Expert Advice Community

Guest

Does ISO 13485 cover code required electrical and fire approval such as UL?

  Quote
Guest
Guest user Created:   Jun 14, 2021 Last commented:   Jun 16, 2021

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?

0 0

Assign topic to the user

Assign

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jun 14, 2021

Jun 16, 2021