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Important

Other Parts Discussed in Thread: SYSBIOS

We plan on using SYSBIOS in a class 3 medical device

I found this below BLURB in a pdf for TI-RTOS which is based on SYSBIOS

Is this agreement required for SYSBIOS as well

Buyer acknowledges and agrees that it is solely responsible for compliance with all legal, regulatory and safety-related requirements
concerning its products, and any use of TI components in its applications, notwithstanding any applications-related information or support
that may be provided by TI. Buyer represents and agrees that it has all the necessary expertise to create and implement safeguards which
anticipate dangerous consequences of failures, monitor failures and their consequences, lessen the likelihood of failures that might cause
harm and take appropriate remedial actions. Buyer will fully indemnify TI and its representatives against any damages arising out of the use
of any TI components in safety-critical applications.
In some cases, TI components may be promoted specifically to facilitate safety-related applications. With such components, TI’s goal is to
help enable customers to design and create their own end-product solutions that meet applicable functional safety standards and
requirements. Nonetheless, such components are subject to these terms.
No TI components are authorized for use in FDA Class III (or similar life-critical medical equipment) unless authorized officers of the parties
have executed a special agreement specifically governing such use.

  • Mark:

    I will look into this. The answer probably depends on the license you downloaded SYS/BIOS under. That could be SYS/BIOS itself or CCS. I will also check with legal on what exactly that last phrase means.

    Nick

  • Mark:

    I just remembered (and confirmed by checking the downloads at: http://www.ti.com/tool/sysbios) that SYS/BIOS under a BSD-style open source license so there are no restrictions on distribtion (or which applications you use it in). Most of TI-RTOS is under a similar BSD license so you could use it to but not USB or graphics.

    I will talk to TI Legal as well to understand the intent of that clause for our proprietary-licensed code.

    Nick

     

  • Mark:

    I did some further checking and the reference to "components' in the sentence about no use of them in FDA Class III applications actually refers to TI hardware components such as microcontrollers, ADCs, etc. So I believe you company either has or needs to sign the appropriate license for the silicon components to use them in an FDA Class III application. You should probably check with the folks on your side to see if this has been done.

    Regards,

    Nick

  • We have that agreement in place for the processor since we have strict guidlines to get certified like classify SYSBIOS as SOUP under IEC 62403 I was asked to check this out by Quality. Now I am helping to determine what rigor we need to test this. My FAA experience with RTOS's leads me to belive extensive testing including code coverage is required but no one seems to know for sure what FDA requires. In looking at other RTOS's out there they offer a cert package for FDA class 3 devices the question is this a marketing gimmick or a necessity. If anyone has used SYSBIOS for a class 3 medical device and has experience or knows of a company who did that a referal would be awesome. Thanks for all the diligence Nick