M/322 -
General Information
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/322 is a European Standardization Mandate titled "undefined". This mandate requests the European Standardization Organizations to develop harmonized standards supporting EU legislation. There are 3 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.
DEN/ERM-TG30-003-2
- Standard17 pagesEnglish languagee-Library read for1 day
DEN/ERM-EMC-230-31
- Standard24 pagesEnglish languagee-Library read for1 day
The present document together with EN 301 489-1 [1] covers the assessment of all radio transceivers associated with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices in respect of ElectroMagnetic Compatibility (EMC). Non-radio parts of the above equipment may be covered by other directives and/or standards when applicable.
Technical specifications related to the antenna port and emissions from the enclosure port of the radio systems of these 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 assessment of the radio communications link for ULP-AMI and ULP-AMI-Ps. 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.
- Standard24 pagesEnglish languagee-Library read for1 day