ASTM F3321-19
(Guide)Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
SIGNIFICANCE AND USE
5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.
5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.
5.3 Methods describing various techniques for extracting soil are given.
5.4 Guidance is further given as to how to validate the method(s) for extraction.
SCOPE
1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process.
1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures.
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
1.5 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.
General Information
Relations
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: F3321 − 19
Standard Guide for
Methods of Extraction of Test Soils for the Validation of
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Cleaning Methods for Reusable Medical Devices
This standard is issued under the fixed designation F3321; 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 Direct Current Plasma Atomic Emission Spectrometry
E2314 Test Method for Determination of Effectiveness of
1.1 This guide provides methods and considerations for
Cleaning Processes for Reusable Medical Instruments
extracting test soil(s) from reusable medical device(s) that
Using a Microbiologic Method (Simulated Use Test)
occurs during simulated use validation, clinical use of the
E2520 Practice for Measuring and Scoring Performance of
device(s) and after the device(s) have been through a cleaning
Trace Explosive Chemical Detectors
process.
F619 Practice for Extraction of Medical Plastics
1.2 This is a part of a series ofASTM guides for validating
F2459 Test Method for Extracting Residue from Metallic
cleaning instructions. The scope of the first guide in the series
Medical Components and Quantifying via Gravimetric
is regarding selecting appropriate test soils (Guide F3208).The
Analysis
second in the series (Guide F3293) describes methods that are
F3127 GuideforValidatingCleaningProcessesUsedDuring
used to inoculate medical devices with simulated-use test
the Manufacture of Medical Devices
soil(s).This third in the series describes methods for extracting
F3208 Guide for Selecting Test Soils for Validation of
test soils in order to measure residual soil remaining on
Cleaning Methods for Reusable Medical Devices
medical devices after the performance of cleaning procedures.
F3293 Guide forApplication of Test Soils for the Validation
of Cleaning Methods for Reusable Medical Devices
1.3 Units—The values stated in SI units are to be regarded
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as standard. No other units of measurement are included in this 2.2 AAMI Documents:
AAMI TIR17 Compatibility of materials subject to steriliza-
standard.
tion
1.4 This standard does not purport to address all of the
AAMI TIR30 A compendium of processes, materials, test
safety concerns, if any, associated with its use. It is the
methods, and acceptance criteria for cleaning reusable
responsibility of the user of this standard to establish appro-
medical devices
priate safety, health, and environmental practices and deter-
ANSI/AAMI/ISO 15883-1 Washer-disinfectors – Part 1:
mine the applicability of regulatory limitations prior to use.
General requirements, terms and definitions and tests
1.5 This international standard was developed in accor-
2.3 FDA Document:
dance with internationally recognized principles on standard-
FDA Guidance for Industry and FDA Staff, Processing/
ization established in the Decision on Principles for the
Reprocessing Medical Devices in Health Care Settings:
Development of International Standards, Guides and Recom-
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Validation Methods and Labeling, June 6, 2017
mendations issued by the World Trade Organization Technical
2.4 Other Documents:
Barriers to Trade (TBT) Committee.
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EPA, SW-846 Test Method 3540C Soxhlet Extraction
Evotech® endoscope cleaner and reprocessor (ECR) simu-
2. Referenced Documents
lated use and clinical use evaluation of cleaning efficacy,
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2.1 ASTM Standards:
BMC Infectious Diseases 201010:200, Alfa, M.J.,
E1097 Guide for Determination of Various Elements by
DeGagne, P., Olson, N, Fatima, I . 2010
3. Terminology
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and
3.1 Definitions:
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
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Current edition approved Oct. 1, 2019. Published October 2019. DOI: 10.1520/ Available from Association for the Advancement of Medical Instrumentation
F3321-19. (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or www.aami.org.
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/
Standards volume information, refer to the standard’s Document Summary page on guidancedocuments/ucm253010.pdf
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the ASTM website. https://www.epa.gov/hw-sw846/sw-846-test-method-3540c-soxhlet-extraction
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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