ETSI EN 301 839-2-2009 Electromagnetic compatibility and Radio spectrum Matters (ERM) Short Range Devices (SRD) Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (U_1.pdf

1、 ETSI EN 301 839-2 V1.3.1 (2009-10)Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Active Medical Implants (ULP-AMI)and Peripherals (ULP-AMI-P)operating in the frequency range 402 MHz to

2、405 MHz;Part 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/

3、home.asp). 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

4、the present 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 Commiss

5、ion issued under Council Directive 98/34/EC (as amended) i.3 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 Journa

6、l of the European Communities referencing the Directive 1999/5/EC i.1 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 (“the R Ultra Low Power Active Medical Implants (ULP-AMI) an

7、d Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz, as identified below: Part 1: “Technical characteristics and test methods“; Part 2: “Harmonized EN covering essential requirements of article 3.2 of the R and Peripherals (ULP-AMI-P). These radio equipment types are capabl

8、e of operating in all or any part of the frequency bands in table 1. Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) service frequency bands Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) service frequency bands Transmit Ultra Low

9、 Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz Receive Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) 402 MHz to 405 MHz The present document is intended to cover the provisions of Directive 1999/5/EC i.1 (R - for informative re

10、ferences. Referenced documents which are not found to be publicly available in the expected location might be found at http:/docbox.etsi.org/Reference. NOTE: While any hyperlinks included in this clause were valid at the time of publication ETSI cannot guarantee their long term validity. ETSI ETSI E

11、N 301 839-2 V1.3.1 (2009-10) 72.1 Normative references The following referenced documents are indispensable 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 ame

12、ndments) applies. 1 ETSI EN 301 839-1 (V1.3.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteris

13、tics and test methods“. 2 ETSI TR 100 028 (all parts) (V1.4.1): “Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics“. 2.2 Informative references The following referenced documents are not essential to the use of

14、the present document but they assist the user with regard to a particular subject area. For non-specific references, the latest version of the referenced document (including any amendments) applies. i.1 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipm

15、ent and telecommunications terminal equipment and the mutual recognition of their conformity (R it provides a statement of all the test procedures corresponding to those requirements by cross reference to (a) specific clause(s) in the present document or to (a) specific clause(s) in (a) specific ref

16、erenced 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 dependant on the manufacturer having chosen to support optional functionality defined within the schedule. in

17、 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 and therefore the requirement shall be demonstrated

18、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. Table A.1: HS Requirements and conformance Test specifications Table (HS-RTT) Harmonized Standard EN 301 83

19、9-2 The following requirements and test specifications are relevant to the presumption of conformity under the article 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 cla

20、ssified “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 condition for presumption of conformity, although conformance with the requirement may be claimed by a

21、n equivalent test or by manufacturers assertion supported by appropriate entries in the technical construction file. 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

22、, where the previous field is “X“) this field remains blank. ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 15Annex B (informative): The EN title in the official languages The enlargement of the European Union (EU) resulted in a requirement from the EU for a larger number of languages for the translation o

23、f the titles of Harmonized Standards and mandated ENs that are to be listed in the Official Journal to support the implementation of this legislation. For this reason the title translation concerning the present document can be consulted via the e-approval application. ETSI ETSI EN 301 839-2 V1.3.1

24、(2009-10) 16Annex C (informative): Bibliography CEPT/ERC/REC 70-03: “Relating to the use of Short Range Devices (SRD)“. Radiofrequency Radiation Dosimetry Handbook (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. Council Dire

25、ctive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (EMC Directive). 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 c

26、ertain voltage limits (LV Directive). ETSI EG 201 399: “Electromagnetic compatibility and Radio spectrum Matters (ERM); A guide to the production of candidate Harmonized Standards for application under the R&TTE Directive“. ETSI ETSI EN 301 839-2 V1.3.1 (2009-10) 17History Document history V1.1.1 June 2002 Publication V1.2.1 July 2007 Publication V1.3.1 January 2009 Public Enquiry PE 20090506: 2009-01-06 to 2009-05-06 V1.3.1 July 2009 Vote V 20090927: 2009-07-29 to 2009-09-28 V1.3.1 October 2009 Publication