DANSK DS/EN 301 489-29 V2.1.1 [ Active ]

The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated with Ultra Low Power Active Medical Implants (ULP-AMIs), Ultra Low Power Active Medical Devices (ULP-AMDs), Ultra Low Power Body Worn Devices (ULP-BWDs) and associated Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-Ps), Ultra Low Power Active Medical Device Peripherals (ULP-AMD-Ps) in respect of ElectroMagnetic Compatibility (EMC). The radio link may be part of life supporting or non life supporting equipment and can be classified independently of the classification of the medical portion of the device. The present document covers the EMC requirements for the radio functions of ultra low power implanted, body worn and associated ultra low power peripheral devices. Technical specifications related to the antenna port and emissions from the enclosure port of these radio system devices are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document applies to ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices with RF power levels ranging up to 25 µW ERP and intended for operation in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz in accordance with the provisions of annex 12, band b) and band c), to CEPT/ERC/REC 70-03 [i.3]. Definitions of such ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P radio devices are found in the following functional radio standard: • ETSI EN 302 537 [2]: "Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU". In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence. The environmental classification and the emission and immunity requirements used in the present document are as stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 [1], are aimed to cover requirements to demonstrate an adequate level of electromagnetic compatibility.