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Test Method Validation

"Test Equipment and ASTM Standards"

What is your opinion on using test equipment that does not yet have ASTM Methods?

Last Updated On April 18, 2011

All test methods used for quality verification activities must be validated and documented. Because ASTM test methods have been subjected to properly conducted Inter-Laboratory Studies (ILS), it has been demonstrated that these test methods can be validated and there is statistically determined repeatability and reproducibility information. This information can be used for comparison when conducting your own internal validation, making that process simpler. However, nonstandardized test methods are not precluded from use. If the method that you are planning to use measures the intended attribute, rationale has been established for the selection of the non-standardized test, and the test method has been validated, it is perfectly acceptable to use. The formal validation process must include the determination of the test method’s accuracy; precision, including repeatability (within lab precision) and reproducibility (between lab precision); and range and/or limit of detection.

ISO 11607-2 section 4.3 details the requirements for test method validation, and ASTM E1488 provides guidance for statistical procedures to use in developing and applying test methods.