ASTM D 8179 : 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
Hardcopy , PDF
01-23-2024
English
09-14-2018
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.
Committee |
D 12
|
DocumentType |
Guide
|
Pages |
5
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
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.
ANSI/AAMI/ISO 17664-2:2022 | Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices |
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ASTM D 1172 : 2015 : R2024 | Standard Guide for pH of Aqueous Solutions of Soaps and Detergents |
ASTM D 2024 : 1965 : R1997 | Standard Test Method for Cloud Point of Nonionic Surfactants |
ASTM D 2024 : 1965 : R2003 | Standard Test Method for Cloud Point of Nonionic Surfactants |
ASTM D 471 : 2016 : REV A : R2021 | Standard Test Method for Rubber Property—Effect of Liquids |
ASTM F 3208 : 2017 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
ASTM D 3048 : 1989 : R1995 : EDT 1 | Standard Test Method of Assay for Alkaline Protease |
ASTM D 1172 : 2015 | Standard Guide for pH of Aqueous Solutions of Soaps and Detergents |
ASTM D 7225 : 2013 : R2019 : EDT 1 | Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors |
ASTM F 2847 : 2010 | Standard Practice for Reporting and Assessment of Residues on Single Use Implants |
ASTM G 31 : 2021 | Standard Guide for Laboratory Immersion Corrosion Testing of Metals |
ASTM E 2454 : 2019 : REV A | Standard Guide for Sensory Evaluation Methods to Determine the Sensory Shelf Life of Consumer Products |
ASTM D 543 : 2020 | Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents |
ASTM E 2454:2005 | Standard Guide for Sensory Evaluation Methods to Determine the Sensory Shelf Life of Consumer Products |
ASTM D 820 : 1993 : R2023 | Standard Test Methods for Chemical Analysis of Soaps Containing Synthetic Detergents |
ASTM F 3208 : 2019 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
ASTM F 3208 : 2018 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
ASTM F 3293 : 2018 | Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
ASTM D 2024 : 2009 : R2023 | Standard Test Method for Cloud Point of Nonionic Surfactants |
ASTM D 1172 : 1995 : R2007 | Standard Guide for pH of Aqueous Solutions of Soaps and Detergents |
ASTM D 7225 : 2013 | Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors |
ASTM D 3601 : 1988 : R1997 | Standard Test Method for Foam In Aqueous Media (Bottle Test) |
ASTM E 2454 : 2005 : R2011 | Standard Guide for Sensory Evaluation Methods to Determine the Sensory Shelf Life of Consumer Products |
ASTM E 2454 : 2019 | Standard Guide for Sensory Evaluation Methods to Determine the Sensory Shelf Life of Consumer Products |
ASTM D 2024 : 2009 : R2017 | Standard Test Method for Cloud Point of Nonionic Surfactants |
ASTM D 7225 : 2006 | Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors |
ASTM D 3601 : 1988 : R2002 : EDT 1 | Standard Test Method for Foam In Aqueous Media (Bottle Test) |
ASTM E 2454 : 2020 | Standard Guide for Sensory Evaluation Methods to Determine Sensory Shelf Life of Consumer Products |
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