ETSI EN 302 537-2-2007 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Ultra Low Power Medical Data Service Systems operating in the freque.pdf

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1、 ETSI EN 302 537-2 V1.1.2 (2007-12)Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Medical Data Service Systemsoperating in the frequency range401 MHz to 402 MHz and 405 MHz to 406 MHz;Pa

2、rt 2: Harmonized EN 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).

3、 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 presen

4、t 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

5、 under Council Directive 98/34/EC 3 (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 Eur

6、opean Communities referencing the Directive 1999/5/EC 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 (R Part 2: “Harmonized EN covering essential requirements of article 3.2 of

7、the R with or without an integral antenna; and/or with an antenna connection provided only for the purpose of connecting an external dedicated antenna. In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of article

8、 3 of the R - for informative references. Referenced documents which are not found to be publicly available in the expected location might be found at http:/docbox.etsi.org/Reference. For online referenced documents, information sufficient to identify and locate the source shall be provided. Prefera

9、bly, the primary source of the referenced document should be cited, in order to ensure traceability. Furthermore, the reference should, as far as possible, remain valid for the expected life of the document. The reference shall include the method of access to the referenced document and the full net

10、work address, with the same punctuation and use of upper case and lower case letters. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long term validity. 2.1 Normative references The following referenced documents are indispensable

11、 for the application of the present document. For dated references, only the edition cited applies. For non-specific references, the latest edition of the referenced document (including any amendments) applies. 1 ETSI EN 302 537-1 (V1.2.1): “Electromagnetic compatibility and Radio spectrum Matters (

12、ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 1: Technical characteristics and test methods“. 2 ETSI TR 100 028 (V1.4.1): “ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);

13、Uncertainties in the measurement of mobile radio equipment characteristics“. 2.2 Informative references 3 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. 4 C

14、ouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices (MD Directive). 5 CEPT/ERC/REC 70-03 (2006): “Relating to the use of Short Range Devices (SRD)“. 6 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications termina

15、l equipment and the mutual recognition of their conformity (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, equal to or lower than the figures in t

16、able 1. For the test methods, according to the present document, the measurement uncertainty figures shall be calculated in accordance with TR 100 028 2 and shall correspond to an expansion factor (coverage factor) k = 1,96 or k = 2 (which provide confidence levels of respectively 95 % and 95,45 % i

17、n the case where the distributions characterizing the actual measurement uncertainties are normal (Gaussian). Table 1 is based on such expansion factors. ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 12Table 1: Maximum measurement uncertainty Parameter Maximum measurement uncertainty Radio Frequency 1 x 1

18、0-7Adjacent channel power 3 dB RF power, conducted 0,75 dB Conducted emission of transmitter 4 dB Conducted emission of receivers 3 dB Radiated emission of transmitter, valid up to 4 GHz 6 dB Radiated emission of receiver, valid up to 4 GHz 6 dB Conducted monitoring test system 4 dB Radiated monitor

19、ing test system 6 dB Temperature 1C Humidity 5 % Voltag 15.3 Essential radio test suites 5.3.1 Frequency error The test for frequency error specified in EN 302 537-1 1, clause 8.1 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.2.2 in o

20、rder to assess compliance with the requirement. 5.3.2 Emission bandwidth The test for emission bandwidth specified in EN 302 537-1 1, clause 8.2.1.1 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.3.2 in order to assess compliance with

21、the requirement. 5.3.3 Effective radiated power of the fundamental emission The test for effective radiated power of the fundamental emission specified in EN 302 537-1 1, clause 8.3.1.1 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.4.

22、2 in order to assess compliance with the requirement. 5.3.4 Spurious emissions The test for spurious emissions specified in EN 302 537-1 1, clause 8.4.1.1 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause 4.2.5.2 in order to assess compliance

23、 with the requirement. 5.3.5 Frequency stability under low voltage conditions The test for frequency stability under low voltage conditions specified in EN 302 537-1 1, clause 8.5.1.1 shall be carried out. The results obtained shall be compared to the limits in clause 4.2.6.2 in order to assess comp

24、liance with the requirement. 5.3.6 Spurious radiation of receivers The test for spurious radiation of receivers specified in EN 302 537-1 1, clause 9.1.1.1 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 complianc

25、e with the requirement. ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 135.3.7 Spectrum access for systems using LBT/AFA The tests for spectrum access requirements specified in EN 302 537-1 1, clause 10 and applicable subsequent clauses shall be carried out. The results obtained shall be compared to the re

26、quirements listed in clause 4.2.8.1.2. 5.3.8 Spectrum access for devices using low power and low duty cycle The tests for spectrum access requirements specified in EN 302 537-1 1, clause 10 and applicable subsequent clauses (8.3.2.2, 8.6.2.1 and 8.6.2.2) shall be carried out. The results obtained sh

27、all be compared to the requirements listed in clause 4.2.8.2.2. 5.3.9 Normal and extreme test-conditions The test conditions shall be as declared by the provider. The requirements and test procedures shall be as specified in EN 302 537-1 1, clauses 5.3 and 5.4. 5.3.10 Test power source The test powe

28、r source shall meet the requirements of EN 302 537-1 1, clause 5.2. 5.3.11 Choice of samples for test suites Measurement shall be performed, according to the present document, on samples of equipment defined in EN 302 537-1 1, clause 4.2 (clauses 4.2.1, 4.2.2 and 4.2.3). ETSI ETSI EN 302 537-2 V1.1.

