Ionizing radiation doc

In the procedure 12.4 Procedure for ionizing radiation sterilization, you need to fulfill only elements that are marked with comments. Of course, your data depends on your specific process of radiation, and only you know which they are (for example in section 3.4 Alara Principle).

If you have anything else that you consider important, of course, that you can add to the procedure.

If your sterilization process is outsourced, take into consideration to make this procedure in collaboration with the company that provides this process for you.

For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following article:

• Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/