1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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

    Joined:
    Apr 30, 2021
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    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

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    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.