Validating test methods

However, even more important is choosing a method of measuring the correct property or characteristic.

Not all tests and measurements are equally useful: usually a test result is used to predict or imply suitability for a certain purpose.

Using a standardized test method, perhaps published by a respected standards organization, is a good place to start.

Sometimes it is more useful to modify an existing test method or to develop a new one, though such home-grown test methods should be validated A well-written test method is important.

ISO 11607, TIR 22, and ASTM all help manufacturers understand their package testing responsibilities.

Any medical device package test that is used to support conformance with ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices—Part 1 and Part 06, must be validated.

Doing so enables us to use standardized test methods in our research projects.“If you follow ISO 11607, an FDA consensus document, and use the test methods in the annex, you don’t have to create your own rationale as to why another test is appropriate,” explains Jackie Daly Johnson, president of Beacon Converters (Saddle Brook, NJ) and cochair of the AAMI Sterilization Packaging Working Group, which developed TIR 22.“You don’t have to reinvent the wheel every time.”Many of the methods listed in the annex have been recognized by FDA as consensus standards.While not a new concept, test method validation continues to challenge packaging professionals throughout the industry.According to section 4.4.1 of ISO 11607, “all test methods used to show compliance with this part of ISO 11607 shall be validated and documented.” AAMI Technical Information Report (TIR) 07, reiterates the point in 5.2.1: “All test methods must be validated.” ISO 11607 and TIR 22 then point users to Annex B’s list of “suitable test methods.”So are the methods of Annex B all you need?

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It is common for a physical property to be strongly affected by the precise method of testing or measuring that property.

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