 301 839-2 V1.1.1:2003

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQHElectromagnetic 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 Directive33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipmentICS:Ta slovenski standard je istoveten z:EN 301 839-2 Version 1.1.1SIST EN 301 839-2 V1.1.1:2003en01-marec-2003SIST EN 301 839-2 V1.1.1:2003SLOVENSKI

ETSI EN 301 839-2 V1.1.1 (2002-06)Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 402 MHz to 405 MHzfor Ultra Low Power Active Medical Implants and Accessories;Part 2: Harmonized EN covering essential requirementsof article 3.2 of the R&TTE Directive

Reference REN/ERM-RP08-0404-2 Keywords radio, regulation, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE

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

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Contents Intellectual Property Rights................................................................................................................................5 Foreword.............................................................................................................................................................5 Introduction........................................................................................................................................................6 1 Scope........................................................................................................................................................8 2 References................................................................................................................................................8 3 Definitions and abbreviations...................................................................................................................9 3.1 Definitions..........................................................................................................................................................9 3.2 Abbreviations.....................................................................................................................................................9 4 Technical requirements specifications...................................................................................................10 4.1 Environmental profile.......................................................................................................................................10 4.1.1 General........................................................................................................................................................10 4.1.2 Temperature................................................................................................................................................10 4.1.3 Power supply voltages................................................................................................................................10 4.1.3.1 Mains voltage range..............................................................................................................................10 4.1.3.2 Regulated lead-acid battery power sources...........................................................................................10 4.1.3.3 Power sources using other types of batteries.........................................................................................11 4.1.3.4 Other power sources..............................................................................................................................11 4.2 Conformance requirements..............................................................................................................................11 4.2.1 Mechanical and electrical design................................................................................................................11 4.2.1.1 General..................................................................................................................................................11 4.2.1.2 Antennas...............................................................................................................................................11 4.2.1.3 Controls.................................................................................................................................................11 4.2.1.4 Transmitter shut-off facility..................................................................................................................11 4.2.2 Frequency error...........................................................................................................................................12 4.2.2.1 Definition..............................................................................................................................................12 4.2.2.2 Limits....................................................................................................................................................12 4.2.2.3 Conformance.........................................................................................................................................12 4.2.3 Emission bandwidth....................................................................................................................................12 4.2.3.1 Definition..............................................................................................................................................12 4.2.3.2 Limits....................................................................................................................................................12 4.2.3.3 Conformance.........................................................................................................................................12 4.2.4 Effective radiated power of the fundamental emission...............................................................................12 4.2.4.1 Definition..............................................................................................................................................12 4.2.4.2 Limits....................................................................................................................................................12 4.2.4.3 Conformance.........................................................................................................................................12 4.2.5 Spurious emissions.....................................................................................................................................12 4.2.5.1 Definition..............................................................................................................................................12 4.2.5.2 Limits....................................................................................................................................................12 4.2.5.3 Conformance.........................................................................................................................................12 4.2.6 Frequency stability under low voltage conditions......................................................................................13 4.2.6.1 Definition..............................................................................................................................................13 4.2.6.2 Limits....................................................................................................................................................13 4.2.6.3 Conformance.........................................................................................................................................13 4.2.7 Spurious radiation of receivers...................................................................................................................13 4.2.7.1 Definition..............................................................................................................................................13 4.2.7.2 Limits....................................................................................................................................................13 4.2.7.3 Conformance.........................................................................................................................................13 4.2.8 Monitoring system......................................................................................................................................13 4.2.8.1 Definition..............................................................................................................................................13 4.2.8.2 Limits....................................................................................................................................................13 4.2.8.3 Conformance.........................................................................................................................................13 5 Testing for compliance with technical requirements..............................................................................13 5.1 Environmental conditions for testing...............................................................................................................13 SIST EN 301 839-2 V1.1.1:2003

