ASTM F3276-22
(Guide)Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
SIGNIFICANCE AND USE
5.1 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers.
5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness.
5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface.
5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs
SCOPE
1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance.
1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices.
1.3 Inclusions:
1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another.
1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance.
1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.
1.4 Exclusions:
1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion.
1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigid-bristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide.
1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested.
1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted.
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated...
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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: F3276 − 22
Standard Guide for
Using a Force Tester to Evaluate the Performance of a
Brush Part Designed to Clean the External Surface of a
1
Medical Device
This standard is issued under the fixed designation F3276; 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 1.4 Exclusions:
1.4.1 This guide is not intended to be used for brushes
1.1 This guide describes methods for characterizing the
designed to clean medical devices using rotational motion.
efficacy,underprescribedlaboratoryconditions,ofabrushpart
1.4.2 This guide does not assess potential damage that may
designed to clean the external surface of a medical device. The
be inflicted by the brush, or degradation of the brush that may
method utilizes force testers to mechanically actuate a brush
occur during repeated use. Brushes with rigid bristles (for
part across a surface at a constant rate and constant pressure. In
example, stainless steel or other metals) are predicted to be
thefirstmethod,theforcerequiredtoactuateacrossthesurface
more likely to damage medical devices than brushes with
is measured. In the next method, which utilizes the same force
flexible bristles (for example, nylon); damage from rigid-
testers and protocol (actuation motion), the brush part is
bristled brushes should be assessed. Assessing repeated use
actuated on a soiled surface and the amount of soil removed is
would require a greatly increased number of test repetitions
measured, as another indicator of performance.
than what is described in this guide.
1.2 Brushes designed to clean medical devices after clinical
1.4.3 This guide does not specify acceptance criteria, and
useplayanimportantroleintheeffectivereprocessingofthose
theresultswillbedependentonthespecificparametersthatare
medical devices.
tested (for example, test soil, drying time, surface area, and
materials, etc.) that are tested.
1.3 Inclusions:
1.3.1 This guide describes objective, quantifiable, and re- 1.4.4 This guide is not intended to constitute all steps
required to conduct validation of cleaning instructions for a
producible methods for evaluating the cleaning characteristics
medical device, including use of brushes for this purpose, but
of a brush part, under prescribed laboratory conditions, with a
test method that simulates the cleaning challenge of a defined provides methods that may be part of a broader protocol to
conduct a complete cleaning instructions validation. Separate
target area(s) of a medical device. This also makes it possible
to compare one brush part design to another. medical device cleaning instruction validation studies must be
conducted.
1.3.2 By use of this guide, manufacturers of cleaning
brushes will be able to evaluate and characterize the cleaning
1.5 Units—The values stated in SI units are to be regarded
performance of their brushes for the target area(s) of medical
as standard. No other units of measurement are included in this
device(s)andevaluatemodificationstodesignandconstruction
standard.
that might improve performance.
1.6 This standard does not purport to address all of the
1.3.3 By use of this guide, this information can also be
safety concerns, if any, associated with its use. It is the
shared with the users of the brushes (medical device reproces-
responsibility of the user of this standard to establish appro-
sors) to help them evaluate the performance of commercially
priate safety, health, and environmental practices and deter-
available brushes.
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
1
dance with internationally recognized principles on standard-
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
ization established in the Decision on Principles for the
F04.15 on Material Test Methods.
Development of International Standards, Guides and Recom-
Current edition approved Jan. 1, 2022. Published January 2022. Originally
mendations issued by the World Trade Organization Technical
approved in 2019. Last previous edition approved in 2019 as F3276 – 19. DOI:
10.1520/F3276-22. Barriers to Trade (TBT) Committee.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3276 − 22
2. Referenced Documents
...
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: F3276 − 19 F3276 − 22
Standard Guide for
Using a Force Tester to Evaluate the Performance of a
Brush Part Designed to Clean the External Surface of a
1
Medical Device
This standard is issued under the fixed designation F3276; 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 guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed
to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a
surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured.
In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled
surface and the amount of soil removed is measured, as another indicator of performance.
1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those
medical devices.
1.3 Inclusions:
1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush
part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s)
of a medical device. This also makes it possible to compare one brush part design to another.
1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance
of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve
performance.
1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help
them evaluate the performance of commercially available brushes.
1.4 Exclusions:
1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion.
1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur
during repeated use. Brushes with rigid bristles (e.g., (for example, stainless steel or other metals) are predicted to be more likely
1
This test method 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 Feb. 15, 2019Jan. 1, 2022. Published March 2019January 2022. Originally approved in 2019. Last previous edition approved in 2019 as
F3276 – 19. DOI: 10.1520/F3276-19.10.1520/F3276-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3276 − 22
to damage medical devices than brushes with flexible bristles (e.g., (for example, nylon); damage from rigid-bristled brushes
should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in
this guide.
1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested
(e.g., (for example, test soil, drying time, surface area, and materials, etc.) that are tested.
1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device,
including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete
cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted.
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this
standard.
1.6 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.
1.7 This international standard was developed in accordance with internationally recognized principles on stan
...
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