ETSI EN 302 510-2-2007 Electromagnetic compatibility and Radio spectrum Matters (ERM) Radio equipment in the frequency range 30 MHz to 37 5 MHz for Ultra Low Power Active Medical M_1.pdf

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1、 ETSI EN 302 510-2 V1.1.1 (2007-07)Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range30 MHz to 37,5 MHz for Ultra Low Power ActiveMedical Membrane Implants and Accessories;Part 2: Harmonized EN

2、 covering essential requirementsof article 3.2 of the R 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 ET

3、SI 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. Forewor

4、d 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 Dire

5、ctive 98/34/EC 4 (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 r

6、eferencing the Council Directive on the approximation of the laws of the Member States relating to electromagnetic compatibility (“the EMC Directive“) (2004/108/EC 5 as amended) and Directive 1999/5/EC 1 of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommuni

7、cations terminal equipment and the mutual recognition of their conformity (“the R Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 1: Tec

8、hnical characteristics and test methods“. 3 ETSI TR 100 028 (V1.3.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics Part 1“. 4 Directive 98/34/EC of the European Parliament and of the Council of 22 June 199

9、8 laying down a procedure for the provision of information in the field of technical standards and regulations. 5 Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility an

10、d repealing Directive 89/336/EEC (EMC Directive). 6 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AMD Directive). ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 7 3 Definitions, symbols and abbreviations 3.

11、1 Definitions For the purposes of the present document, the terms and definitions given in the R - the value of the measurement uncertainty for the measurement of each parameter shall be included in the test report; - the recorded value of the measurement uncertainty shall be, for each measurement,

12、equal to or lower than the figures in table 1. ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 10For the test methods, according to the present document, the measurement uncertainty figures shall be calculated in accordance with TR 100 028 3 and shall correspond to an expansion factor (coverage factor) k =

13、1,96 or k = 2 (which provide confidence levels of respectively 95 % and 95,45 % in the case where the distributions characterizing the actual measurement uncertainties are normal (Gaussian). Table 1 is based on such expansion factors. Table 1: Maximum measurement uncertainty RF frequency 1 x10-7RF p

14、ower, conducted 1 dB RF power, radiated 6 dB Temperature 1CHumidity 5 % 5.3 Essential radio test suites 5.3.1 Effective radiated power of the fundamental emission The test for effective radiated power of the fundamental emission specified in EN 302 510-1 2, clause 7.2.3 appropriate to the EUT shall

15、be carried out. The results obtained shall be compared to the limits in clause 4.2.2.2 in order to assess compliance with the requirement. 5.3.2 Out of band emissions The test for effective radiated power of the fundamental emission specified in EN 302 510-1 2, clause 7.3.2 appropriate to the EUT sh

16、all be carried out. The results obtained shall be compared to the limits in clause 4.2.3.2 in order to assess compliance with the requirement. 5.3.3 Unwanted emissions in the spurious domain The test for effective radiated power of unwanted emissions in the spurious domain specified in EN 302 510-1

17、2, clause 7.4.2 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.4.2 in order to assess compliance with the requirement. 5.3.4 Blocking or desensitization The test for blocking or desensitization of receivers specified in EN 302 510-1 2,

18、 clause 8.1.2 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.6.2 in order to assess compliance with the requirement. 5.3.5 Spurious radiation of receivers The test for spurious radiation of receivers specified in EN 302 510-1 2, clause

19、 8.2.2 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.7.2 in order to assess compliance with the requirement. 5.3.6 Normal and extreme test-conditions The test conditions shall be as declared by the manufacturer. The requirements and t

20、est procedures shall be as specified in EN 302 510-1 2, clauses 5.3 and 5.4. 5.3.7 Test power source The test power source shall meet the requirements of EN 302 510-1 2, clause 5.2. ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 115.3.8 Choice of samples for test suites Measurement shall be performed, acco

21、rding to the present document, on samples of equipment defined in EN 302 510-1 2, clauses 4.2.1 and 4.2.2. ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 12Annex A (normative): HS Requirements and conformance Test specifications Table (HS-RTT) The HS Requirements and conformance Test specifications Table (

22、HS-RTT) in table A.1 serves a number of purposes, as follows: it provides a statement of all the essential requirements in words and by cross reference to (a) specific clause(s) in the present document or to (a) specific clause(s) in a specific referenced document; it provides a statement of all the

23、 test procedures corresponding to those essential requirements by cross reference to (a) specific clause(s) in the present document or to (a) specific clause(s) in (a) specific referenced document(s); it qualifies each requirement to be either: - Unconditional: meaning that the requirement applies i

24、n all circumstances; or - Conditional: meaning that the requirement is dependant on the manufacturer having chosen to support optional functionality defined within the schedule. in the case of Conditional requirements, it associates the requirement with the particular optional service or functionali

