ČSN ETSI EN 301839-V2.1.1 (875113)

Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

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STANDARD published on 1.11.2016


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The information about the standard:

Designation standards: ČSN ETSI EN 301839-V2.1.1
Classification mark: 875113
Catalog number: 500506
Publication date standards: 1.11.2016
SKU: NS-666298
The number of pages: 56
Approximate weight : 168 g (0.37 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

Annotation of standard text ČSN ETSI EN 301839-V2.1.1 (875113):

V2.1.1 The present document applies to the following radio equipment types: - Ultra Low Power Active Medical Implants (ULP-AMI). - Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P). The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1]. It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz: - for telecommand and telemetry to/from an AIMD in a patient´s body to an ULP-AMI-P; or - for telecommand and telemetry to/from an AIMD to another AIMD within the human body. The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP AMI) and Peripherals (ULP AMI P) used in a Medical Implant Communications Service (MICS) ". shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the charac-teristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable



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