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USB-IF standard includes also ISO13485

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Francesco.l, Apr 30, 2021.

  1. Francesco.l

    Francesco.l New Member

    Apr 30, 2021
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    Hi all,

    we are design a portable biomedical device. We need to provide also a charging cable with ubs type c to type A. The first requirements is that the cable is compliant with USB-IF standard. This is compliant with ISO60601 and EIA-364.

    Is USB-IF enough for medical device? Or we should look for a different cable/connectors?
    Is the USB-IF standard compliant also with ISO13485?

    Thanks a lot!!
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Jul 30, 2015
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    In the "Rust Belt"
    ISO 13485 is a set of requirements for an organization designing and/or making a medical device and there's no "compliance" relationship to product - except that the organization's product may need to be compliant with a regulation/spec. ISO 13485 is "agnostic" to such issues.
    Francesco.l likes this.

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