ETSI EN 301 559-2-2012 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Low Power Active Medical Implants (LP-AMI) operating in the frequenc_1.pdf

1、 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、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:/ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has

3、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

4、 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 pres

5、ent 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 Standard

6、s 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

7、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“; Pa

8、rt 2: “Harmonized EN covering the essential requirements of article 3.2 of the R 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 documen

9、t 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 import

10、ance 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 standar

11、d 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. In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of ar

12、ticle 3 of the R 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“. 2 ETSI TR 100 028 (V1.4.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertai

13、nties in the measurement of mobile radio equipment characteristics“. 2.2 Informative references The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. i.1 Directive 1999/5/EC of the European

14、Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R System reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in a 20 MHz band within 2 360 MHz to

15、 3 400 MHz“. i.5 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. i.6 Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amendin

16、g Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations. 3 Definitions and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in EN 301 559-1 1, clause 3.1 apply. 3.2 Abbrev

17、iations For the purposes of the present document, the abbreviations given in EN 301 559-1 1, clause 3.3 apply. 4 Technical requirements and specifications 4.1 Environmental profile The technical requirements of the present document apply under the environmental profile for operation of the equipment

18、 as described in the users manual and declared by the provider. The equipment shall comply with all the technical requirements of the present document at all times when operating within the boundary limits of the operational environmental profile as described above. The provider shall declare that i

19、nterruption of the communications link for his AMICS shall not result in compromising the health and safety of the patient. ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 84.2 Conformance requirements 4.2.1 Mechanical and electrical design 4.2.1.1 General The equipment shall be designed, constructed and ma

20、nufactured in accordance with sound engineering practice and with the aim of minimizing harmful disturbance to other equipment and services. It should not be disturbed by harmful interference from other electronic devices and users of the band. Transmitters and receivers may be individual or combina

21、tion units. 4.2.1.2 Antennas Equipment operating in the AMICS shall have an integral antenna or a dedicated external antenna or both Where provision for an external antenna connection is made, the connector shall be a unique type to prevent use of an antenna other than a dedicated antenna supplied b

22、y the provider. 4.2.1.3 Controls Those controls which, if maladjusted, might increase the interfering potentialities of the equipment, shall not be accessible to the user. 4.2.1.4 Automatic transmitter shut-off facility If the transmitter is equipped with an automatic transmitter shut-off facility o

23、r battery-saving feature and it interferes with testing of the device, if possible, it shall be capable of being made inoperative for the purpose of testing. 4.2.2 Frequency error 4.2.2.1 Definition The frequency error shall be as defined in EN 301 559-1 1, clause 8.1. 4.2.2.2 Limits The frequency e

24、rror limits shall be as defined in EN 301 559-1 1, clause 8.1. 4.2.2.3 Conformance Conformance tests as defined in clause 5.3 shall be carried out. 4.2.3 Emission bandwidth 4.2.3.1 Definition The emission bandwidth shall be as defined in EN 301 559-1 1, clause 8.2. 4.2.3.2 Limits The emission bandwi

25、dth limits shall be as defined in EN 301 559-1 1, clause 8.2. 4.2.3.3 Conformance Conformance tests as defined in EN 301 559-1 1, clause 5.3 shall be carried out. ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 94.2.4 Effective isotropic radiated power of the fundamental emission 4.2.4.1 Definition The effe

26、ctive isotropic radiated power shall be as defined in EN 301 559-1 1, clause 8.3. 4.2.4.2 Limits The e.i.r.p. limit shall be as defined in EN 301 559-1 1, clause 8.3.2. 4.2.4.3 Conformance Conformance tests as defined in EN 301 559-1 1, clause 5.3 shall be carried out. 4.2.5 Transmitter unwanted s e

27、missions 4.2.5.1 Out-of-band emissions 4.2.5.1.1 Definition The out-of-band emissions of transmitters shall be as defined in EN 301 559-1 1, clause 8.5. 4.2.5.1.2 Limits The out-of-band emissions limits shall be as defined in EN 301 559-1 1, clause 8.5. 4.2.5.2 Spurious emissions 4.2.5.2.1 Definitio

28、n The transmitters spurious emissions shall be as defined in EN 301 559-1 1, clause 8.4. 4.2.5.2.2 Limits The transmitters spurious emissions limits shall be as defined in EN 301 559-1 1, clause 8.4. 4.2.5.3 Conformance Conformance tests as defined in EN 301 559-1 1 shall be carried out as defined i

29、n clause 5.3. 4.2.6 Frequency stability under low voltage conditions 4.2.6.1 Definition The frequency stability under low voltage conditions shall be as defined in EN 301 559-1 1, clause 8.6. 4.2.6.2 Limits The frequency stability under low voltage conditions limits shall be as defined in EN 301 559

30、-1 1, clause 8.6. 4.2.6.3 Conformance Conformance tests as defined in EN 301 559-1 1, clause 5.3 shall be carried out. ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 104.2.7 Spurious radiation of receivers 4.2.7.1 Definition The spurious radiation of receivers shall be as defined in EN 301 559-1 1, clause

