ASTM D8179-18(2024)

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...

General Information

• Status: Published
• Publication Date: 31-Dec-2023
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: D12 - Soaps and Other Detergents
• Drafting Committee: D12.15 - Physical Testing

Relations

• Replaces: ASTM D8179-18 - Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
• Effective Date: 01-Jan-2024

Overview

ASTM D8179-18(2024), Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices, provides essential guidance for stakeholders involved in the cleaning and reprocessing of medical devices. Effective cleaning is critical for patient safety and reliable device performance. While the water quality aspects of cleaning are well addressed in international guidance, there is a notable lack of consensus methods for evaluating and characterizing detergents formulated for cleaning clinically-used medical devices. This standard fills a major gap by identifying test methods and guiding industry stakeholders-such as detergent manufacturers, medical device manufacturers, and healthcare facilities-in the characterization of detergents for safe and effective medical device cleaning.

Key Topics

• Significance of Detergent Characterization: The guide highlights the pivotal role of detergents in removing clinical soils during the cleaning process. Detergents must reliably remove biological soils before disinfection and sterilization, but specifications for medical device detergents are often vague due to limited standardized evaluation methods.
• Consensus Testing Methods: ASTM D8179 references numerous test methods from ASTM and other international standards commonly used in other cleaning applications (e.g., institutional, household) that can be adapted for medical device detergent evaluation.
• Critical Evaluation Parameters: The standard identifies several key characteristics for evaluating detergents, including:
  • Soil removal efficiency
  • Foaming behavior
  • Material compatibility (metals, plastics, rubber)
  • Rinsability and residue
  • Biodegradability and environmental safety
  • Toxicity at use-dilution
  • Stability and shelf-life
  • pH and solubility in water
  • Enzyme activity (if applicable)
• Test Soil Guidance: The document provides direction in selecting and applying relevant test soils to simulate clinical contaminants for validation purposes.
• Identification of Gaps: By using referenced methods, the standard helps reveal where new or modified testing approaches are needed for detergents specifically used in medical device cleaning.

Applications

ASTM D8179-18(2024) serves multiple practical purposes:

• Detergent Manufacturer Reference: Enables formulation development and evidence-based product claims by referencing established test methods for key performance attributes.
• Medical Device Manufacturers: Supports the development of detailed, validated instructions for use (IFU) regarding cleaning protocols and acceptable detergents, aiding regulatory submissions and device clearances.
• Healthcare Facilities: Assists in choosing and validating detergents that are demonstrably effective, safe, and equivalent to products used in device validation.
• Regulatory Compliance and Quality Assurance: Helps manufacturers and healthcare providers document cleaning efficacy for regulatory bodies, providing assurance for both existing and new cleaning agents.
• Industry Standardization: Lays a foundation for future development of consensus performance criteria for detergents used in medical cleaning applications.

Related Standards

Several referenced documents and standards are integral to ASTM D8179, such as:

• ASTM Standards: D459 (Terminology), D471 (Rubber Resistance), D543 (Plastics Resistance), D1172 (pH Measurement), D820 (Chemical Analysis), D3048 (Enzyme Assay), D7225 (Blood Cleaning Efficiency), F3208/F3293 (Test Soils and Application).
• AAMI Guidance: TIR12, TIR30, TIR34, ST79-guidance on device cleaning and water quality.
• ISO Standards: ISO 7827 (Water Quality-Biodegradability), ISO 10993-5/-12 (Biological Evaluation), ISO/TS 15883-5 (Cleaning Efficacy).
• OECD Guidance: OECD 105, 301, 310 (Biodegradability and Solubility Testing)
• Other Relevant Methods: CSPA DCC-15 (Surface Abrasion), EPA "Six Pack" Toxicity Testing, EN 285 (Steam Sterilizers).

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Keywords: ASTM D8179, medical device detergents, detergent characterization, cleaning efficacy, medical device reprocessing, cleaning validation, consensus standards.

