SIST EN 301 839-2 V1.3.1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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 Directive33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 301 839-2 Version 1.3.1SIST EN 301 839-2 V1.3.1:2009en01-december-2009SIST EN 301 839-2 V1.3.1:2009SLOVENSKI

ETSI EN 301 839-2 V1.3.1 (2009-10)Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand 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 requirementsof article 3.2 of the R&TTE Directive SIST EN 301 839-2 V1.3.1:2009

Reference REN/ERM-TG30-263-2 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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DECTTM, PLUGTESTSTM, UMTSTM, TIPHONTM, the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. LTE™ is a Trade Mark of ETSI currently being registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 301 839-2 V1.3.1:2009

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 3 Contents Intellectual Property Rights ................................................................................................................................ 5 Foreword ............................................................................................................................................................. 5 1 Scope ........................................................................................................................................................ 6 2 References ................................................................................................................................................ 6 2.1 Normative references ......................................................................................................................................... 7 2.2 Informative references ........................................................................................................................................ 7 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 ................................................................................................................................ 8 4.2.1 Mechanical and electrical design .................................................................................................................. 8 4.2.1.1 General .................................................................................................................................................... 8 4.2.1.2 Antennas ................................................................................................................................................. 8 4.2.1.3 Controls ................................................................................................................................................... 8 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 ................................................................................. 9 4.2.4.1 Definition ................................................................................................................................................ 9 4.2.4.2 Limits ...................................................................................................................................................... 9 4.2.4.3 Conformance ........................................................................................................................................... 9 4.2.5 Spurious emissions of transmitter ................................................................................................................. 9 4.2.5.1 Definition ................................................................................................................................................ 9 4.2.5.2 Limits ...................................................................................................................................................... 9 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 ......................................................................................................................................... 10 4.2.8.1 LBT/AFA spectrum access ................................................................................................................... 10 4.2.8.1.1 Definition......................................................................................................................................... 10 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 .............................................................................. 11 5.1 Environmental conditions for testing ............................................................................................................... 11 5.2 Interpretation of the measurement results ........................................................................................................ 11 5.3 Essential radio test suites .................................................................................................................................. 11 SIST EN 301 839-2 V1.3.1:2009

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 4 5.3.1 Frequency error ........................................................................................................................................... 11 5.3.2 Emission bandwidth .................................................................................................................................... 12 5.3.3 Effective radiated power of the fundamental emission ............................................................................... 12 5.3.4 Spurious emissions of transmitter ............................................................................................................... 12 5.3.5 Frequency stability under low voltage conditions ...................................................................................... 12 5.3.6 Spurious radiation of receivers ................................................................................................................... 12 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 ................................................................................................... 16 History .............................................................................................................................................................. 17

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 5 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) [i.3] 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 [i.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") [i.1]. Technical specifications relevant to Directive 1999/5/EC [i.1] 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: 28 September 2009 Date of latest announcement of this EN (doa): 31 December 2009 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

30 June 2010 Date of withdrawal of any conflicting National Standard (dow): 30 June 2011

ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 6 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 in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and

Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) service frequency bands Transmit Ultra Low Power Active Medical Implants

(ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical Implants

The present document is intended to cover the provisions of Directive 1999/5/EC [i.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 [i.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 [i.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 [i.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 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. • Non-specific reference may be made only to a complete document or a part thereof and only in the following cases: - if it is accepted that it will be possible to use all future changes of the referenced document for the purposes of the referring document; - for informative references. Referenced documents which are not found to be publicly