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Significance and Use
5.1 A critical step in preparing a medical device for safe use on the next patient is effective cleaning. Typically cleaning a medical device includes precleaning at the point-of-use, manual and automated methods for removing soil that accumulate during clinical use. The cleaning solution(s) used are almost always water for rinsing and water with a detergent during washing. AAMI TIR34 (also EN 285) provides guidance about the quality of water to be used during reprocessing. This guidance references various test methods to ensure that water meets the recommended quality.
5.2 When it comes to detergents very little guidance can be found in AAMI, ISO, ASTM, and FDA documents. Further, there are very few consensus methods for evaluating the detergents intended to clean medical devices. The result is that very little detail about detergents, for comparison purposes, is known. As a result, device manufacturers, when authoring their instructions for use (IFU) describe in very generic terms the kind of detergent that can be used to clean their device. Similarly, regulators, also have very little to rely upon for clearing reprocessing instructions. Finally, the healthcare facility, that is ultimately responsible for getting the device clean, has very little detail to assure that one brand of detergent is roughly equivalent to the one used by the medical device manufacturer during validation testing.
5.3 While consensus standard test methods do not exist for detergents intended to clean medical devices, there are dozens of such test methods when it comes to detergents intended to clean dishes, laundry, floors, countertops, and so forth. Many of these methods are under the domain of ASTM D12: Soaps and other Cleaning Agents Including Detergents. While differences certainly do exist, essentially the detergents used for the other purposes are roughly formulated in the same way. Using existing test methods can drive detergent formulation development or determine the need for new test methods for medical device cleaning, where or if needed.
1.1 Detergents play a critical role in the cleaning of clinically-used medical devices, but there are few consensus methods for describing the key characteristics of these detergents. This guide identifies consensus standards, ASTM and others, used to characterize detergents in other applications, which can also be used to characterize detergents used to clean clinically-used medical devices.
1.2 In identifying these test methods, manufacturers of detergents can reference this guide to characterize their detergents.
1.3 By identifying applicable test methods, gaps may be identified where development of new standardized test methods need to be developed to characterize detergents intended to clean medical devices.
1.4 By identifying applicable test methods that are used and results reported by detergent manufacturers, test results can be shared and may lead in the future to development of performance criteria for the key characteristics of detergent.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6.1 This guide is not intended for detergents formulated to remove residues as a result of the manufacturing process.
1.6.2 This guide does not provide information related to disinfection or disinfecting agents that might be part of a detergent formulation.
1.7 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.
1.8 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.
D459 Terminology Relating to Soaps and Other Detergents
D471 Test Method for Rubber PropertyEffect of Liquids
D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D820 Test Methods for Chemical Analysis of Soaps Containing Synthetic Detergents
D1172 Guide for pH of Aqueous Solutions of Soaps and Detergents
D2024 Test Method for Cloud Point of Nonionic Surfactants
D3048 Test Method of Assay for Alkaline Protease
D3519 Test Method for Foam in Aqueous Media (Blender Test)
D3601 Test Method for Foam In Aqueous Media (Bottle Test)
D7225 Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
E2454 Guide for Sensory Evaluation Methods to Determine the Sensory Shelf Life of Consumer Products
F2809 Terminology Relating to Medical and Surgical Materials and Devices
F2847 Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
F3208 Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
F3293 Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
G31 Guide for Laboratory Immersion Corrosion Testing of Metals
G122 Test Method for Evaluating the Effectiveness of Cleaning Agents
AAMI DocumentsAAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices AAMI TIR34:2014 Water for the processing of medical devices
ICS Number Code 11.080.20 (Disinfectants and antiseptics)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D8179-18, Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top