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ASTM D 8179 : 2018 : R2024

Current

Current

The latest, up-to-date edition.

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

Available format(s)

PDF

Language(s)

English

Published date

18-01-2024

€57.50
Excluding VAT

Committee
D 12
DocumentType
Guide
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

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:

1.6.1This guide is not intended for detergents formulated to remove residues as a result of the manufacturing process.

1.6.2This guide does not provide information related to disinfection or disinfecting agents that might be part of a detergent formulation.

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.

ASTM D 3048 : 1989 : R2016 Standard Test Method of Assay for Alkaline Protease
ASTM F 3293 : 2025 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM D 3048 : 1989 : R2024 Standard Test Method of Assay for Alkaline Protease
ASTM D 459 : 2016 : R2025 Standard Terminology Relating to Soaps and Other Detergents
ASTM D 7225 : 2025 Standard Guide for Evaluating Blood Cleaning Efficiency of Cleaning Agents and Washer-Disinfectors
ASTM D 7225 : 2013 : R2019 : EDT 1 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
ASTM G 31 : 2021 Standard Guide for Laboratory Immersion Corrosion Testing of Metals
ASTM F 3293 : 2018 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM G 31 : 2021 : R2025 Standard Guide for Laboratory Immersion Corrosion Testing of Metals
ASTM D 459 : 2016 Standard Terminology Relating to Soaps and Other Detergents

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€57.50
Excluding VAT