ASTM F3293-18

Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 This standard 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 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.  
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.  
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.  
1.4 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

• Status: Published
• Publication Date: 30-Apr-2018
• ICS: 11.020.01 - Quality and environmental management in health care
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Refers: ASTM F3208-20 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 15-Jul-2020
• Refers: ASTM F3208-19 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 15-Nov-2019
• Refers: ASTM D7225-13(2019)e1 - Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
• Effective Date: 01-May-2019
• Refers: ASTM F3208-18 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 01-Oct-2018
• Refers: ASTM F3208-17 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 15-Jan-2017
• Refers: ASTM D7225-13 - Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
• Effective Date: 01-Jun-2013
• Refers: ASTM F2809-10 - Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
• Effective Date: 15-Aug-2010
• Refers: ASTM D1193-06 - Standard Specification for Reagent Water
• Effective Date: 01-Mar-2006
• Refers: ASTM D7225-06 - Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
• Effective Date: 01-Feb-2006
• Refers: ASTM D1193-99e1 - Standard Specification for Reagent Water
• Effective Date: 10-Feb-1999
• Refers: ASTM D1193-99 - Standard Specification for Reagent Water
• Effective Date: 10-Feb-1999
• Referred By: ASTM F3321-19 - Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 01-May-2018
• Referred By: ASTM D8179-18 - Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
• Effective Date: 01-May-2018
• Referred By: ASTM F3438-21 - Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 01-May-2018

Overview

ASTM F3293-18 provides guidance for the application of test soils in the validation of cleaning methods for reusable medical devices. Developed by ASTM International, this standard is instrumental in assisting medical device manufacturers to design, validate, and optimize their cleaning instructions to ensure devices are thoroughly cleaned following simulated clinical contamination. The guide covers methods for simulated soiling of medical devices, allowing manufacturers to accurately evaluate the effectiveness of cleaning protocols before regulatory submissions and market distribution.

Reusable medical device cleaning validation is a regulatory and safety priority. Proper implementation of ASTM F3293-18 helps reduce the risk of healthcare-associated infections and ensures compliance with international standards and local regulations.

Key Topics

• Simulated Soiling Methods: The standard outlines practical methods for applying test soils, such as pipetting, brushing, immersing, handling with soiled gloves, spraying, flushing, and vacuum techniques. Each method is selected based on the device’s design and intended clinical use.
• Worst-Case Contamination: Guidance is given for identifying the most inaccessible and hardest-to-clean locations on the device. This ensures validation addresses worst-case scenarios to confirm the adequacy of cleaning procedures.
• Conditioning Considerations: The standard discusses the importance of simulating realistic conditions, including allowing soils to dry for periods reflecting potential real-world delays before cleaning. Parameters such as temperature and humidity should mimic healthcare facility environments.
• Volume and Distribution: Recommendations are made for determining the volume and location of test soil application, ensuring all critical areas-including internal channels and surface crevices-are thoroughly challenged.
• Documentation and Reporting: The standard includes documentation requirements for the validation process, emphasizing the need to record rationale, clinical justifications, soil application methods, and conditions used during validation.

Applications

ASTM F3293-18 is widely used in medical device industries for:

• Validation of Cleaning Instructions: Medical device manufacturers use this guide during the design and development phase to validate instructions for cleaning reusable medical devices, such as surgical instruments, endoscopes, and other critical and semi-critical devices.
• Regulatory Submissions: Conformance with ASTM F3293-18 supports compliance with FDA and international regulatory requirements, forming an essential part of submission dossiers and technical files.
• Device Redesigns and Modifications: When a reusable medical device is redesigned or modified, this standard ensures revised cleaning instructions remain robust and effective against worst-case soiling conditions.
• Risk Management: The standard supports risk management by helping identify locations and device features most susceptible to soil accumulation and potential cleaning failure.
• Training and Internal SOPs: Healthcare facilities and cleaning validation laboratories can use the guide to standardize internal procedures when conducting cleaning validation studies.

Related Standards

Several standards and resources complement or are referenced by ASTM F3293-18, including:

• ASTM F3208 - Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• AAMI TIR30 - Guidance on cleaning processes, materials, and acceptance criteria for reusable medical devices
• AAMI ST79 - Comprehensive guide to steam sterilization and sterility assurance
• ISO 10993-12 - Biological evaluation of medical devices - Sample preparation and reference materials
• ASHRAE/ASHE Standard 170 - Ventilation of healthcare facilities

Implementing ASTM F3293-18 in combination with these related standards empowers manufacturers and healthcare organizations to develop comprehensive validation strategies for reusable medical device cleaning, supporting patient safety and regulatory compliance.

