【国外标准】 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

5.1 This standard 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 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 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.1.4 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.