ETSI EN 301 559-1 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 1: Technical characteristics and test methods
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 1: Technical characteristics and test methods
DEN/ERM-TG30-300
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 - 1. del: Tehnične karakteristike in preskusne metode
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. Ta dokument zajema tudi možnost nizkega obratovalnega ciklusa/dostopa z nizko porabo v frekvenčnem pasu. Aktivne medicinske vsadke ureja Direktiva 90/385/EGS [i.7] 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 do/od medicinskega vsadka majhnih moči v bolnikovem telesu ali pripadajoče periferne naprave ali med njima;
za daljinsko vodenje in telemetrijo do/od medicinskega vsadka majhnih moči do drugega medicinskega vsadka majhnih moči v človeškem telesu;
z vgrajeno anteno ali brez nje in/ali
z antensko povezavo samo zaradi povezave z zunanjo ustrezno anteno. Ta dokument zajema zahteve za elektromagnetno sevanje nad 30 MHz.
General Information
Standards Content (Sample)
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) - Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.01Radijske komunikacije na splošnoRadiocommunications in generalICS:Ta slovenski standard je istoveten z:EN 301 559-1 Version 1.1.2SIST EN 301 559-1 V1.1.2:2012en01-september-2012SIST EN 301 559-1 V1.1.2:2012SLOVENSKI
STANDARD
SIST EN 301 559-1 V1.1.2:2012
ETSI EN 301 559-1 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 1: Technical characteristics and test methods
European Standard SIST EN 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 2
Reference DEN/ERM-TG30-300 Keywords EMC, health, radio, 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 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Introduction . 6 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 11 3.3 Abbreviations . 12 4 Technical requirements and specifications . 12 4.1 General requirements . 12 4.1.1 Transmitter requirements . 12 4.1.2 Receiver requirements . 12 4.2 Presentation of equipment for testing purposes . 13 4.2.1 Choice of model for testing . 13 4.2.2 Spurious emission testing for composite equipment . 13 4.2.3 Testing of equipment with alternative power levels . 13 4.2.4 Presentation of equipment that does not have an external RF connector (integral antenna equipment) . 14 4.2.4.1 Equipment with an internal permanent or temporary antenna connector . 14 4.2.4.2 Equipment with a temporary antenna connector . 14 4.2.4.3 Equipment intended to be implanted in a human body . 14 4.3 Mechanical and electrical design . 14 4.3.1 General . 14 4.3.2 Controls . 14 4.3.3 Transmitter shut-off facility . 14 4.3.4 Marking . 14 4.3.5 Equipment identification . 14 4.4 Declarations by the Applicant . 15 4.5 Auxiliary test equipment . 15 4.6 Interpretation of the measurement results . 15 5 Test conditions, power sources and ambient temperatures . 15 5.1 Normal and extreme test conditions . 15 5.2 Test power source . 15 5.2.1 External test power source . 15 5.2.2 Internal test power source . 16 5.3 Normal test conditions . 16 5.3.1 Normal temperature and humidity . 16 5.3.2 Normal test power source . 16 5.3.2.1 Mains voltage . 16 5.3.2.2 Power sources . 16 5.4 Extreme test conditions . 17 5.4.1 Extreme temperatures . 17 5.4.1.1 Procedure for tests at extreme temperatures . 17 5.4.1.1.1 Procedure for equipment designed for continuous operation . 17 5.4.1.1.2 Procedure for equipment designed for intermittent operation . 17 5.4.1.2 Extreme temperature ranges . 17 5.4.2 Extreme test source voltages . 18 5.4.2.1 Mains voltage . 18 5.4.2.2 Power sources . 18 6 General conditions . 18 SIST EN 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 4 6.1 Normal test signals and test modulation . 18 6.1.1 Normal modulation test signals for data . 19 6.2 Antennas . 19 6.3 Artificial antenna . 19 6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector . 19 6.4 Test fixture for LP-AMI-P. 19 6.5 Test fixture for LP-AMI . 20 6.6 Test sites and general arrangements for radiated measurements . 20 6.7 Modes of operation of the transmitter . 20 6.8 Measuring receiver . 20 7 Measurement uncertainty . 21 8 Methods of measurement and limits for transmitter parameters . 22 8.1 Frequency error . 22 8.1.1 Definition . 22 8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23 8.1.1.2 Method of measurement for systems with a modulated output frequency . 23 8.1.2 Limit . 23 8.2 Emission bandwidth measurement . 23 8.2.1 Definition . 23 8.2.1.1 Method of measurement . 23 8.2.2 Limits . 24 8.3 Effective isotropic radiated power of the fundamental emission . 24 8.3.1 Definition . 24 8.3.1.1 Methods of measurement . 24 8.3.2 Limits . 25 8.4 Spurious emissions . 25 8.4.1 Definition . 25 8.4.1.1 Method of measuring the effective radiated power of spurious emissions. 25 8.4.2 Limits . 27 8.5 Out-of-band emissions . 27 8.5.1 Definition . 27 8.5.2 Methods of measurement . 27 8.5.3 Limits . 