Unacceptable risk for basic safety prior to or after mitigation?

[Lorenzo]

Hello, everyone,

Unfortunately, I could not find anything in the standard itself. As far as the unacceptable risks are concerned, I am still somewhat confused.

When identifying / defining essential performance, I consider the risks before mitigation. That is so far clear.

What about basic safety? Here the standard also mentions unacceptable risks, but before or after mitigation?
With an electrical device, there is always the danger of an electric shock. So I would always have a Basic Safety for medical electrical devices?

Thank you in advance

 

[Ronen E]

1. For risk and safety definitions and clarifications you should also look in ISO 14971.

2. Basic safety, essential performance and acceptability of risk are dynamic and should be revisited regularly, both before and after mitigation, throughout the device model lifecycle. The picture might change over time as the design changes or more information becomes available (e.g. test results, use feedback etc.) and some elements may move in and out of categories. Note that for a given risk acceptability might change due to change in the frequency/likelihood of occurrence of harm, change in the nature/details of associated harm or change in acceptability criteria.

 

[qualprod]

Hello, everyone,

Unfortunately, I could not find anything in the standard itself. As far as the unacceptable risks are concerned, I am still somewhat confused.

When identifying / defining essential performance, I consider the risks before mitigation. That is so far clear.

What about basic safety? Here the standard also mentions unacceptable risks, but before or after mitigation?
With an electrical device, there is always the danger of an electric shock. So I would always have a Basic Safety for medical electrical devices?

Thank you in advance

You have to evaluate it before and after.when before, according to the risk value, you plan actions, and after have implemented actions evaluate residual risk .
Hope this helps