Rationale

This document contains revisions/updates made to the original published test method as part of the 5-year systematic review. Both editorial and technical changes have been made based on input from SMEs including US FDA and NRC-Canada. The equations in this document were converted to images in the process of generating this revisable version from the published version. The equations will be appropriately portrayed in the final publication version so please ignore appearance unless there is an error. We are primarily looking for errors, necessary technical updates and needed clarifications with an intention to avoid major changes to content that has been previously agreed upon by consensus and to avoid changing previously defined terms unless absolutely necessary. Notable additions include 12.14 and 14.1.10.6 to address lot-to-lot or batch-to-batch variation; subclause 3.1.26.1 was incorrectly placed and has been moved and renumbered 3.1.25.1; 3.1.24 term was changed from qualification to performance verification to be internally consistent with use of this term in this standard; table X3.1 was updated to be current; section 15 on Precision and Bias has been replaced with data derived from a 2008 ILS conducted using the same underlying protocol (this is a place holder until a new ILS can be conducted). Main technical changes have also been highlighted in yellow for ease of review.