Palvelualojen työnantajat PALTA

 

This document specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of a specified sterilization dose to achieve an SAL of 10-6. This document also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This document defines product families for sterilization dose establishment and sterilization dose audit.