Work Item
ASTM WK92240
New Test Method for Analysis of dose distribution changes in radiation processing using a continuous variable F-test and p-value
1. Scope
1. This test method applies to all irradiator technologies for the analysis of dose distribution following a change to the irradiator. 2. This test method is utilized to assess the impact of the change on the previously qualified processes. 3. This test method utilizes a continuous variable hypothesis test which is used to substantiate the null hypothesis using a p-value. 4. This test method can be utilized by itself or with other methods to determine the impact of a change to an irradiator.Keywords
gamma; ebeam; X-ray; Operational Qualification; Performance Qualification; revalidation; dosimetryRationale
As a requirement in ISO 11137-1, Sterilization of Healthcare Products - Radiation, Part 1, under change control, an evaluation of potential changes to dose distribution is conducted when change activities occur to an irradiator; Historically, change control evaluation of post-change distribution analysis have not been standardized and several methods are non-statistical. This method has been peer-reviewed, published and implemented in industry.
Work Item Status
Date Initiated: 09-10-2024
Technical Contact: John Logar
Item: 000
Ballot:
Status: