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ADS1298 compliant report for AAMI EC11, EC13, IEC60601-1, IEC60601-2-27, and IEC60601-2-51 Standards

Arwin Hu31
Prodigy 20 points
Other Parts Discussed in Thread: ADS1298

Customer would like to know if we have IEC, AAMI compliant report for ADS1298?

Searched E2E, got feedback which compliant report only for system not component right?

Could you provide related documents which can support customer to pass IEC, AAMI compliant?

Thank you~

  • 0
    TI__Guru 66346 points

    Hello Arwin,

    You are correct. The IEC/AAMI standards are for end-equipment systems, not the device alone. Therefore, there is no such document other than the device datasheet. The performance specifications listed in the device datasheet demonstrate that the device does not limit the overall system performance and prevent it from meeting these standards.

    Sotera Wireless has publicly stated that they use our ADS1298 as their analog front-end in their ViSi mobile system. This product is used in hospital settings and meets all required regulatory standards.

    http://www.eetimes.com/document.asp?doc_id=1262310&page_number=2   

    Sotera Wireless – www.soterawireless.com

    Best Regards,