ASTM International - ASTM D8179-18

Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices

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Organization: ASTM International
Publication Date: 1 September 2018
Status: active
Page Count: 5
ICS Code (Disinfectants and antiseptics): 11.080.20
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... View More

scope:

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.

Document History

ASTM D8179-18
September 1, 2018
Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
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...
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