25、ty; it qualifies each test procedure to be either: - Essential: meaning that it is included with the Essential Radio Test Suite and therefore the requirement shall be demonstrated to be met in accordance with the referenced procedures; - Other: meaning that the test procedure is illustrative but oth

26、er means of demonstrating compliance with the requirement are permitted. Table A.1: HS Requirements and conformance Test specifications Table (HS-RTT) Harmonized Standard EN 302 510-2 The following essential requirements and test specifications are relevant to the presumption of conformity under Art

27、icle 3.2 of the R those designated “O“ make up the Other Test Suite; for those designated “X“ there is no test specified corresponding to the requirement. The completion of all tests classified “E“ as specified with satisfactory outcomes is a necessary condition for a presumption of conformity. Comp

28、liance with requirements associated with tests classified “O“ or “X“ is a necessary condition for presumption of conformity, although conformance with the requirement may be claimed by an equivalent test or by manufacturers assertion supported by appropriate entries in the technical construction fil

29、e. Clause Number Identification of clause(s) defining the test specification in the present document unless another document is referenced explicitly. Where no test is specified (that is, where the previous field is “X“) this field remains blank. ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 14Annex B (in

30、formative): The EN title in the official languages Language EN title Bulgarian E (ERM). 30 MHz 37,5 MHz . 2: (EN), 3.2 (R Radio udstyr med ultra lav sendeeffekt, der benytter frekvensomrdet 30 til 37,5 MHz, beregnet til aktive medicinske membran implantater og tilbehr - Del 2: Harmoniseret EN som dk

31、ker de vsentlige krav i RRadioapparatuur in het frequentiegebied van 30 MHz tot 37,5 MHz met ultra-laag vermogen, voor actieve medische membraan inplantaten en toebehoren;Deel 2: Geharmoniseerde EN welke invulling geeft aan de essentile eisen van artikel 3.2 van de R Radio equipment in the frequency

32、 range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R Raadiosagedusalas 30 MHz kuni 30,5 MHz ttavad vga vikese vimsusega aktiivsed meditsiinilised membraanimplantaadid ja nende lis

33、atarvikud; Osa 2: Harmoneeritud EN R 30 - 37,5 MHz:n taajuusalueella toimivat radiolaitteet erittin pienitehoisille aktiivisille lketieteellisille kalvoistutteille ja niiden lislaitteille; Osa 2: Yhdenmukaistettu standardi (EN), joka kattaa R Apparecchiatura radiofonica nella gamma di frequenza 30 m

34、egahertz - 37.5 megahertz per Ultra Low Power Active Medical Membrane Implants and Accessories; Parte 2: EN armonizzata che soddisfa le esigenze essenziali dellarticolo 3.2 di R 2. daa:Harmonizts Eiropas standarts (EN), kas atbilst R Tagmir radjofoniku fil-medda ta frekwenzi 37,5 MHz gal Implantazzj

35、onijiet Membrani Medii Attivi bEnerija Ultra-Baxxa u Aessorji taghom Parti 2: EN armonizzat li jkopri rekwiiti essenzjali tat l-artiklu 3.2 tad-Direttiva R Equipamentos de rdio na faixa de frequncias de 30 MHz a 37,5 MHz para Implantes Mdicos Activos de Membranas de Ultra Baixa Potncia e Acessrios;

36、Parte 2: EN Harmonizada cobrindo os requisitos essenciais no mbito do artigo 3., n. 2, da Directiva R Echipamente radio n domeniul de frecven de la 30 MHz pn la 37,5 pentru implanturi active de membrane medicale cu putere ultra mic i accesorii; Partea 2: EN armonizat acoperind cerinele eseniale ale

37、Articolului 3.2 al Directivei R Equipos radioelctricos en la gama de frecuencias de 30 MHz a 37,5 MHz para Implantes Mdicos Activos de Membrana de Potencia Ultra Baja y Accesorios; Parte 2: Norma Europea (EN) armonizada que cubre los requisitos esenciales segn el artculo 3.2 de la Directiva RTTE Swe

38、dish Elektromagnetisk kompatibilitet och radiospektrumfrgor (ERM); Radioutrustning i frekvensomrdet 30 MHz till 37,5 MHz fr aktiva medicinska membran-implantat med extrem lg effekt samt kringutrustning; Del 2: Harmoniserad EN omfattande vsentliga krav enligt artikel 3.2 i R ElectroMagnetic Compatibi

39、lity (EMC) standard for radio equipment and services“. Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (LV Directive). ETSI ETSI EN 302 510-2 V1.1.1 (2007-07) 17History Document history V1.1.1 May 2006 Public Enquiry PE 20060929: 2006-05-31 to 2006-09-29 V1.1.1 April 2007 Vote V 20070615: 2007-04-16 to 2007-06-15 V1.1.1 July 2007 Publication