27 8.6 Frequency stability under low voltage conditions . 28 8.6.1 Definition . 28 8.6.1.1 Method of measurement . 28 8.6.2 Limits . 28 8.7 LP-AMI-P with restricted duty cycle . 28 8.7.1 Definitions . 28 8.7.2 Declaration of Duty Cycle . 28 8.7.3 Limit for duty cycle and maximum number of transmissions . 29 9 Methods of measurement and limits for receiver parameters . 29 9.1 Spurious radiation. 29 9.1.1 Definition . 29 9.1.1.1 Method of measuring the effective radiated power of spurious radiations. 29 9.1.2 Limits . 30 10 Requirements and Measuring Methods for Monitoring Systems . 31 10.1 Purpose . 31 10.2 General Remarks on the Measurement Configuration . 31 10.3 LBT threshold power level . 32 10.3.1 Measurement method using out-of-operating-region disturbance . 32 10.3.2 Measurement method using frequency administration commands . 33 10.3.3 Measurement method for LBT operation under interference condition . 33 10.3.4 Results based on above test method . 33 10.3.5 Limit . 33 10.4 Monitoring system bandwidth . 33 10.4.1 Measurement method using out-of-operating-region disturbance . 34 10.4.2 Measurement method using frequency administration commands . 34 10.4.3 Results based on above test method . 34 SIST EN 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 5 10.5 Monitoring system scan cycle time and minimum channel monitoring period . 35 10.5.1 Measurement method using out-of-operating-region disturbance . 35 10.5.1.1 Scan cycle time . 35 10.5.1.2 Minimum channel monitoring period . 35 10.5.2 Measurement method using frequency administration commands . 35 10.5.3 Results based on above test method . 36 10.5.3.1 Scan cycle time . 36 10.5.3.2 Minimum Channel Monitoring Period . 36 10.6 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 36 10.6.1 Access based on lowest ambient level above PTh using out-of-operating-region disturbance . 36 10.6.2 Access based on lowest ambient level above PTh using frequency administration commands . 37 10.6.3 Results based on above test method . 37 10.7 Discontinuation of AMICS session if a silent period greater than or equal to 5 seconds occurs . 37 10.7.1 Measurement method . 37 10.7.2 Results based on above test method . 37 10.8 Use of pre-scanned alternative channel . 38 10.8.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38 10.8.2 Measurement method for alternate channel selection using frequency administration commands . 39 10.8.3 Results based on above test method . 39 Annex A (normative): Radiated measurements . 41 A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 41 A.1.1 Outdoor test site . 41 A.1.1.1 Standard position . 41 A.1.1.2 Equipment in close proximity to the human body but external to it . 42 A.1.1.3 Applicative simulator . 42 A.1.1.3.1 General matters . 42 A.1.1.3.2 Vertical Human torso simulator for LP-AMI . 42 A.1.1.3.3 Horizontal Human torso simulator for LP-AMI . 43 A.1.2 Test antenna . 44 A.1.3 Substitution antenna . 44 A.1.4 Optional additional indoor site . 45 A.2 Guidance on the use of radiation test sites . 46 A.2.1 Measuring distance . 46 A.2.2 Test antenna . 46 A.2.3 Substitution antenna . 46 A.2.4 Artificial antenna . 46 A.2.5 Auxiliary cables . 46 A.3 Further optional alternative indoor test site using an anechoic chamber . 47 A.3.1 Example of the construction of a shielded anechoic chamber . 47 A.3.2 Influence of parasitic reflections in anechoic chambers . 47 A.3.3 Calibration of the shielded RF anechoic chamber . 48 Annex B (informative): Bibliography . 50 History . 51
SIST EN 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 6 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 European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). For non EU countries the present document may be used for regulatory purposes. The present document is part 1 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.8]. 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 2013
Introduction LP-AMI/LP-AMI-P equipment in the AMICS is a unique new technology, that will provide for example high speed communications capability between individuals with AIMDs and medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to individuals with various illnesses. Equipment in the AMICS consists of LP-AMI and/or LP-AMI-P that provide human therapeutic and diagnostic data storage and analysis capability. The present document includes methods of measurement for Low Power Active Medical Implants (LP-AMI), and Peripherals (LP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing the characteristics being measured are not expected to be affected. If equipment, which is available on the market, is required to be checked it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. SIST EN 301 559-1 V1.1.2:2012
ETSI ETSI EN 301 559-1 V1.1.2 (2012-06) 7 Clause 4 provides a guide to requirements, the number of samples required in order that tests may be carried out and any markings on the equipment that the provider has to supply. Clauses 5 and 6 provide
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