AM3354: provide a software document about Linux in the medical device for FDA certification

Hello Qingyong,

Please note that our Important notice and disclaimer states "You are solely responsible for (1) selecting the appropriate TI products for your application, (2) designing, validating and testing your application, and (3) ensuring your application meets applicable standards, and any other safety, security, or other requirements."

Hercules and C2000 parts have software that was developed with IEC 60730 in mind, as per post IEC60730 Class C microcontrollers. However, I am not aware of any software that supports testing IEC 60730 on AM335x. Note also that those parts are using RTOS operating system. I am not aware of any TI Linux-based software that supports testing ICE 60730.

The requests that I can find about ICE 62304 compliance are all for C2000 parts running RTOS (RTOS/TMS320F28069F: Medical RTOS for Piccolo., TMS320F28035: IQMath verification documentation). You are the only request I can find about ICE 62304 on AM335x Linux. I need to check with other engineers, so further replies may be delayed until after the holidays.

What class of ICE 62304 is your design targeting?

Regards,

Nick

Hello Nick,

First I will answer your previous question, "What class of ICE 62304 is your design targeting?", the finished software is classified as Class B based on IEC62304.

Our medical device is developed based on the BSP using Linux  provided by TI , the Linux Software we used is Off-the-shelf (OTS) Software for our company's medical equipment.

Regarding OTS Software, the FDA officially defines: “Off-the-Shelf Software (OTS Software) - A generally available software component, used by a medical device manufacturer for which the manufacturer cannot claim complete software life cycle control.”

Off-the-shelf (OTS) Software is commonly being considered for incorporation into medical devices as the use of general-purpose computer hardware becomes more prevalent. The use of OTS Software in a medical device allows the manufacturer to concentrate on the application software needed to run device-specific functions. However, OTS Software intended for general-purpose computing may not be appropriate for a given specific use in a medical device. The medical device manufacturer using OTS Software generally gives up software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device.

Therefore, we need to provide corresponding information to describe and analyze the risk of OTS software (herein Linnux software) to support the entire product software life cycle.

In summary, I hope you can help provide Linnux's Basic Documentation for OTS Software or software life cycle documents based on the IEC62304 standard.

Regards,

Qingyong

Follow-up:

RISK ANALYSIS
After checking with other engineers, we do not perform use-case specific risk analysis on our Linux software. It is up to the user to perform that risk analysis.

SOFTWARE LIFE CYCLE
Adding onto the information in the previous post: We have continued to release Linux Processor SDKs for AM335x through SDK 6.3 / Linux 4.19 (released March 2020). We have an SDK 7.x / Linux 5.4 release that will be released some time in 1H 2021. Eventually we will stop releasing updated SDKs for AM335x (i.e., the software will be considered "mature" and will no longer have active development). But I cannot comment on whether the Linux software will become mature in 2022, 2030, etc.

Regards,

Nick

Hello Nick,

Actually, the question I want to ask comes from that FDA OTS document,as follows:

How do you know the linux software works?
Based on the Level of Concern:
· Describe testing, verification, and validation of the linux Software and ensure it is
appropriate for the device hazards associated with the linux Software. (See Note 1.)
· Provide the results of the testing. (See Note 2.)
· Is there a current list of linux Software problems (bugs) and access to updates?

Note 1: FDA recommends that software test, verification, and validation plans identify the
exact linux Software (title and version) that is to be used. When the software is tested it
should be integrated and tested using the specific linux Software that will be delivered to the
user.
Note 2: If the manufacturer allows the use of the medical device with different versions of
linux Software, then the manufacturer should validate the medical device for each linux
Software version.

Regards,

Qingyong

Hello Qingyong,

You can find release notes for the older SDKs at this wiki page. Please note that the wiki pages will be taken offline January 15 2021, so I suggest saving a local copy of any pages that you think you will want to refer to.

You can find performance testing information at this wiki page. (look at the bottom of the page for archived versions, including 02.00.00.02)

If you need to see other wiki pages but are getting redirected, try changing the url from processors.wiki.ti.com/index.php/PageName to processors.wiki.ti.com/index.php?title=PageName . Note that both of these kinds of wiki URLs will go offline January 15.

The release notes list bugs that were known at the time of SDK release. However, there have been many software changes between Linux 4.1 and Linux 4.19. Beyond the release notes, I do not have an easy way for you to see every bug that was found and fixed, and every driver that was changed between SDK 2.0.0.2 in April 2016 and some later SDK release.

Once we release an SDK, we do not provide updates to patch that SDK. Instead, bugs are noted and fixed in later SDK releases.

Note that you should independently test and validate the software that you plan to use in your system, outside of the tests that we run.

Regards,

Nick