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 (Reapproved 2024)
Standard Guide for
Characterizing Detergents for the Cleaning of Clinically-
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 1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 Detergents play a critical role in the cleaning of
ization established in the Decision on Principles for the
clinically-used medical devices, but there are few consensus
Development of International Standards, Guides and Recom-
methods for describing the key characteristics of these deter-
mendations issued by the World Trade Organization Technical
gents. This guide identifies consensus standards, ASTM and
Barriers to Trade (TBT) Committee.
others, used to characterize detergents in other applications,
which can also be used to characterize detergents used to clean
2. Referenced Documents
clinically-used medical devices.
2.1 ASTM Standards:
1.2 In identifying these test methods, manufacturers of
D459 Terminology Relating to Soaps and Other Detergents
detergents can reference this guide to characterize their deter-
D471 Test Method for Rubber Property—Effect of Liquids
gents.
D543 Practices for Evaluating the Resistance of Plastics to
1.3 By identifying applicable test methods, gaps may be
Chemical Reagents
identified where development of new standardized test meth- D820 Test Methods for Chemical Analysis of Soaps Con-
ods need to be developed to characterize detergents intended to
taining Synthetic Detergents
clean medical devices. D1172 Guide for pH of Aqueous Solutions of Soaps and
Detergents
1.4 By identifying applicable test methods that are used and
D2024 Test Method for Cloud Point of Nonionic Surfactants
results reported by detergent manufacturers, test results can be
D3048 Test Method of Assay for Alkaline Protease
shared and may lead in the future to development of perfor-
D3519 Test Method for Foam in Aqueous Media (Blender
mance criteria for the key characteristics of detergent.
Test) (Withdrawn 2013)
1.5 The values stated in SI units are to be regarded as
D3601 Test Method for Foam In Aqueous Media (Bottle
standard. No other units of measurement are included in this 3
Test) (Withdrawn 2013)
standard.
D7225 Guide for Blood Cleaning Efficiency of Detergents
1.6 Exclusions: and Washer-Disinfectors
E2454 Guide for Sensory Evaluation Methods to Determine
1.6.1 This guide is not intended for detergents formulated to
Sensory Shelf Life of Consumer Products
remove residues as a result of the manufacturing process.
F2809 Terminology Relating to Medical and Surgical Mate-
1.6.2 This guide does not provide information related to
rials and Devices (Withdrawn 2019)
disinfection or disinfecting agents that might be part of a
F2847 Practice for Reporting and Assessment of Residues
detergent formulation.
on Single-Use Implants and Single-Use Sterile Instru-
1.7 This standard does not purport to address all of the
ments
safety concerns, if any, associated with its use. It is the
F3208 Guide for Selecting Test Soils for Validation of
responsibility of the user of this standard to establish appro-
Cleaning Methods for Reusable Medical Devices
priate safety, health, and environmental practices and deter-
F3293 Guide for Application of Test Soils for the Validation
mine the applicability of regulatory limitations prior to use.
of Cleaning Methods for Reusable Medical Devices
1 2
This guide is under the jurisdiction of ASTM Committee D12 on Soaps and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Other Detergents and is the direct responsibility of Subcommittee D12.15 on contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Physical Testing. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 1, 2024. Published January 2024. Originally the ASTM website.
approved in 2018. Last previous edition approved in 2018 as D8179 – 18. DOI: The last approved version of this historical standard is referenced on
10.1520/D8179-18R24. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8179 − 18 (2024)
G31 Guide for Laboratory Immersion Corrosion Testing of 3. Terminology
Metals
3.1 Definitions:
G122 Test Method for Evaluating the Effectiveness of
3.1.1 cleaning , n—removal of contamination from a medi-
Cleaning Agents and Processes
cal device to the extent necessary for further processing of or
2.2 AAMI Documents: for intended use.
AAMI TIR12:2010 Designing, testing, and labeling reusable
3.1.2 detergents, n—a composition that removes soil. D459
