ASTM D8179-18
(Guide)Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
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 automated methods for removing soil that accumulate during clinical use. The cleaning solution(s) used are almost always water for rinsing and water with a detergent during washing. AAMI TIR34 (also EN 285) provides guidance about the quality of water to be used during reprocessing. This guidance references various test methods to ensure that water meets the recommended quality.
5.2 When it comes to detergents very little guidance can be found in AAMI, ISO, ASTM, and FDA documents. Further, there are very few consensus methods for evaluating the detergents intended to clean medical devices. The result is that very little detail about detergents, for comparison purposes, is known. As a result, device manufacturers, when authoring their instructions for use (IFU) describe in very generic terms the kind of detergent that can be used to clean their device. Similarly, regulators, also have very little to rely upon for clearing reprocessing instructions. Finally, the healthcare facility, that is ultimately responsible for getting the device clean, has very little detail to assure that one brand of detergent is roughly equivalent to the one used by the medical device manufacturer during validation testing.
5.3 While consensus standard test methods do not exist for detergents intended to clean medical devices, there are dozens of such test methods when it comes to detergents intended to clean dishes, laundry, floors, countertops, and so forth. Many of these methods are under the domain of ASTM D12: Soaps and other Cleaning Agents Including Detergents. While differences certainly do exist, essentially the detergents used for the other purposes are roughly formulated in the same way. Using existing test methods can drive detergent formulation development or determine the need fo...
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 Worl...
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Standards Content (Sample)
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.
Designation: D8179 − 18
Standard Guide for
Characterizing Detergents for the Cleaning of Clinically-
1
used Medical Devices
This standard is issued under the fixed designation D8179; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 Detergents play a critical role in the cleaning of
mendations issued by the World Trade Organization Technical
clinically-used medical devices, but there are few consensus
Barriers to Trade (TBT) Committee.
methods for describing the key characteristics of these deter-
gents. This guide identifies consensus standards, ASTM and
2. Referenced Documents
others, used to characterize detergents in other applications,
2
2.1 ASTM Standards:
which can also be used to characterize detergents used to clean
D459 Terminology Relating to Soaps and Other Detergents
clinically-used medical devices.
D471 Test Method for Rubber Property—Effect of Liquids
1.2 In identifying these test methods, manufacturers of
D543 Practices for Evaluating the Resistance of Plastics to
detergents can reference this guide to characterize their deter-
Chemical Reagents
gents.
D820 Test Methods for Chemical Analysis of Soaps Con-
1.3 By identifying applicable test methods, gaps may be
taining Synthetic Detergents
identified where development of new standardized test meth-
D1172 Guide for pH of Aqueous Solutions of Soaps and
ods need to be developed to characterize detergents intended to
Detergents
clean medical devices.
D2024 Test Method for Cloud Point of Nonionic Surfactants
D3048 Test Method of Assay for Alkaline Protease
1.4 By identifying applicable test methods that are used and
D3519 Test Method for Foam in Aqueous Media (Blender
results reported by detergent manufacturers, test results can be
3
Test) (Withdrawn 2013)
shared and may lead in the future to development of perfor-
D3601 Test Method for Foam In Aqueous Media (Bottle
mance criteria for the key characteristics of detergent.
3
Test) (Withdrawn 2013)
1.5 The values stated in SI units are to be regarded as
D7225 Guide for Blood Cleaning Efficiency of Detergents
standard. No other units of measurement are included in this
and Washer-Disinfectors
standard.
E2454 Guide for Sensory Evaluation Methods to Determine
1.6 Exclusions:
the Sensory Shelf Life of Consumer Products
1.6.1 This guide is not intended for detergents formulated to
F2809 Terminology Relating to Medical and Surgical Mate-
remove residues as a result of the manufacturing process.
rials and Devices
1.6.2 This guide does not provide information related to
F2847 Practice for Reporting and Assessment of Residues
disinfection or disinfecting agents that might be part of a
on Single-Use Implants and Single-Use Sterile Instru-
detergent formulation.
ments
F3208 Guide for Selecting Test Soils for Validation of
1.7 This standard does not purport to address all of the
Cleaning Methods for Reusable Medical Devices
safety concerns, if any, associated with its use. It is the
F3293 Guide forApplication of Test Soils for the Validation
responsibility of the user of this standard to establish appro-
of Cleaning Methods for Reusable Medical Devices
priate safety, health, and environmental practices and deter-
G31 Guide for Laboratory Immersion Corrosion Testing of
mine the applicability of regulatory limitations prior to use.
Metals
1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee D12 on Soaps and contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Other Detergents and is the direct responsibility of Subcommittee D12.15 on Standards volume information, refer to the standard’s Document Summary page on
Physical Testing. the ASTM website.
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Current edition approved Sept. 1, 2018. Published September 2018. DOI: The last approved version of this historical standard is referenced on
10.1520/D8179-18. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D8179 − 18
G122 Test Method for Evaluating the Effectiveness of 3.1.1 cleaning , n—removal of contamination from a medi-
Cle
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