ETSI EN 301 559-2 V1.1.2 (2012-06)

Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive

DEN/ERM-TG30-301

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Naprave kratkega dosega (SRD) - Aktivni medicinski vsadki majhnih moči (LP-AMI), ki delujejo v frekvenčnem območju od 2483,5 MHz do 2500 MHz - 2. del: Harmonizirani EN, ki zajema bistvene zahteve člena 3.2 direktive R&TTE

Ta dokument zajema zahtevane karakteristike aktivnih medicinskih vsadkov majhnih moči (LP-AMI) in pripadajočih perifernih naprav (LP-AMI-P) za uporabo v komunikacijskem sistemu aktivnih medicinskih vsadkov (AMICS), ki se štejejo za nujne za učinkovito uporabo razpoložljivega spektra in so v interesu bolnikov z vsadki. Specifikacije iz tega dokumenta so bile pripravljene za varovanje zdravja in varnosti bolnikov, ki uporabljajo te naprave po zdravnikovih navodilih. Posebno pomembne so zahteve za spremljanje spektra in dostop, ki so namenjene za pomembno zmanjšanje morebitne možnosti motenja komunikacijskega sistema aktivnih medicinskih vsadkov, ki deluje v pasu, ali motenja med komunikacijskim sistemom aktivnih medicinskih vsadkov in drugimi primarnimi ali sekundarnimi uporabniki pasu. Aktivne medicinske vsadke ureja Direktiva 90/385/EGS [i.3] o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev; radijske dele, ki jih zajema (v tem besedilu: medicinski vsadki majhnih moči in pripadajoče periferne naprave), ureja Direktiva 1999/5/ES [i.1] (direktiva R&TTE). Ta dokument naj bi se uporabljal za delovanje v pasu 2483,5 MHz do 2500 MHz; pripomočki, ki lahko delujejo tudi v spektru zunaj tega pasu, morajo prav tako izpolnjevati morebitne veljavne zahteve za delovanje v teh pasovih. Ta dokument zajema tehnične karakteristike za radijsko opremo za medicinske vsadke majhnih moči in pripadajoče periferne radijske opreme, ki je obravnavana tudi v standardu CEPT/ERC/REC 70-03 [i.2] in delu f dodatka 12 k navedenemu dokumentu. Ne vključuje nujno vseh karakteristik, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno najboljšega možnega delovanja. Uporablja se za medicinske vsadke majhnih moči in pripadajoče periferne naprave, ki delujejo v pasu od 2483,5 MHz to 2500 MHz:
za daljinsko vodenje in telemetrijo med medicinskim vsadkom majhnih moči in pripadajočo periferno napravo;
za daljinsko vodenje in telemetrijo med medicinskim vsadkom majhnih moči in drugim medicinskim vsadkom majhnih moči;
z vgrajeno anteno ali brez nje in/ali
z antensko povezavo samo zaradi povezave z ustrezno anteno.
Ta dokument zajema zahtevane karakteristike, ki jih morajo izpolnjevati radijske naprave v komunikacijskem sistemu aktivnih medicinskih vsadkov za učinkovito uporabo razpoložljivega spektra za prenos podatkov, ki se uporabljajo za postavitev diagnoze in zdravljenje posameznikov z različnimi boleznimi. Posebno pomembne so zahteve za spremljanje spektra in dostop (navedene pred protokolom govora), ki so namenjene za pomembno zmanjšanje morebitne možnosti motenja
komunikacijskega sistema aktivnih medicinskih vsadkov, ki deluje v pasu, ali motenja med komunikacijskim sistemom aktivnih medicinskih vsadkov in primarnimi uporabniki pasu. Ta dokument je standard za specifičen proizvod, ki se uporablja za oddajnike majhnih moči, ki so del sistema, ki se uporablja v komunikacijskem sistemu aktivnih medicinskih vsadkov, ki deluje v spektru v frekvenčnem pasu 2483,5 MHz do 2500 MHz. Poleg tega dokumenta se za opremo v področju uporabe tega dokumenta uporabljajo tudi drugi standardi EN, ki določajo tehnične zahteve v zvezi z bistvenimi zahtevami iz drugih delov člena 3 direktive R&TTE [i.1].