29、2 (2007-12) 14Annex A (normative): HS Requirements and conformance Test specifications Table (HS-RTT) The HS Requirements and conformance Test specifications Table (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

30、 cross reference to (a) specific clause(s) in the present document or to (a) specific clause(s) in (a) specific referenced document(s); it provides a statement of all the test procedures corresponding to those essential requirements by cross reference to (a) specific clause(s) in the present documen

31、t 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 in all circumstances; or - Conditional: meaning that the requirement is dependent on the manufacturer having chosen to support opti

32、onal functionality defined within the schedule; in the case of Conditional requirements, it associates the requirement with the particular optional service or functionality; it qualifies each test procedure to be either: - Essential: meaning that it is included with the Essential Radio Test Suite an

33、d therefore the requirement shall be demonstrated to be met in accordance with the referenced procedures; - Other: meaning that the test procedure is illustrative but other means of demonstrating compliance with the requirement are permitted. ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 15Table A.1: HS R

34、equirements and conformance Test specifications Table (HS-RTT) Harmonized Standard EN 302 537-2 The following technical requirements and test specifications are relevant to the presumption of conformity under Article 3.2 of the R those designated “O“ make up the Other Test Suite; for those designate

35、d “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. Compliance with requirements associated with tests classified “O“ or “X“ is a necessary cond

36、ition 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 file. ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 16Clause Number Identification of clause(s) d

37、efining 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 302 537-2 V1.1.2 (2007-12) 17Annex B (informative): The EN title in the official langu

38、ages Language EN title Bulgarian E (ERM); (SRD); , 401 MHz 402 MHz 405 MHz 406 MHz; 2: (EN), 3.2 (R Apparater med kort rkkevidde (SRD); Medicinske datakommunikations systemer med ultra lav sendeeffekt som benytter frekvenser mellem 401 MHZ og 402 MHZ eller frekvenser mellem 405 MHZ og 406 MHz Del 2:

39、 Harmoniseret EN, som dkker de vsentlige krav i RKort bereik apparatuur (SRD);Medische data service met ultra-laag vermogen in het frequentiegebied 401 MHz tot 402 MHz en 405 MHz tot 406 MHz;Deel 2: Geharmoniseerde EN welke invulling geeft aan de essentile eisen van artikel 3.2 van de R Short Range

40、Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R Lhitoimeseadmed (SRD); Raadiosagedusalades 402 MHz kuni 405 MHz ja 405 MHz kuni 406 MH

41、z ttavad vga vikese vimsusega meditsiini andmesidessteemid; Osa 2: Harmoneeritud EN R Lyhyen kantaman laitteet (SRD); Taajuusalueella 401 - 402 MHz ja 405 - 406 MHz toimivat erittin pienitehoiset lketieteen datansiirtojrjestelmt; Osa 2: Yhdenmukaistettu standardi (EN), joka kattaa R oti zemas jaudas

42、 medicnisko datu pakalpojumu sistmas, kas strd frekvenu josl no 401 MHz ldz 402 MHz un no 405 MHz ldz 406 MHz; 2.daa: Harmonizts Eiropas standarts (EN), kas atbilst R Apparati ta Medda Qasira (SRD); Sistemi ta servizz ta data medii li joperaw fil-medda ta frekwenzi 401 MHz sa 402 u 405 MHz sa 406 u

43、MHz; Parti 2: EN armonizzat li jkopri rekwiiti essenzjali ta l-artiklu 3.2 tad-Direttiva R Kortholdsutstyr (SRD); Ultralavt styrket medisinsk datatjenesteutstyr system som opererer i frekvensbndet 401 MHz til 402 MHz og 405 MHz til 406 MHz; Del 2: Harmonisert EN som dekker de grunnleggende krav i R

44、Urzdzenia bliskiego zasigu (SRD); Systemy transmisji danych do celw medycznych o ultra niskim poziomie mocy, pracujce w zakresie czstotliwoci od 401 MHz do 402 MHz i od 405 MHz do 406 MHz; Cz 2: Zharmonizowana EN zapewniajca spenienie zasadniczych wymaga artykuu 3.2 dyrektywy R Equipamentos de Curto

45、 Alcance (SRD); Sistemas de Ultra Baixa Potncia para Servios de Dados Mdicos operando nas faixas de frequncias de 401 MHz a 402 MHz e de 405 MHz a 406 MHz; Parte 2: Norma Harmonizada cobrindo os requisitos essenciais no mbito do artigo 3., n. 2, da Directiva R Dispositivos de Corto Alcance (SRD); Si

46、stemas para el Servicio de Datos Mdicos de Potencia Ultra Baja operando en la gama de frecuencias de 401 MHz a 402 MHz y de 405 MHz a 406 MHz; Parte 2: Norma Europea (EN) armonizada cubriendo los requisitos esenciales segn el artculo 3.2 de la Directiva R Kortdistansutrustning (SRD); Medicinska data

47、servicesystem med extrem lg effekt arbetande i frekvensomrdena 401 MHz till 402 MHz och 405 MHz till 406 MHz; Del 2: Harmoniserad EN omfattande vsentliga krav enligt artikel 3.2 i R&TTE-direktivet ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 19Annex C (informative): Bibliography Radiofrequency Radiation

48、Dosimetry Handbook (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. ETSI ETSI EN 302 537-2 V1.1.2 (2007-12) 20History Document history V1.1.1 December 2006 Public Enquiry PE 20070406: 2006-12-06 to 2007-04-06 V1.1.2 October 2007 Vote V 20071214: 2007-10-15 to 2007-12-14 V1.1.2 December 2007 Publication