1.1Detergents 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.

1.2In identifying these test methods, manufacturers of detergents can reference this guide to characterize their detergents.

1.3By 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.

1.4By 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.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6Exclusions:

1.7This 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.

1.8This 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.