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Medical devices certification - life critical applications

YILMAZ KIRÇİÇEK
Intellectual 905 points
Other Parts Discussed in Thread: AM3874, SYSBIOS

Hi all,

Does any one know that can we use AM3874 for medical application like patient monitoring.  (with appropriate OS)

Is AM3874 appropriate for life critical application and certification. (FDA Class III or similar) ?

This device familiy is listed on patient monitor block diagram on processor list as shown at link below.

http://www.ti.com/solution/patient_monitoring#Design Considerations

And Hercules RM4x Safety MCU family is recommended for medical application but not listed on patient monitor block diagram.

Is Hercules family mondatory and sole alternative for safety applications or this familiy offered for ease of certification and other families like sitara can be certified ?

Best regards.

  • 0
    TI__Mastermind 23000 points

    Hello,

    When developing for any safety critical application, it is always up to the system developer to determine what standards are applicable and how they are to be interpreted.  In many standards today, component level compliance is not required so long as the developer can demonstrate system level compliance to the appropriate assessor or certifying body.  However, there is a general trend towards requirements for compliance at component and even sub-component levels.

    The example block diagram you note is a bit old; I believe it pre-dates the public release of the Hercules family of products.  I will bring this to our marketing department's attention.  When building such diagrams, we typically focus on functional requirements rather than safety requirements.  Please note that no statements are made in the example of the suitability of a component with respect to safety standard compliance.

    To my knowledge, there are no current Sitara family products developed compliant to functional safety standards.

    As a general guideline:

    • If you as the developer interpret the safety requirements to require system level compliance, then effectively any TI component which meets the functional requirements of the application can be used, but using a compliant component family such as Hercules may provide advantages in meeting your safety requirements.
    • If you as the developer interpret the safety requirements to require component level compliance, then use of a compliant component family such as Hercules is strongly recommended
    • If you as the developer interpret the safety requirements to require component level compliance, but no compliant components are available, then use of a component compliant to other similar safety standards is strongly recommended.
    Ultimately the developer must make the component decision and justify the choice to the assessor or certifying body.
    Regards,
    Karl
  • 0 in reply to KGreb
    Intellectual 905 points

    Hi Karl,

    I thank you very much for your answer and time.

    Best regards.

  • 0 in reply to KGreb
    Expert 1505 points

    How about the 2nd part of his question pertaining to using sysbios in same type application where  OTS DEVELOPER is TI

    Will TI allow a customer  audit of the TI's
    Software developer’s design and development methodologies used in the construction of the
    OTS Software. ie SYSBIOS????

    2.5 SPECIAL DOCUMENTATION for OTS Software
    To fulfill SPECIAL DOCUMENTATION for OTS Software of a Major Level of Concern, the
    medical device manufacturer is expected to:
    1. Provide assurance to FDA that the product development methodologies used by the OTS
    Software developer are appropriate and sufficient for the intended use of the OTS Software
    within the specific medical device. FDA recommends this include an audit of the OTS
    Software developer’s design and development methodologies used in the construction of the
    OTS Software. T

  • 0 in reply to Mark Lazarewicz
    TI__Mastermind 23000 points

    Hello Mark,

    With respect to the TI BIOS product, the experts are from our SDO group and I will ask one of them to comment here.  I know that in the past we have worked special souce code licensing deals with customers who have certified products including the TI BIOS, but I fear I do not know the details.

     

    Best Regards,
    Karl

  • 0 in reply to KGreb
    TI__Mastermind 20805 points

    We have had a couple customer audits of the BIOS development process in the past.  

    Work with your sales representative to set up a meeting if you want to go this route.

    Regards,
    -Karl-

  • 0 in reply to Karl Wechsler
    Expert 1505 points

    Hi Karl

    Appreciate the effort and help greatly

    as I interpret the FDA guidance Thats a start and will go a long way the other part is we we need to have full source code you earlier made a statement

    "in the past we have worked special souce code licensing deals with customers who have certified products including the TI BIOS"

    are you sure that statement is correct? please elaborate. the build system is hidden behind XDC tools but that s not what I am asking about,

    I am asking what exactly you meant when you made the cpmment bolded. it suggests special souce code licensing deals are needed

  • 0 in reply to Mark Lazarewicz
    TI__Mastermind 20805 points

    There are 2 Karl's on this thread.   Did I say "in the past ..."?   If so, where did I say this?   SYS/BIOS and XDC tools come with complete source code.  No special deals are required to get the source code.   DSP/BIOS 5.x did not come with source code.  The "in the past ..." might be referring to DSP/BIOS.  

    You should have all the sources in standard XDC and SYS/BIOS products.

    Thanks,
    -Karl-

  • 0 in reply to Karl Wechsler
    Expert 1505 points

    Thats the answer I was expecting. The reason I asked for clarification is some safety critcal/life critical V&V environs the fact that all the source code is not not available and gets tested is potential problem. With SysBIOS we have the source code(kind of) but all the magic that is done by XDCTOOLS may present a challange to a v&V team.