Hello all,
I work in the medical device field, and I am looking for some information that is difficult to find. As many of you may know, there are multiple techniques available for analysing tolerances. My problem is that I need objective evidence to show that the method I am using is accepted for use with medical devices.
More specifically I would like to see an ISO standard that says this method is an accepted way of doing a tolerance stack. The method I'm using is called the Root Sum Square (RSS) method. I am aware that this method can be used in conjunction with 6 sigma approaches, but I'm not sure if RSS can be used by itself.
Rather than explaining what methods are better or worse, I would like to find objective evidence as to what method is appropriate for the medical device industry. Does anyone know of a resource where I can find such an iso standard.