ASTM F3275-22
(Guide)Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
SIGNIFICANCE AND USE
5.1 This guide provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device.
5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured.
5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured.
5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs.
SCOPE
1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance.
1.2 Inclusions:
1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another.
1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.
1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes.
1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.
1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.
1.2.6 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.
1.3 Exclusions:
1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals) or other abrasive materials are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed.
1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested.
1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation.
1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).
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 an...
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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: F3275 − 22
Standard Guide for
Using a Force Tester to Evaluate Performance of a Brush
Part Designed to Clean the Internal Channel of a Medical
1
Device
This standard is issued under the fixed designation F3275; 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 evaluate modifications to designs and construction that might
improve performance.
1.1 Brushes used to clean a medical device after clinical use
1.2.6 This information can also be shared with the users of
play an important role in effective reprocessing. This guide
the brushes (medical device reprocessors) to help them evalu-
describes methods for characterizing, under prescribed labora-
ate the performance of commercially available brushes.
tory conditions, the efficacy of brush parts designed to clean
the internal channels of medical devices. The methods utilize a 1.3 Exclusions:
force tester to mechanically actuate a brush part within a 1.3.1 This guide does not assess potential damage that may
channel: (1) Methods to measure, at an established speed, the be inflicted by the brush. For instance, brushes with rigid
force required to move a brush within a channel; (2) Methods bristles (for example, stainless steel or other metals) or other
utilize the same force tester and protocols to measure soil abrasive materials are more likely to damage medical devices
removal from a soiled tube, another indicator of performance. thanbrusheswithflexiblebristles(forexample,nylon)ormore
pliable materials. Potential damage from more abrasive mate-
1.2 Inclusions:
rials should be assessed.
1.2.1 This guide describes objective, quantifiable, and re-
1.3.2 This guide does not specify acceptance criteria, and
producible methods for evaluating the cleaning characteristics
the results will be dependent on the specific parameters (for
ofabrushpartunderprescribedlaboratoryconditions,withtest
example, test soil, drying time, channel inside diameter and
methodsthatsimulatethecleaningchallengeofadefinedtarget
material, and so forth) that are tested.
area(s) of a medical device. This also makes possible the
1.3.3 This guide is not intended to constitute all steps
comparison of one design of a brush part to another.
required to conduct validation of cleaning instructions for a
1.2.2 In this guide, a brush part is one that is intended to be
medical device, including the use of brushes for this purpose,
moved within a tube.
but provides methods that may be part of a broader protocol to
1.2.3 Tubes used for testing described in this guide are
conduct a complete cleaning instructions validation.
cylindrical and uniform in diameter. The test methods describe
1.3.4 If a brush is intended to clean a specific device(s),
may not apply to non-cylindrical tubes.
cleaning validation shall include testing with that device(s).
1.2.4 By use of this guide, medical device manufacturers
can characterize the brush part designed for cleaning their 1.4 Units—The values stated in SI units are to be regarded
device. as standard. No other units of measurement are included in this
1.2.5 By use of this guide, manufacturers of cleaning standard.
brushes can evaluate and characterize the cleaning perfor-
1.5 This standard does not purport to address all of the
mance of their brushes for the target area(s) of medical
safety concerns, if any, associated with its use. It is the
device(s), including allowing a comparison with existing brush
responsibility of the user of this standard to establish appro-
part designs offered on the market. Further, they are able to
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.6 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 F3275 – 19. DOI:
10.1520/F3275-22. Barriers to Trade (TBT) Committee.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West
...
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: F3275 − 19 F3275 − 22
Standard Guide for
Using a Force Tester to Evaluate Performance of a Brush
Part Designed to Clean the Internal Channel of a Medical
1
Device
This standard is issued under the fixed designation F3275; 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 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes
methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal
channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods
to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester
and protocols to measure soil removal from a soiled tube, another indicator of performance.
1.2 Inclusions:
1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush
part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of
a medical device. This also makes possible the comparison of one design of a brush part to another.
1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.
1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not
apply to non-cylindrical tubes.
1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.
1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their
brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on
the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.
1.2.6 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.
1.3 Exclusions:
1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for
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 Jan. 15, 2019Jan. 1, 2022. Published February 2019January 2022. Originally approved in 2019. Last previous edition approved in 2019 as
F3275 – 19. DOI: 10.1520/F3275-19.10.1520/F3275-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3275 − 22
example, stainless steel or other metals),metals) or other abrasive materials,materials are more likely to damage medical devices
than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials
should be assessed.
1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example,
test soil, drying time, channel inside diameter and material, and so forth) that are tested.
1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device,
including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete
cleaning instructions validation.
1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).
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
...
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