5.2 Interpretation of the measurement results........................................................................................................14 5.3 Essential radio test suites..................................................................................................................................14 5.3.1 Frequency error...........................................................................................................................................14 5.3.2 Emission bandwidth....................................................................................................................................14 5.3.3 Effective radiated power of the fundamental emission...............................................................................14 5.3.4 Spurious emissions.....................................................................................................................................14 5.3.5 Frequency stability under low voltage conditions......................................................................................15 5.3.6 Spurious radiation of receivers...................................................................................................................15 5.3.7 Monitoring system......................................................................................................................................15 Annex A (normative): The EN Requirements Table (EN-RT)........................................................16 Annex B (normative): The EN title in the official languages...........................................................17 Annex C (informative): Bibliography...................................................................................................18 History..............................................................................................................................................................19

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 has been produced by ETSI in response to a mandate from the European Commission issued under Council Directive 98/34/EC [7] (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 [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") [1]. The present document is part 2 of a multi-part deliverable covering Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories, as identified below: Part 1: "Technical characteristics, including electromagnetic compatibility requirements, 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: 7 June 2002 Date of latest announcement of this EN (doa): 30 September 2002 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 March 2003 Date of withdrawal of any conflicting National Standard (dow): 31 March 2004

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.

- If needed, new standards for human exposure to Electromagnetic Fields, - if needed, new standards for acoustic safety Use of spectrum * If needed Scoped by

class or type Scoped by frequency and/or equipment type Disability* Privacy* Fraud* No harm to the network* Emergency* Interworking via

the network* Interworking with the network Non-radio Radio (RE) Non-TTE TTE 3.1b 3.2 3.3c 3.3b 3.3a 3.3d 3.3e 3.3f Radio Product EMC EN 301 489 multi-part EMC standard Generic and product standards also notified under EMC Directive Standards also notified under LV Directive 3.1a New radio harmonized standards Spectrum EMC Safety

Figure 1: Modular structure for the various standards used under the R&TTE Directive SIST EN 301 839-2 V1.1.1:2003

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 whose scope is likely to be specified by function or interface type. The vertical boxes show the standards under article 3.2 for the use of the radio spectrum by radio equipment. The scopes of these standards are specified either by frequency (normally in the case where frequency bands are harmonized) or by radio equipment type. For article 3.1b the diagram shows EN 301 489, the multi-part product EMC standard for radio used under the EMC Directive [2].

For article 3.1a the diagram shows the existing safety standards currently used under the LV Directive [3] and new standards covering human exposure to electromagnetic fields. New standards covering acoustic safety may also be required. The bottom of the figure shows the relationship of the standards to radio equipment and telecommunications terminal equipment. A particular equipment may be radio equipment, telecommunications terminal equipment or both. A radio spectrum standard will apply if it is radio equipment. An article 3.3 standard will apply as well only if the relevant essential requirement under the R&TTE Directive [1] is adopted by the Commission and if the equipment in question is covered by the scope of the corresponding standard. Thus, depending on the nature of the equipment, the essential requirements under the R&TTE Directive [1] may be covered in a set of standards. The modularity principle has been taken because: •

it minimizes the number of standards needed. Because equipment may, in fact, have multiple interfaces and functions it is not practicable to produce a single standard for each possible combination of functions that may occur in an equipment; •

it provides scope for standards to be added: - under article 3.2 when new frequency bands are agreed; or - under article 3.3 should the Commission take the necessary decisions;

it clarifies, simplifies and promotes the usage of Harmonized Standards as the relevant means of conformity assessment. SIST EN 301 839-2 V1.1.1:2003

1 Scope The present document applies to Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories as described in Directive 90/385/EEC [4], operating in a Medical Implant Communications System (MICS) in the frequency band 402 MHz to 405 MHz.

NOTE 1: The present document applies to operation in the band 402 MHz to 405 MHz only; devices that can also operate in spectrum outside this band should also meet any applicable requirements for operation in such bands. 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 2: 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. [1] Directive 1999/5/EC of the European