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."

AAMI also reports that ISO and CEN have agreed to revise their standards for ethylene oxide sterilization, moist heat sterilization, and radiation sterilization using ISO 14937 as a template. However, the ISO and CEN will not revise or address specific sterility assurance levels (SALs). In some countries, including the US, a product's SAL depends on its use. In the European Union, all sterile products must have a sterility assurance level of 10-6. The chairman of ISO Technical Committee 198, William Young, said an agreement could not be made on the issue so the setting of SALs will be left to national or regional jurisdictions.