What's Behind An ASTM Test Method?

Developing an ASTM standard test method is an arduous process designed to establish a test method for industry while also offering definitive precision, accuracy and reliability (PAR) statements. The (PAR) is based on Precision & Bias (P&B) data achieved through an Inter- Laboratory Study (ILS). An ILS is a mandatory aspect of all ASTM standards that demonstrates how effectively different operators, laboratories and test instruments implement the method, which ultimately defines the precision, accuracy and reliability.

The final ASTM documentation actually states the PAR for that test method, which is very different than ISO, which only describes the method and offers no PAR/P&B data or information regarding the test method’s effective detection capability. In developing ASTM method F2338, PTI can claim that our test systems do not only operate by the ASTM test method but also offer the precision, accuracy and reliability that is recognized by the FDA as a Consensus Standard along with the supporting P&B data. Competitors freely use the F2338 method number in their marketing materials. They can state that they use the method, however until they produce ILS data and definitively establish PAR for their technology claiming to follow F2338, the test method should not be listed as a consensus standard and cannot directly reference the PAR recognized by the FDA as a Consensus Standard.