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 Exclusions:
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.
ASTM D8179-18 Referenced Document
ASTM D1172 Standard Guide for pH of Aqueous Solutions of Soaps and Detergents
ASTM D2024 Standard Test Method for Cloud Point of Nonionic Surfactants
ASTM D3048 Standard Test Method of Assay for Alkaline Protease
ASTM D3519 Standard Test Method for Foam in Aqueous Media (Blender Test)
ASTM D3601 Standard Test Method for Foam In Aqueous Media (Bottle Test)
ASTM D459 Standard Terminology Relating to Soaps and Other Detergents
ASTM D471 Standard Test Method for Rubber Property-Effect of Liquids
ASTM D543 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM D7225 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors*, 2019-05-01 Update
ASTM D820 Standard Test Methods for Chemical Analysis of Soaps Containing Synthetic Detergents*, 2023-07-01 Update
ASTM E2454 Standard Guide for Sensory Evaluation Methods to Determine Sensory Shelf Life of Consumer Products*, 2020-04-01 Update
ASTM F2809 Standard Terminology Relating to Medical and Surgical Materials and Devices*, 2024-04-21 Update
ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments*, 2024-04-21 Update
ASTM F3208 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices*, 2020-07-15 Update
ASTM F3293 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM G122 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
ASTM G31 Standard Practice for Laboratory Immersion Corrosion Testing of Metals
ASTM D8179-18 history
2024ASTM D8179-18(2024) Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
2018ASTM D8179-18 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices