ASTM F3321-19

5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.

5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.

5.3 Methods describing various techniques for extracting soil are given.

5.4 Guidance is further given as to how to validate the method(s) for extraction.

1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process.

1.2 This 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 inoculate medical devices with simulated-use test soil(s). 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.

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

1.4 This 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.

1.5 This 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.