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TMP117: Need medical certifications or reports

Chase Jeong
Mastermind 7555 points
Part Number: TMP117

Hello TI experts,

My customer considers TMP117 for their new products, and they have a request now.

I can see the sentence in the datasheet of TMP117 ;

" Medical grade: meets ASTM E1112 and ISO 80601-2-56 "

Can you provide me the certificates or test reports for ASTM E112 and ISO 80601-2-56?

My customer strongly want it, because they need to send this document to their end customer (the government).

Please check this issue. Thanks.

Best regards,

Chase

  • 0
    TI__Guru* 91206 points

    Dear Chase, 

    Thanks for the post - both standards are system level, not component level - the ASTM E1112 requirement is for +/-0.1ºC accuracy within a range of 35.8ºC to 41.0ºC, and the ISO standard requires +/-0.3ºC accuracy. The TMP117 supports these accuracy requirements easily and requires no calibration to do so, and this is the reason for the bullet point in the features section that you reference. 

    As stated, the standards are system level - no report associated or based on those can exist for this component by itself, the customer must get their complete thermometer system tested, and they should be able to do that with confidence, using the TMP117.