ASTM E 3270 : 2021 : EDT 1

1.1This document provides guidance on operational qualification (OQ) tests to meet the OQ requirements defined in ISO 11137-1, ISO 14470, ASTM 51702, and ASTM 52303 for gamma irradiators.

1.2Specific requirements for OQ are dependent on the application of the irradiation process and are not within the scope of this guide. For example, requirements for OQ when sterilizing healthcare products can be found in ISO 11137-1.

1.3A change to the irradiator is a component of the change control process. The OQ testing following the irradiator change is determined as part of the change control documentation and should include rationale to support decision(s) on which tests are required to be completed.

1.4For an OQ study following an irradiator change, the required OQ tests are defined procedurally with established acceptance criteria. (The OQ tests in the appendixes have examples of defined acceptance criteria with a rationale for the acceptance.) When multiple tests are used in the assessment of change, no individual OQ test should be solely relied upon; rather, the composite of OQ test results should be used to help provide a clear justification for the conclusion regarding irradiator change.

1.5Many calculations in this guide were completed using Microsoft Excel (for example, ANOVA, t-test, p-value), but numerous other software tools are commercially available.

1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.