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Does ISO 13485 cover code required electrical and fire approval such as UL?
Does ISO 13485 cover code required electrical and fire approval such as UL or is this just medical approval?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jun 16, 2021
There is no direct requirement for these codes in ISO 13485: 2016. What is more important, however, is that there is a requirement that the medical device must be safe. Given all possible types of medical devices, different codes will be applicable to each. So if the UL code confirms the safety of your product, then it is very much needed
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