Sterilization Standard

ARLINGTON, VA-Panel participants at the AAMI/FDA International Conference on Medical Device Standards and Regulation believe the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) will approve a new standard for sterilization processes this summer. The standard, ISO 14937, covers the development and validation of unique sterilization processes. Drafted to include both existing and future sterilization processes, the Final Approval Ballot of ISO 14937 will begin soon. A previous Enquiry Ballot was unanimously approved, and approval of the final draft is also expected.

Dr. Eamonn Hoxy, the Chairman of CEN TC 204, the European committee responsible for sterilization processing standards, and convener of the ISO working group that drafted the standard stated, "We challenged the requirements at every stage. We asked, will it work for existing processes, will it work for processes that are emerging and for which there isn't any particular standard? This gives us a standard we can use for any process that doesn't have a specific standard or regulation in place."