Humidity Control

There is no strict requirements from the ISO 13485:2016 standard about humidity. In requirement 7.5.11 Preservation of the product is descibed that it is organization resposnibility to protect product from alteration, contamination or damage when exposed to expected conditions. 

Therefore, it is manufacturer resposnibility to define under which humidity level medical device must be stored. Usually, this data are obtained during stability study which is one of the main requirement from Medical Device directive.