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Significance and Use
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 ), 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1193 Specification for Reagent Water
D7225 Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
F2809 Terminology Relating to Medical and Surgical Materials and Devices
F3208 Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
AAMI StandardsAAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities AAMI TIR30
ISO StandardISO 10993-12 Biological evaluation of medical devicesPart 12: Sample preparation and reference materials
Other ReferencesANSI/ASHRAE/ASHE Standard 170-2013 Ventilation of health care facilities; Atlanta: ASHRAE, 2013b https://www.ashrae.org/resources-publications/bookstore/health-care-facilities-resources Guidance for Industry and FDA Staff, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015 www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3293-18, Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top