ETSI EN 302 195-2-2004 Electromagnetic compatibility and Radio spectrum Matters (ERM) Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Imp_1.pdf

1、 ETSI EN 302 195-2 V1.1.1 (2004-03)Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 9 kHz to 315 kHzfor Ultra Low Power Active Medical Implants (ULP-AMI)and accessories;Part 2: Harm

2、onized 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). Pursuant

3、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

4、. Foreword This Candidate Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document is part 2 of a multi-part deliverable covering Radio equipment in the frequency range

5、9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, as identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R it provides scope for standards to be added: - under artic

6、le 3.2 when new frequency bands are agreed; or - under article 3.3 should the Commission take the necessary decisions without requiring alteration of standards that are already published; it clarifies, simplifies and promotes the usage of Harmonized Standards as the relevant means of conformity asse

7、ssment. ETSI ETSI EN 302 195-2 V1.1.1 (2004-03) 7 1 Scope The present document applies to Ultra Low Power Active Medical Implants (ULP-AMI) transmitters and receivers: transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m; receivers operating in the range fr

8、om 9 kHz to 315 kHz. The present document applies to ULP-AMI devices: either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna; for telecommand, telemetry etc. applications; for all types of digital modulation; with or without speech. The present docume

9、nt covers fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient). All types of digital modulation for implanted radio devices and associated accessori

10、es are covered by the present document. The power class designation is based on CEPT/ERC Recommendation 70-03 3. Table 1: Maximum radiated H-field or power (e.i.r.p.) Power Class Radiated H-field or power level 1 7 dBA/m at 10 m 2 42 dBA/m at 10 m 3 72 dBA/m at 10 m (at 9 kHz to 30 kHz, descending 3

11、 dB/octave from 30 kHz 135 kHz 4 37,7 dBA/m at 10 m (at 135 kHz, descending 3 dB/octave from 135 kHz to 1 MHz) 29 dBA/m at 10 m (at 1,0 MHz descending 9 dB/octave from 1 MHz to 4,642 MHz) 5 9 dBA/m at 10 m (4,642 MHz to 30 MHz) Refer to annex 12, band (b) 30 dBA/m at 10 m The present document is int

12、ended to cover the provisions of article 3.2 of Directive 1999/5/EC (R Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 1: Technical characteristics and test methods“. 3 CEPT/ERC Recommendation 70-03: “Relating to the

13、 use of Short Range Devices (SRD)“. 4 ETSI ETR 028 (1994): “Radio Equipment and Systems (RES); Uncertainties in the measurement of mobile radio equipment characteristics“. 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

14、information in the field of technical standards and regulations. 6 Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (EMC directive). 7 Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the

15、 laws of Member States relating to electrical equipment designed for use within certain voltage limits (LV directive). 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in the R the value of the measurement uncertainty

16、for the measurement of each parameter shall be separately included in the test report; the value of the measurement uncertainty shall be, for each measurement, equal to or lower than the figures in table 2. Table 2: Measurement uncertainty RF frequency 1 10-7RF power, conducted 1 dB Conducted emissi

17、on of receivers 1 dB Radiated emission of transmitter 6 dB Radiated emission of receiver 6 dB Temperature 1C Humidity 5 % For the test methods, according to the present document the uncertainty figures shall be calculated according to the methods described in the ETR 028 4 and shall correspond to an

18、 expansion factor (coverage factor) k = 1,96 or k = 2 (which provide confidence levels of respectively 95 % and 95,45 % in case where the distributions characterizing the actual measurement uncertainties are normal (Gaussian). Table 2 is based on such expansion factors. The particular expansion fact

19、or used for the evaluation of the measurement uncertainty shall be stated. ETSI ETSI EN 302 195-2 V1.1.1 (2004-03) 12Annex A (informative): Bibliography 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 (

20、AMD Directive). ECC Report 12 (2002): “ULTRA LOW POWER ACTIVE MEDICAL IMPLANT SYSTEMS (ULP-AMI)“. RADIOFREQUENCY RADIATION DOSIMETRY HANDBOOK (October 1986): USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. ETSI ETSI EN 302 195-2 V1.1.1 (200

21、4-03) 13Annex B (informative): The EN title in the official languages Language EN title Czech Danish DutchEnglish Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessor

22、ies; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive Estonian Finnish French German Greek Hungarian Icelandic Italian Latvian Lithuanian Maltese Polish Portuguese Slovak Slovenian Spanish Swedish ETSI ETSI EN 302 195-2 V1.1.1 (2004-03) 14History Document history V1.1.1 May 2003 Public Enquiry PE 20030919: 2003-05-21 to 2003-09-19 V1.1.1 January 2004 Vote V 20040312: 2004-01-12 to 2004-03-12 V1.1.1 March 2004 Publication