ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. FDA does not recognize these clauses because it does not satisfy a requirement under the FD&C Act and the requirement encompasses those indicators in commercial distribution for use by hospitals and health care facilities to verify and monitor their sterilization equipment.