ASTM F3438-24

Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) 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 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 This guide describes various test methods for the different analytes.  
5.4 This guide specifies the validation criteria for analyte detection methods.
SCOPE
1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.  
1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.  
1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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: 14-Mar-2024
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: 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: 15-Mar-2024

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: F3438 − 24
Standard Guide for
Detection and Quantification of Cleaning Markers (Analytes)
for the Validation of Cleaning Methods for Reusable Medical
1
Devices
This standard is issued under the fixed designation F3438; 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This standard guide provides methods and consider-
Barriers to Trade (TBT) Committee.
ations for detecting and quantifying test soil(s) from reusable
medical device(s) that result from simulated-use testing of
2. Referenced Documents
medical devices during validation of the cleaning procedures as
2
2.1 ASTM Standards:
described in the instructions for use (IFU) provided by the
D7573 Test Method for Total Carbon and Organic Carbon in
medical device manufacturer.
Water by High Temperature Catalytic Combustion and
1.2 The methods described are for detecting and measuring
Infrared Detection
markers (analytes) that are components within the most com-
E1097 Guide for Determination of Various Elements by
mon test soils and are relevant to the clinical use of the device.
Direct Current Plasma Atomic Emission Spectrometry
Appropriate test soils without protein, carbon, or carbohydrates
E2520 Practice for Measuring and Scoring Performance of
(for example, bone) will require other methods.
Trace Explosive Chemical Detectors
F3127 Guide for Validating Cleaning Processes Used During
1.3 This is a part of a series of ASTM standard guides for
validating cleaning instructions. The scope of the first guide in the Manufacture of Medical Devices
F3208 Guide for Selecting Test Soils for Validation of
the series is selecting appropriate test soils (Guide F3208). The
second in the series (Guide F3293) describes methods for Cleaning Methods for Reusable Medical Devices
F3293 Guide for Application of Test Soils for the Validation
inoculating medical devices with test soil. The third in the
series (Guide F3321) describes methods for extracting soils for of Cleaning Methods for Reusable Medical Devices
measuring residual soil on medical devices after the perfor- F3321 Guide for Methods of Extraction of Test Soils for the
mance of cleaning process. This is the fourth guide in the series Validation of Cleaning Methods for Reusable Medical
and describes the methods of detecting and quantifying re- Devices
3
sidual analytes on the device. 2.2 AAMI Documents:
AAMI TIR12 Designing, testing, and labeling reusable
1.4 Units—The values stated in SI units are to be regarded
medical devices for reprocessing in health care facilities:
as standard. No other units of measurement are included in this
A guide for medical device manufacturers
standard.
AAMI ST98 Cleaning validation of health care products—
1.5 This standard does not purport to address all of the
Requirements for development and validation of a clean-
safety concerns, if any, associated with its use. It is the
ing process for medical devices
responsibility of the user of this standard to establish appro- 4
2.3 ISO Standard:
priate safety, health, and environmental practices and deter-
ISO 15883-5 Washer-disinfectors—Part 5: Performance re-
mine the applicability of regulatory limitations prior to use.
quirements and test method criteria for demonstrating
1.6 This international standard was developed in accor-
cleaning efficacy
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available from Association for the Advancement of Medical Instrumentation
F04.15 on Material Test Methods. (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
Current edition approved March 15, 2024. Published March 2024. Originally www.aami.org.
4
approved in 2021. Last previous edition approved in 2021 as F3438 – 21. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F3438-24. 4th Floor, New York, NY 10036, http://www.ans
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3438 − 21 F3438 − 24
Standard Guide for
Detection and Quantification of Cleaning Markers (Analytes)
for the Validation of Cleaning Methods for Reusable Medical
1
Devices
This standard is issued under the fixed designation F3438; 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
1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical
device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the
instructions for use (IFU) provided by the medical device manufacturer.
1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test
soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example,
bone) will require other methods.
1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series
is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical
devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on
medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of
detecting and quantifying residual analytes on the device.
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this
standard.
1.5 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.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved March 1, 2021March 15, 2024. Published March 2021March 2024. Originally approved in 2021. Last previous edition approved in 2021 as
F3438 – 21. DOI: 10.1520/F3438-21.10.1520/F3438-24.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3438 − 24
D7573 Test Method for Total Carbon and Organic Carbon in Water by High Temperature Catalytic Combustion and Infrared
Detection
E1097 Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
E2520 Practice for Measuring and Scoring Performance of Trace Explosive Chemical Detectors
F3127 Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
F3208 Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
F3293 Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
F3321 Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
3
2.2 AAMI Documents:
AAMI TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for
medical device manufacturers
AAMI TIR30ST98 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable Cleaning
validation of health care products—Requirements for development and validation of a cleaning process for medical de
...