1.1This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of test soils, as well as incorporation of soils by various means (e.g., actuation of devices) will be described in order to ensure worst-case contamination of the medical devices.
1.2Units-The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3This 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.
1.4This 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.
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