Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; Part 29: Requirements for Medical Data Service Devices (MEDS
The present document together with 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 specifies the applicable test conditions@ performance assessment@ and performance criteria for the following equipment@ ULP-AMIs@ ULP-AMDs@ ULP-BWDs@ and associated peripheral devices ULP-AMI-Ps and ULPAMD- Ps. Definitions of types of the above equipment that are covered by the present document are given in annex A. In case of differences (for instance concerning special conditions@ definitions@ abbreviations) between the present document and 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 EN 301 489-1 [1]@ except for any special conditions included in the present document.