ASTM F 3321 : 2025

1.1This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation. These considerations would also apply when extracting soil from a clinically used device for the purpose of characterizing the clinical soil to inform selection of the simulated use test soil.

1.2This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to apply simulated use test soil(s) to medical devices. This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures. The fourth in the series (Guide F3438) describes methods for testing the recaptured analyte(s) in the test soil to evaluate effectiveness of cleaning procedures.

1.3Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4This 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.

1.5This 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.