62304 software will always fail?

Myron Kilback asked a question: 62304 software will always fail?
Asked By: Myron Kilback
Date created: Wed, May 26, 2021 3:45 PM
Date updated: Tue, Jan 25, 2022 11:55 PM



Those who are looking for an answer to the question «62304 software will always fail?» often ask the following questions:

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9 other answers

In the case of software failures generated by defects, the probability of defects is unknown. The purpose of IEC 62304 is to decrease the probability with more strigent development methods according to the class of software. Risks related to these software failures, however, will still be present.

Now two possibilities: a) if we treat Thermal Cutout as extremely reliable and has 1 in 1000000 failure rate, then the answer is No, so according to Figure 3, our software is class A. b) if we treat Thermal Cutout to be reasonable reliable e.g. 1 in 1000 failure rate, then the answer is Yes so go to 4)

You need to do the following if you choose to use IEC 62304: there must be tests cases for the software requirements; you need to manage issues found during testing; you need to do regression tests after changes; you need verify that the testing approach is good (e.g. that there is a complete and documented traceability to software requirements)

The IEC 62304 medical device software standard (“Medical device software—Software life cycle processes”) is comprised of five processes in five chapters (5-9): 5 – Software Development Process = this is the main process that SW groups are focused on and includes all the key aspects of development from planning and requirements to ...

This is one area where IEC 62304 is weakly structured: if a serious incident occurred and the cause found that Feature B interfered with Feature A, there is no record required by the standard which clearly identifies the responsible person that decided not to re-test Feature A again in V1.0.1.4.

For medical devices containing software, the software must be developed according to IEC 62304. The processes put forth by IEC 62304 are really established best practices in the software industry, most of which can be followed for both medical and non-medical projects. The standard does not prescribe a particular life cycle model or ...

We have already mentioned two pitfalls in agile software development for medical products: The document approvals are not done in a IEC 62304 compliant way or increase rather than decrease the overhead. The software architecture is retrospectively or poorly developed and / or documented.

The wording of BS EN 62304 has contributed to wide-spread concern about how to handle the probability of software failure and treatment of risks, if probability of failure should be considered at 100%. This stems from the guidance wording in Annex B 4.3 that states:

One of the more controversial requirements of IEC 62304 is the probability of failure of medical device software during Risk Analysis. EN 62304:2006 paragraph 4.3 “Software Safety Classification” states “If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the probability of such failure shall be assumed to be 100 percent.”

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