The scope of the 1997 edition differentiated between type A and type B sterilizers, where type A were sterilizers, which could be programmed by the user. Type B sterilizers were sterilizers of limited size with one or more pre-set cycles, which could not be varied by the users. Type A was clearly suited for industrial applications and type B was for health care facilities. This differentiation was considered no longer appropriate and was deleted. The standard now applies as well to small units for health care facilities as to very large industrial sterilizers.

In the 2014 revision, an exclusion has been introduced for sterilizers that employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. A similar exclusion was introduced in BS EN ISO 11135:2014.

Moreover, a statement was introduced that this standard is not intended to be applied retrospectively. This indicates that this standard is not intended for older sterilizers, not built to the specifications in this standard, although it can be applied to older sterilizers, if explicitly agreed.