medical devices for reprocessing in health care facilities:
3.1.3 disinfection, n—destruction or reduction of patho-
A guide for medical device manufacturers
genic and other kinds of microorganisms by thermal or
AAMI TIR30:2011 A compendium of processes, materials,
chemical means.
test methods, and acceptance criteria for cleaning reusable
3.1.4 medical device, n—any instrument, apparatus,
medical devices
implement, machine, appliance, implant, in vitro reagent or
AAMI TIR34:2014 Water for the processing of medical
calibrator, software, material, or other similar or related article
devices
intended by the manufacturer to be used, alone or in
AAMI ST79:2017 Comprehensive guide to steam steriliza-
combination, for human beings for one or more of the specific
tion and sterility assurance in health care facilities
purpose(s) of: (1) diagnosis, prevention, monitoring, treatment,
2.3 ISO Standards:
or alleviation of disease, (2) diagnosis, monitoring, treatment,
ISO 7827:2010 Water quality – Evaluation of the “ready”,
alleviation of, or compensation for an injury, (3) investigation,
“ultimate” aerobic biodegradability of organic compounds
replacement, modification, or support of the anatomy or of a
in aqueous medium – Method by analysis of dissolved
physiological process, (4) supporting or sustaining life, (5)
organic carbon (DOC)
control of conception, (6) disinfection of medical devices, and
ISO 10993-5:2009 Biological evaluation of medical devices
(7) providing information for medical purposes by means of in
– Part 5: Tests for in vitro cytotoxicity
vitro examination of specimens derived from the human body
ISO 10993-12:2009 Biological evaluation of medical de-
and which does not achieve its primary intended action in or on
vices – Part 12: Sample preparation and reference mate-
the human body by pharmacological, immunological, or meta-
rials
bolic means, but which may be assisted in its function by such
ISO/TS 15883-5:2005 Washer-disinfectors – Part 5: Test
means. F2809
soils and methods for demonstrating cleaning efficacy
3.1.5 shelf-life, n—the length of time recommended by the
2.4 Other Documents:
manufacturer, based upon testing, that a detergent may be fit
CSPA: DCC-15:2011 Cleaning Test Method DCC-15 Guide-
for use after the date of manufacture.
lines for Measuring Degree of Surface Abrasion
EN 285:2015 Sterilization – Steam Sterilizers – Large Ster-
4. Summary of Guide
ilizers
4.1 General Considerations—This guide identifies ASTM
EPA Test Guidelines for Pesticide Data Requirements “six
and other consensus test methods to assess the characteristics
pack tox testing”
of detergent cleaning agents intended for use when cleaning
FDA Reprocessing Medical Devices in Health Care Set-
clinically used medical instruments and devices. Detergents are
tings: Validation Methods and Labeling/Guidance for
defined in 3.1.2 consistent with the ASTM D12 Terminology
Industry and Food and Drug Administration Staff (Docu-
Guide. Detergents are made up of a system of cleaning agents
ment updated on June 9, 2017)
with no one component solely responsible for its performance.
OECD 105:1995 Water Solubility
Appropriate test methods may address components or the
OECD 301:1992 Test No 301: Ready Biodegradability
finished product, or both.
OECD 310:2006 Test No. 310: Ready Biodegradability -
4.1.1 As a starting point this guide identifies useful test
CO in sealed vessels (Headspace Test)
methods based on the list of characteristics for “ideal cleaning
agents” identified in AAMI TIR 12 (Section 4.2.4.3, Cleaning
Agents) and in AAMI ST79 (Section 7.6.3, Cleaning): non-
Available from Association for the Advancement of Medical Instrumentation
abrasive; compatible with the medical device or container
(AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633,
system to be cleaned as well as the materials used in the
http://www.aami.org.
5 cleaning equipment itself; low-foaming; free-rinsing (that is,
Available from International Organization for Standardization (ISO), ISO
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
easily removed from the medical device); biodegradable;
Geneva, Switzerland, http://www.iso.org.
provides for soil dispersion or suspension; rapidly dissolve(s)/
Available from Household & Commercial Products Association,
disperse(s) soil; is effective on clinically relevant soils under
https://member.thehcpa.org.
specified use conditions; is non-toxic in the specified use
Available from European Committee for Standardization (CEN), Avenue