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: F3293 − 18
Standard Guide for
Application of Test Soils for the Validation of Cleaning
Methods for Reusable Medical Devices
This standard is issued under the fixed designation F3293; 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 2.2 AAMI Standards:
AAMI TIR30 A compendium of processes, materials, test
1.1 This guide provides methods and considerations for
methods, and acceptance criteria for cleaning reusable
simulated soiling of reusable medical devices for the purpose
medical devices
of validating cleaning instructions. Techniques for application
AAMIST79 Comprehensiveguidetosteamsterilizationand
of soil, as well as incorporation of soil by various means (e.g.,
sterility assurance in health care facilities
actuation of devices) will be described in order to assure
2.3 ISO Standard:
worst-case contamination of the surface geometry of medical
ISO 10993-12 Biological evaluation of medical devices—
devices.
Part 12: Sample preparation and reference materials
1.2 Units—The values stated in SI units are to be regarded
2.4 Other References:
as standard. No other units of measurement are included in this
ANSI/ASHRAE/ASHE Standard 170-2013 Ventilation of
standard.
health care facilities; Atlanta: ASHRAE, 2013b
1.3 This standard does not purport to address all of the
GuidanceforIndustryandFDAStaff, Processing/Reprocess-
safety concerns, if any, associated with its use. It is the ing Medical Devices in Health Care Settings: Validation
responsibility of the user of this standard to establish appro-
Methods and Labeling, 2015
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accor- 3.1 For definitions of terms in this Guide relating to the use
dance with internationally recognized principles on standard-
of test soils for cleaning validation, refer to the Terminology
ization established in the Decision on Principles for the Section of ASTM F3208.
Development of International Standards, Guides and Recom-
4. Summary of Practice
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
4.1 The standard provides details on the application (inocu-
lation) of the test soil for testing, evaluation, and validation of
2. Referenced Documents
cleaning procedures. It includes:
2.1 ASTM Standards: 4.2 The methods for soiling a medical device.
D1193 Specification for Reagent Water
4.3 The selection of the appropriate method(s) for soiling a
D7225 Guide for Blood Cleaning Efficiency of Detergents
device based upon clinical use of the device.
and Washer-Disinfectors
4.4 Identification of area(s) of the device to soil based upon
F2809 Terminology Relating to Medical and Surgical Mate-
worst-case clinical use and device design.
rials and Devices
F3208 Guide for Selecting Test Soils for Validation of
4.5 Establishingthedwelltimeforthesoileddevice,priorto
Cleaning Methods for Reusable Medical Devices
beginning cleaning procedures, based upon worst-case clinical
conditions/practice.
1 3
This practice/guide is under the jurisdiction of ASTM Committee F04 on Available from Association for the Advancement of Medical Instrumentation
Medical and Surgical Materials and Devices and is the direct responsibility of (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
Subcommittee F04.15 on Material Test Methods. www.aami.org.
Current edition approved May 1, 2018. Published May 2018. DOI: 10.1520/ Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
F3293-18. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or https://www.ashrae.org/resources-publications/bookstore/health-care-facilities-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM resources
Standards volume information, refer to the standard’s Document Summary page on www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guid-
the ASTM website. ancedocuments/ucm253010.pdf
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3293 − 18
4.6 Identification of other worst-case clinical use conditions 8. Determining Clinically Relevant Worst-Case Drying
that represent a worst-case challenge to cleaning the device. Time
These conditions could include the length of the procedure,
8.1 General Considerations:
conditionofthepatient,and/orextraordinaryusesofthedevice
8.1.1 Duration of time for the application of test soil: A
(in compliance with the intended use of the device as estab-
period of time should be established for the duration of the
lished by the medical device manufacturer).
application of soil. The length of time that the test device is
subjected to soiling should reflect worst-case clinical use to
5. Significance and Use
ensure that there is sufficient time to allow contaminants to
5.1 This standard guide may be used by medical device
adhere to and penetrate the device, thereby implementing
manufacturers as part of their design plan and implementation
worst-case soiling to the greatest degree practical.
of the validation of the cleaning instructions of their reusable
8.1.2 If after clinical use of the device, drying of soil might
medical devices.
occur and cleaning might not be performed immediately after
5.2 It may help medical device manufacturers identify the
use (such as with loaner devices that will be shipped without
most inaccessible locations on their device for inoculation with
adequate reprocessing), the validation methods should allow
clinically relevant, simulated-use test soil (see ASTM F3208),
soils to dry for a length of time that simulates worst-case
thereby allowing testing to evaluate whether or not the medical
(longest) duration.
device can be adequately cleaned.
8.1.3 To minimize variability of soiling, consider removing
5.3 Methods described include pipetting, brushing, excess soil after soiling and before drying.
immersing, spraying, handling, and other techniques for apply- 8.1.4 The drying phase could be performed in a number of
ing soil.
ways.Themostcommonapproachistodrythedevicesatroom
temperature (20-25°C) until the devices are not only visually
5.4 Guidance is given as to how to identify the clinically
dry, but to the touch using a gloved hand.Alternative methods
relevantareasofthedevicetosoil,thetimeallowedforthesoil
to test the dryness of the soil include use of a dry cotton swab,
to dry, and other conditioning considerations based upon
toothpick, or similar tools.
assessment of worst-case clinical conditions.
8.1.5 If flaking of soil occurs during drying an alternative
6. Determining the Volume to Soil Each Device
test soil or drying method should be used.
8.1.6 Accelerated drying processes generally do not reflect
6.1 Thevolumeoftestsoilappliedtoadeviceshouldreflect
conditions of normal use and should be avoided. Methods to
worst-case clinical conditions.
accelerate the drying process (elevated temperature, low hu-
6.2 ISO 10993-12 provides formulas for calculating the
midity) may be considered, but may also alter the test soil,
surface-to-area to volume ratios.
rendering it easier to remove.
6.3 AAMI TIR30 provides formulas for calculating the
8.2 TemperatureandHumidity—The test soil should remain
surface area and volume of the internal channel of a device.
on the device/component and be allowed to dry in a tempera-
6.4 Specialattentionshouldbepaidtothevolumeofthekey
ture and humidity range that is similar to that found in
soil markers (see ASTM F3208 for selection of test soil and
healthcare facilities.
soil markers) applied. This should not only reflect worst-case
8.3 Current published guidelines (ASHRAE 170) for envi-
conditions, but also take into account expected recovery
ronmental conditions in areas where a soiled device will dwell
efficiency and the level of detection of the test method.
includetheoperatingtheater,theoperatingroomandprocedure
6.5 The method of application of soil (see Section 9) will
room.
also be a factor in the volume of test soil. For instance, if the
8.4 The length of time allowed for drying should reflect the
entire device is to be immersed in the test soil (section 9.6),
worst-case elapse of time that takes into consideration the time
adequate volume of soil to accomplish this will be required.
betweenpatientuseofth
...