Alternate radiation methods
Optional Tests for Alternate radiation methods
D-value method validation or dose audit ANSI/AAMI/ISO 11137-2:2006
Method 2 dose audit ANSI/AAMI/ISO 11137-2:2006
A Method 2 Validation, from standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. Method 2 is different from VDmax and Method 1 in that the verification and sterilization dose are based on the microorganism population radiation resistance (you can not fail a Method 2 Validation).
Method 2 radiation validation ANSI/AAMI/ISO 11137-2:2006
A Method 2 Validation, from standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. Method 2 is different from VDmax and Method 1 in that the verification and sterilization dose are based on the microorganism population radiation resistance (you can not fail a Method 2 Validation).