31、9.1. 4.2.7.2 Limits The spurious radiation of receivers limits shall be as defined in EN 301 559-1 1, clause 9.1. 4.2.7.3 Conformance Conformance tests as defined in EN 301 559-1 1, clause 5.3 shall be carried out. 4.2.8 Spectrum access The spectrum access shall be as defined in EN 301 559-1 1, clau

32、se 10. 4.2.8.1 Spectrum access 4.2.8.1.1 Definition Under this method, spectrum access for AMICS is based on the system frequency of operation being under the control of a system device meeting the technical requirements of EN 301 559-1 1, clause 10. A monitoring system is the circuitry in an AMICS

33、device that assures conformity with the technical requirement for use of the spectrum access protocol specified EN 301 559-1 1, clause 10. 4.2.8.1.2 Limits The AMICS requirements are as specified in EN 301 559-1 1, clause 10 and applicable subsequent clauses. 4.2.8.1.3 Conformance Conformance tests

34、as defined in EN 301 559-1 1, clause 5.3 shall be carried out. 5 Testing for compliance with technical requirements 5.1 Environmental conditions for testing Tests defined in the present document shall be carried out at representative points within the boundary limits of the operational environmental

35、 profile as declared in clause 4.1. Where technical performance varies subject to environmental conditions, tests shall be carried out under a sufficient variety of environmental conditions (within the boundary limits of the operational environmental profile) to give confidence of compliance for the

36、 affected technical requirements. 5.2 Interpretation of the measurement results The interpretation of the results recorded in a test report for the measurements described in the present document shall be as follows: the measured value related to the corresponding limit shall be used to decide whethe

37、r an equipment meets the requirements of the present document; ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 11 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 measurem

38、ent, equal to or lower than the figures in table 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 confiden

39、ce 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: Measurement uncertainties up to 12,5 GHz for RF measurements Parameter Maximum Measurement Un

40、certainty Radio Frequency 1 10-7Adjacent 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 6 dB Radiated emission of receiver 6 dB Conducted monitoring test system 4 dB Radiated monitoring test

41、system 6 dB Temperature 1 CHumidity 5 %DC voltage 1 % AC voltage 1 % 5.3 Essential radio test suites 5.3.1 Frequency error The test for frequency error specified in EN 301 559-1 1, clause 8.1 appropriate to the EUT shall be carried out. The results obtained shall be compared to the limits in clause

42、4.2.2.2 in order to assess compliance with the requirement. 5.3.2 Emission bandwidth The test for emission bandwidth specified in EN 301 559-1 1, clause 8.2 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 complian

43、ce with the requirement. 5.3.3 Effective isotropic radiated power of the fundamental emission The test for effective isotropic radiated power of the fundamental emission specified in EN 301 559-1 1, clause 8.3 appropriate to the EUT shall be carried out. The results obtained shall be compared to the

44、 limits in clause 8.3 in order to assess compliance with the requirement. 5.3.4 Unwanted emissions 5.3.4.1 Out-of-band emissions The test for LP-AMI-P Transmitters out-of-band emissions specified in EN 301 559-1 1, clause 8.5 appropriate to the EUT shall be carried out. The results obtained shall be

45、 compared to the limits referred to in clause 8.5.3 in order to assess compliance with the requirement. ETSI ETSI EN 301 559-2 V1.1.2 (2012-06) 125.3.4.2 Transmitter spurious emissions The test for transmitter spurious emissions specified in EN 301 559-1 1, clause 8.4 appropriate to the EUT shall be

46、 carried out. The results obtained shall be compared to the limits in clause 8.4.2 in order to assess compliance with the requirement. 5.3.5 Frequency stability under low voltage conditions The test for frequency stability under low voltage conditions specified in EN 301 559-1 1, clause 8.6 shall be

47、 carried out. The results obtained shall be compared to the limits in clause 8.6.2 in order to assess compliance with the requirement. 5.3.6 Receiver spurious emissions The test for receiver spurious emissions specified in EN 301 559-1 1, clause 9.1 appropriate to the EUT shall be carried out. The l

48、imits are in EN 301 559-1 1, clause 9.1.2. 5.3.7 Spectrum access The tests for spectrum access requirements specified in EN 301 559-1 1, clause 10 and applicable subsequent clauses shall be carried out. The results obtained shall be compared to the requirements listed in clause 10. 5.3.8 Normal and

49、extreme test-conditions The test conditions shall be as declared by the provider. The requirements and test procedures shall be as specified in EN 301 559-1 1, clauses 5.3 and 5.4. 5.3.9 Test power source The test power source shall meet the requirements of EN 301 559-1 1, clause 5.2. 5.3.10 Choice of samples for test suites Measurement shall be performed, according to the present document, on samples of equipment defined in EN 301 559-1 1, clause 4.2. ETSI ETSI EN 30