ISTA 2A Partial Simulation Test Performance Test Procedure - attached below
International Safe Transit Association
Sample Size for Medical Device Package Testing
http://www.vanderstahl.com/blog/2010/08/sample-size-for-medical-device-package-testing/
August 2, 2010 | Validation
By Karen Green, CPP
Contributing validation editor
Laura Bix publications: https://www.msu.edu/~bixlaura/publications.html
Fotis, Nick; Taylor, Wayne and Bix, Laura. (October, 2008). "Using hypothesis testing in medical packaging validation." Medical Device and Diagnostic Industry. 30(10)Pp.60-66.
Fotis, Nick and Bix, Laura. (October, 2006). “Sample Size Selection Using a Margin of Error Approach.” Medical Device and Diagnostic Industry.28(10).Pp.80-89.
Gilliland, Dennis; Bix, Laura and Lockhart, Hugh. (October, 2004). Sterile Medical Device Packaging: Statistics and Sample Sizes in Operational Qualifications. Medical Device and Diagnostic Industry. 26(10). Pp.72-77
Bix, Laura and Lockhart, Hugh. (July 9, 2007). “Added Product Complexities Demand Thoughtful Packaging: An Examination of What Packaging can and must do for Medical Products.” 34th Annual Meeting and Exposition of the Controlled Release Society. Long Beach, CA. July 6-11, 2007.
Bix, Laura; Rifon, Nora; Lockhart, Hugh and de la Fuente, Javier. (January-February, 2004). “The Packaging Matrix: Linking Package Design Criteria to the Marketing Mix.” Industry IDS, Inc. Packaging 2004 Conference. http://www.idspackaging.com/indexload.asp. January 19-February 5, 2004.