ASTM F3438-21
(Guide)Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
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.
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.
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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 −21
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This standard guide provides methods and consider-
ations for detecting and quantifying test soil(s) from reusable
2. Referenced Documents
medical device(s) that result from simulated-use testing of
2
medicaldevicesduringvalidationofthecleaningproceduresas 2.1 ASTM Standards:
described in the instructions for use (IFU) provided by the D7573TestMethodforTotalCarbonandOrganicCarbonin
medical device manufacturer. Water by High Temperature Catalytic Combustion and
Infrared Detection
1.2 The methods described are for detecting and measuring
E1097Guide for Determination of Various Elements by
markers (analytes) that are components within the most com-
Direct Current Plasma Atomic Emission Spectrometry
montestsoilsandarerelevanttotheclinicaluseofthedevice.
E2520Practice for Measuring and Scoring Performance of
Appropriatetestsoilswithoutprotein,carbon,orcarbohydrates
Trace Explosive Chemical Detectors
(for example, bone) will require other methods.
F3127GuideforValidatingCleaningProcessesUsedDuring
1.3 This is a part of a series of ASTM standard guides for
the Manufacture of Medical Devices
validating cleaning instructions.The scope of the first guide in
F3208Guide for Selecting Test Soils for Validation of
theseriesisselectingappropriatetestsoils(GuideF3208).The
Cleaning Methods for Reusable Medical Devices
second in the series (Guide F3293) describes methods for
F3293Guide forApplication ofTest Soils for theValidation
inoculating medical devices with test soil. The third in the
of Cleaning Methods for Reusable Medical Devices
series(GuideF3321)describesmethodsforextractingsoilsfor
F3321Guide for Methods of Extraction ofTest Soils for the
measuring residual soil on medical devices after the perfor-
Validation of Cleaning Methods for Reusable Medical
manceofcleaningprocess.Thisisthefourthguideintheseries
Devices
and describes the methods of detecting and quantifying re-
3
2.2 AAMI Documents:
sidual analytes on the device.
AAMI TIR12Designing, 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:
asstandard.Nootherunitsofmeasurementareincludedinthis
A guide for medical device manufacturers
standard.
AAMI TIR30A compendium of processes, materials, test
1.5 This standard does not purport to address all of the methods, and acceptance criteria for cleaning reusable
safety concerns, if any, associated with its use. It is the medical devices
4
responsibility of the user of this standard to establish appro-
2.3 ISO Standard:
priate safety, health, and environmental practices and deter-
ISO/TS 15883-5Washer-disinfectors—Part 5:Test soils and
mine the applicability of regulatory limitations prior to use.
methods for demonstrating cleaning efficacy
1.6 This international standard was developed in accor-
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
Development of International Standards, Guides and Recom-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This guide is under the jurisdiction ofASTM Committee F04 on Medical and Available from Association for the Advancement of Medical Instrumentation
Surgical Materials and Devices and is the direct responsibility of Subcommittee (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
F04.15 on Material Test Methods. www.aami.org.
4
Current edition approved March 1, 2021. Published March 2021. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3438-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3438−21
5
2.4 FDA Guidance Document: 6.1.2 Th
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3438 − 21
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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This standard guide provides methods and consider-
ations for detecting and quantifying test soil(s) from reusable
2. Referenced Documents
medical device(s) that result from simulated-use testing of
2
medical devices during validation of the cleaning procedures as 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
Infrared Detection
1.2 The methods described are for detecting and measuring
E1097 Guide for Determination of Various Elements by
markers (analytes) that are components within the most com-
Direct Current Plasma Atomic Emission Spectrometry
mon test soils and are relevant to the clinical use of the device.
E2520 Practice for Measuring and Scoring Performance of
Appropriate test soils without protein, carbon, or carbohydrates
Trace Explosive Chemical Detectors
(for example, bone) will require other methods.
F3127 Guide for Validating Cleaning Processes Used During
1.3 This is a part of a series of ASTM standard guides for
the Manufacture of Medical Devices
validating cleaning instructions. The scope of the first guide in
F3208 Guide for Selecting Test Soils for Validation of
the series is selecting appropriate test soils (Guide F3208). The
Cleaning Methods for Reusable Medical Devices
second in the series (Guide F3293) describes methods for
F3293 Guide for Application of Test Soils for the Validation
inoculating medical devices with test soil. The third in the
of Cleaning Methods for Reusable Medical Devices
series (Guide F3321) describes methods for extracting soils for
F3321 Guide for Methods of Extraction of Test Soils for the
measuring residual soil on medical devices after the perfor-
Validation of Cleaning Methods for Reusable Medical
mance of cleaning process. This is the fourth guide in the series
Devices
and describes the methods of detecting and quantifying re-
3
2.2 AAMI Documents:
sidual analytes on the device.
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 TIR30 A compendium of processes, materials, test
1.5 This standard does not purport to address all of the methods, and acceptance criteria for cleaning reusable
safety concerns, if any, associated with its use. It is the 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/TS 15883-5 Washer-disinfectors—Part 5: Test soils and
mine the applicability of regulatory limitations prior to use.
methods for demonstrating cleaning efficacy
1.6 This international standard was developed in accor-
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
Development of International Standards, Guides and Recom-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Available from Association for the Advancement of Medical Instrumentation
Surgical Materials and Devices and is the direct responsibility of Subcommittee (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
F04.15 on Material Test Methods. www.aami.org.
4
Current edition approved March 1, 2021. Published March 2021. DOI: 10.1520/ Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
F3438-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3438 − 21
5
2.4 FDA Guidance Document: 6.1.2 The limit of detection depends on the assay or reage
...
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