Marnix 17, B-1000, Brussels, Belgium, http://www.cen.eu.
dilution; has a shelf life and use-life consistent with the
Available from United States Environmental Protection Agency (EPA), William
anticipated clinical use; is cost-effective.
Jefferson Clinton Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460,
http://www.epa.gov.
4.2 The following factors are a framework for identifying
Available from U.S. Food and Drug Administration (FDA), 10903 New
test methods that will be helpful to characterize detergent
Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
cleaning agents intended for use when cleaning clinically-used
Available from the online library of the Organisation for Economic Coopera-
tion and Development (OECD), www.oecd-ilibrary.org. medical instruments and devices.
D8179 − 18 (2024)
4.2.1 The stage of the cleaning process. For example, test 5.3 While consensus standard test methods do not exist for
methods for pre-treatment agents may need different test detergents intended to clean medical devices, there are dozens
methods than automated machine-washing products. of such test methods when it comes to detergents intended to
clean dishes, laundry, floors, countertops, and so forth. Many
4.2.2 The method of cleaning. Manual or automated pro-
cesses and related levels of impingement and physical actions of these methods are under the domain of ASTM D12: Soaps
and other Cleaning Agents Including Detergents. While differ-
may impact test methods. For example, test methods to
measure foaming and viscosity may be useful. ences certainly do exist, essentially the detergents used for the
other purposes are roughly formulated in the same way. Using
4.2.3 Testing for substrate material compatibility. For
existing test methods can drive detergent formulation develop-
example, stainless steel, aluminum, glass optics and various
plastics are commonly used in medical devices. ment or determine the need for new test methods for medical
device cleaning, where or if needed.
4.2.4 Identification of clinically relevant test soils and soil
application methods.
6. Applicable Test Methods for Characterizing
4.2.5 Effective soil removal. For example, identification and
Detergents Intended to Clean Medical Devices
measurement of soil removal via emulsification and saponifi-
cation at specified dosing or dilution points.
6.1 Measure Abrasion (DCC-15 – Surface Abrasive
4.2.6 Water quality and temperature during cleaning. For
Cleaners)—Consumer Specialty Product Association (CSPA)
example, the measurement of performance for conditioning
guideline for measuring degree of surface abrasion by abrasive
and softening action at a stated water condition may be useful.
cleaners. This is a guideline and not a performance test
4.2.7 Effective enzyme performance when these agents are allowing for meaningful modifications. While this test is from
part of the formula.
a consumer products test group, the fact that it is a guideline
and not a standard should allow for some flexibility.
4.2.8 Dispersion and suspension of soils away from sub-
strate surfaces.
6.2 Material Compatibility (G31, D543, D471)—Guide G31
4.2.9 Free-rinsing as measured by the ease of the elimina-
is a standard guide that can be used by those designing
tion of residuals and spotting.
immersion tests designed to evaluate the chemical resistance of
4.2.10 Solubility of detergents into water for consistent
metals to cleaning detergents. Modern medical devices are
dosing effect.
made from, but not limited to, stainless steel, titanium, chrome-
4.2.11 Stability of detergents.
plated, and brass. Thus, it is very important to design corrosion
4.2.12 Biological effects and human factors for detergents.
experiments to be compatible with a wide range of metals as
For example, it is desirable to accomplish cleaning action with
corrosion rates can differ due to material type. The guide also
regard for the protection of the environment and safety of
provides information on interpretation of corrosion data and
workers, respectively.
how to calculate rate of corrosion. Materials used in the
manufacturing of medical devices are not limited to metals.
5. Significance and Use
Many devices also have plastic and rubber components that
must also be tested for compatibility with cleaning detergents.
5.1 A critical step in preparing a medical device for safe use
Practices D543 describe methods for evaluating the resistance
on the next patie
...