I have the following Questions About embedded unit testing:
- Can Google unit testing be used for embedded C Code?
- Is Google unit test compatible with IEC 62304?
I tried to find a document, which could answer my Question but unable to find that. Even in the Google Unit Test Official Documentation1, I was not able to find the answer. Also, I have the following Question:
- How would I know an open source Unit Testing Tool is compatible with IEC 62304 Standard?
Please help me with your Knowledge in Unit Testing. Thanks in Advance.
CodePudding user response：
GoogleTest seems to work with C -> https://meekrosoft.wordpress.com/2009/11/09/unit-testing-c-code-with-the-googletest-framework/
Google will not take over the responsibility for you to be compliant with IEC 62304 regarding your use cases. You have to make sure that the tools you use do what they should do for the use case you use them. For instance, you can come up with an acceptance test for GoogleTest that proves that it works for you as expected. When doing this consider also known bugs. Even if a company offers you a unit test framework that is IEC 62304 compliant I would ask myself if this test framework has more users and is better tested than gtest.
I think something like this does not exist - it would mean that the Open Source project would take over the liability for damages resulting from its users
CodePudding user response：
To answer your two questions directly:
googletest is intended for use with C . The link in Vertexwahn’s answer show that at least one person has been able to use it for testing C.
IEC 62304 is a software life cycle process, it has nothing to say about whether you can or cannot use a particular tool, only the steps which you must go through in your project.
Unit testing is certainly one step that you would go through in your software life cycle. As the engineer responsible, it is your job to decide whether or not a tool is suitable for a particular task. No person outside your project can ever tell you that a tool is suitable for use in developing a particular medical device, because this depends very highly not only on the design of the particular device, but also on the testing strategy that your are going to adopt.
The testing strategy in turn will depend on the particular risks that you need to mitigate. You will need to follow ISO 14971 for your risk management process.
At every stage of the process you will have to document the reasons for the decisions that you have made according to an ISO 13485 quality management process.
When you come to make a regulatory submission to an approved body they will appoint an auditor who will look through your documentation. In the vast majority of cases the auditor will have absolutely no technical expertise in software. They will check that you have followed the appropriate documentation process but ultimately they will take your word on whether or not a tool is suitable.
It is easy to trick an auditor and use an unsuitable tool by creating a large volume of paperwork which falsely explains why it is suitable. If you do this no one will know until or unless the medical device causes harm to someone and your company (or you personally) gets sued or prosecuted and the documents get examined by technical experts appointed by a court.
What you need to think about when you put your signature on the document that states the tool is suitable is whether you could stand up in court and defend your decision after someone has been harmed.
After all this, having said that no tool is ever either inherently suitable or unsuitable, there are some software suppliers that make claims of suitability or even "pre-approval". What this means is that they have pre-written many of the documents that your regulatory submission will require. These are always very expensive (nothing free like googletest fits into this category). Even if you use these pre-written documents, it is your responsibility to review them and put your signature against them and say that they are correct and more importantly that they are applicable to your specific project. Buying a product like this saves you time, but not liability.