scope:

This standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. The two categories of sterilizer have been designated Type A and Type B respectively using the following criteria: - Type A sterilizers are capable of being programmed by the user; - Type B sterilizer are of limited size and provided with one or more pre-set operating cycles which cannot be varied by the user. This standard includes minimum performance and construction requirements for sterilizers working above or below atmospheric pressure: - to ensure that the process is capable of being used to sterilize medical products; - for the equipment and controls necessary to permit validation of the sterilization process; - for sterilizers intended primarily for use in healthcare facilities (hospitals, clinics, etc.).