General Information

• Status: Published
• Publication Date: 22-Oct-2012
• Technical Committee: ERM TG30 - ERM Wireless Medical Devices
• Current Stage: 12 - Completion
• Due Date: 02-Jul-2012
• Completion Date: 19-Jun-2012
• Mandate: M/284
• Ref Project: SIST EN 301 559-2 V1.1.2:2012 - Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.577(Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.01Radijske komunikacije na splošnoRadiocommunications in generalICS:Ta slovenski standard je istoveten z:EN 301 559-2 Version 1.1.2SIST EN 301 559-2 V1.1.2:2012en01-september-2012SIST EN 301 559-2 V1.1.2:2012SLOVENSKI
STANDARD



SIST EN 301 559-2 V1.1.2:2012



ETSI EN 301 559-2 V1.1.2 (2012-06) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
Harmonized European Standard SIST EN 301 559-2 V1.1.2:2012



ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 2
Reference DEN/ERM-TG30-301 Keywords EMC, health, radio, regulation, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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© European Telecommunications Standards Institute 2012. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are Trade Marks of ETSI 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 301 559-2 V1.1.2:2012



ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 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 Automatic 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 isotropic 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 Transmitter unwanted s emissions . 9 4.2.5.1 Out-of-band emissions . 9 4.2.5.1.1 Definition. 9 4.2.5.1.2 Limits . 9 4.2.5.2 Spurious emissions . 9 4.2.5.2.1 Definition. 9 4.2.5.2.2 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 . 10 4.2.7.1 Definition . 10 4.2.7.2 Limits . 10 4.2.7.3 Conformance . 10 4.2.8 Spectrum access . 10 4.2.8.1 Spectrum access . 10 4.2.8.1.1 Definition. 10 4.2.8.1.2 Limits . 10 4.2.8.1.3 Conformance . 10 5 Testing for compliance with technical requirements . 10 5.1 Environmental conditions for testing . 10 5.2 Interpretation of the measurement results . 10 SIST EN 301 559-2 V1.1.2:2012



ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 4 5.3 Essential radio test suites . 11 5.3.1 Frequency error . 11 5.3.2 Emission bandwidth . 11 5.3.3 Effective isotropic radiated power of the fundamental emission . 11 5.3.4 Unwanted emissions . 11 5.3.4.1 Out-of-band emissions . 11 5.3.4.2 Transmitter spurious emissions . 12 5.3.5 Frequency stability under low voltage conditions . 12 5.3.6 Receiver spurious emissions . 12 5.3.7 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): Void . 15 Annex C (informative): Bibliography . 16 History . 17
SIST EN 301 559-2 V1.1.2:2012



ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 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://ipr.etsi.org). 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 (EN) 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 Directive 98/34/EC [i.5] as amended by Directive 98/48/EC [i.6]. The title and reference to the present document are intended to be included in the publication in the Official Journal of the European Union of titles and references of Harmonized Standard under the Directive 1999/5/EC [i.1]. See article 5.1 of Directive 1999/5/EC [i.1] for information on presumption of conformity and Harmonised Standards or parts thereof the references of which have been published in the Official Journal of the European Union. The requirements relevant to Directive 1999/5/EC [i.1] are summarised in annex A. For non EU countries the present document may be used for regulatory purposes. The present document is part 2 of a multi-part deliverable covering Low Power Active Medical Implants (LP-AMI), Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz as described in the systems reference document for the equipment, TR 102 655 [i.4]. Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 18 June 2012 Date of latest announcement of this EN (doa): 30 September 2012 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2013 Date of withdrawal of any conflicting National Standard (dow): 31 March 2014
SIST EN 301 559-2 V1.1.2:2012



ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 6 1 Scope The present document covers, for Low Power Active Medical Implants (LP-AMI), and associated Peripherals (LP-AMI-P) used in an Active Medical Implant Communications System (AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential between AMICS operating in the band or between AMICS and other primary or secondary users of the band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.3] radio parts contained therein (referred to herein as LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC [i.1] (R&TTE Directive). It is intended that the present document applies to operation in the band 2 483,5 MHz to 2 500 MHz that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for LP-AMI and associated peripherals radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 band f to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. It applies to LP-AMI and LP-AMI_P operating in the band 2 483,5 MHz to 2 500 MHz: • for telecommand and telemetry between LP-AMI and LP-AMI-P; • for telecommand and telemetry between LP-AMI to another LP-AMI; • with or without an integral antenna; and/or • with an antenna connection provided only for the purpose of connecting a dedicated antenna. The present document contains required characteristics considered necessary for the radio devices used in AMICS to meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and delivering therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between AMICS operating in the band or between an AMICS and the primary users of the band.
The present document is a specific product standard applicable to low power transmitters that are part of a system used in the AMICS operating in spectrum within the frequency band 2 483,5 MHz to 2 500 MHz.
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