ABSTRACT
ANSI/AAMI/ISO 11137 incorporates the requirements for the validation of both gamma and electron-beam radiation sterilization. Figure 1 is a schematic that outlines the steps for dose setting using the Method 1 Bioburden Aproach. Method 1 Sterilization Audit https://s3-euw1-ap-pe-df-pch-content-public-p.s3.eu-west-1.amazonaws.com/9780203738306/35982ade-62ef-4b6d-8959-eaf0da700139/content/fig11_1.tif"/>
