Validating Cobalt-60 radiation sterilization in a global marketplace

Full text: A guideline of current stands and their implementation and validation and how they affect product release times to the marketplace is described. The background to write this article is that many times customers are facing problem in selling their products in different countries. For companies selling solely within the U.S. marketplace, compliance with ANSI/AAMI/ISO sterilization standard is sufficient. Any medical devices sold into EU-member countries are required to meet relevant EN sterilization standards. Fortunately, there is a good deal of congruence between ANSI/AAMI/ISO and European standards for radiation sterilization. Several guidelines and standard practices have been developed- and are frequently updated by various organizations. The principal objective of the present article is to outline the various activities that are necessary to qualify sterilization process