Radiation sterilization, Method 1

Selection of a sterilization dose for a single batch of product ANSI/AAMI/ISO 11137-2:2006

Method 1 dose audit ANSI, AAMI, ISO 11137-2:2006

A Method 1 Validation, or standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. This method validates a range of sterilization doses based on the product's bioburden. This method works well for products with a high bioburden or for products that can not handle a dose as a high as 25.0 kGy because of functionality issues.

Method 1 radiation validation ANSI, AAMI, ISO 11137-2:2006

A Method 1 Validation, or standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. This method validates a range of sterilization doses based on the product's bioburden. This method works well for products with a high bioburden or for products that can not handle a dose as a high as 25.0 kGy because of functionality issues.