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TMS570 and safeRTOS validation

Other Parts Discussed in Thread: HALCOGEN

Hello,

we are planning to use a TMS570 Controller together with the pre-certified operating system safeRTOS in a medical device. Currently we are using the drivers generated by HALCOGEN. Does anybody know if an how these drivers can be validated? Do we just need to perform tests to prove the function of the I/O interfaces? What about the internal safety features? Do we need to care about validation of the I/O and other drivers or is documentation according to IEC 61508 / 60601 provided by TI?

Thanks in advance

Manuel Fuchs

  • Hello Manuel:

    Having previously been involved in code development in a medical application, I certainly can appreciate your concerns and questions. At this time, the Halcogen drivers are provided as is with no formal documentation of the validation available to the general public. However, there are efforts that are currently under way to provide a safety package of documentation for use with the drivers created in Halcogen. The current time line for this package/documentation is end of the year. If this time line does not meet your project needs, we can arrange for an offline exchange of information/discussion that can help in the task of validation of the drivers by giving current test metrics and planned coverage details.

    In the end, the applicability of the documentation is dependent on your specific process and application needs and should be evaluated based on these requirements. 

  • Hello Chuck,

    thanks for your input and your great offer. We will evaluate our options and possibly contact you in due time.

    Best regards

    Manuel

  • Hello Manuel:

    I wanted to add a few more details about the safety package to give a better understanding of the current plans for this package.

    As I had stated, this documentation package is currently scheduled to be released by the end of the year.

    It is tentatively planned to include the following:

    1. Traceability Matrix
    2. FMEA
    3. Test Coverage report
    4. Code Coverage report
    5. MISRA-C 2004 compliance report
    6. Test report

     

    The intent of the package is to provide the end user the material to pursue the certification of their choice or to simply have as documentation of the testing that was performed on the drivers. The pricing of this package is still in discussion and is TBD at this time.

  • Hi Chuck,

    I've read the thread from last year and I am wondering if the documentation package might be available right now.

    But i could not find any comments at the TI page.

    Are there still these plans you told last year?

    Kind regards,

    a.

  • Hello abeat,

    The release of the Safety Packages were re-prioritized and I am currently not certain when the release is scheduled. I am copying the individual responsible for the scheduling/planning for the release of the packages so that they may provide the current plans for these packages.

  • Abeat,

    The HALCoGen Compliance Support Package will be available by end of 1Q14.  It's not really that it was re-prioritized, it is just taking much longer to ensure we comply to the standards than we originally thought.  Also, HALCogen generates code which can change based on user configurations.  We need a way for you to validate your actual code, so we are working on a solution for that.  There will be more information on this as we get closer to release. 

    Best Regards,

    Roy Haley