What I’m sharing right now is ASTM F3208-17,Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.Thank Coco from Australia for her generous sharing.
ASTM F3208-17 describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.
This guide provides information on the selection of test soil formulation(s) based upon clinical use and physical characteristics of clinically occurring soiling of the device.
This guide provides the sample preparation technique for some test soils that simulate the soils found on medical devices as a result of clinical use.
An important aspect of the cleaning validation is deter-mining the appropriate test soil(s) used to contaminate the device.
The manufacturer of the medical device or the repro-cessing equipment shall justify why the specific soil(s) was chosen and is appropriate for all cleaning markers/assays to be measured.
General Discussion—Test soils may be characterized based upon various physical properties. These properties can be used to compare one test soil to another. More importantly,these properties may be used to compare a test soil to the actual clinical contaminants (or contamination) found on a clinically used medical device. This may further help demonstrate theappropriate selection of a test soil for a given device.
ASTM F3208-17 pdf download
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