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ASTM D 8179 : 2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

Hardcopy , PDF

Superseded date

23-01-2024

Language(s)

English

Published date

14-09-2018

€67.30
Excluding VAT

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Superseded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

ASTM D 3048 : 1989 : R2016 Standard Test Method of Assay for Alkaline Protease
ASTM D 471 : 2016 : REV A Standard Test Method for Rubber Property—Effect of Liquids
ASTM D 1172 : 1995 Standard Guide for pH of Aqueous Solutions of Soaps and Detergents
ASTM D 3519 : 1988 : R1997 Standard Test Method for Foam in Aqueous Media (Blender Test)
ASTM D 3601 : 1988 : R2007 Standard Test Method for Foam In Aqueous Media (Bottle Test) (Withdrawn 2013)
ASTM D 820 : 1993 : R2016 Standard Test Methods for Chemical Analysis of Soaps Containing Synthetic Detergents
ASTM D 1172 : 1995 : R2001 Standard Guide for pH of Aqueous Solutions of Soaps and Detergents
ASTM F 2809 : 2010 Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
ASTM D 3519 : 1988 : R2002 Standard Test Method for Foam in Aqueous Media (Blender Test)
ASTM F 2847 : 2017 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
ASTM D 2024 : 2009 Standard Test Method for Cloud Point of Nonionic Surfactants
ASTM D 3519 : 1988 : R2007 Standard Test Method for Foam in Aqueous Media (Blender Test) (Withdrawn 2013)
ASTM D 543 : 2021 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
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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