ASTM F3602-22

Standard Guide for Assessing the Compatibility of a Cleaning Brush Part with Different Substrates Used in the Construction of Medical Devices

SIGNIFICANCE AND USE
5.1 This guide describes the use of test methods in Guide F3276 to assess the compatibility of a brush part with the material substrates used in the construction of medical devices.  
5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this standard can improve the ability to assess the effectiveness of various brush part designs.
SCOPE
1.1 This guide describes methods for assessing the compatibility, under prescribed laboratory conditions, of a cleaning brush part with substrate materials used in the construction of medical devices. The method utilizes a force tester to mechanically actuate a brush part at a constant rate. This action continues until there is demonstrable degradation, if any, of the substrate material.  
1.2 The test methods utilized in this guide are those described in Guide F3276. In this guide, the number of repetitions is determined by the demonstrable degradation, if any, of the substrate, up to a specified maximum number of repetitions.  
1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the compatibility, or more importantly, incompatibility with materials that make up the composition of a medical device. This may be stated in terms of being suitable for specific materials, not suitable for specific materials, or suitable for a limited number of uses for specific materials.  
1.4 Selecting the correct brush for the medical device to be cleaned is always a key factor to achieve effective cleaning. One of the significant factors when selecting a brush is selecting one that will not cause damage to the medical device, including the material the medical device is constructed of. Assessing if a brush part could damage a medical device because of the material the device is made of is an important step in determining the appropriate (and inappropriate) use of a brush.  
1.5 Units—The values stated in SI units are to be regarded as the 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 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: Historical
• Publication Date: 31-Aug-2022
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Standards Content (Sample)

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: F3602 − 22
Standard Guide for
Assessing the Compatibility of a Cleaning Brush Part with
Different Substrates Used in the Construction of Medical
1
Devices
This standard is issued under the fixed designation F3602; 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 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide describes methods for assessing the
responsibility of the user of this standard to establish appro-
compatibility, under prescribed laboratory conditions, of a
priate safety, health, and environmental practices and deter-
cleaning brush part with substrate materials used in the
mine the applicability of regulatory limitations prior to use.
construction of medical devices. The method utilizes a force
1.7 This international standard was developed in accor-
tester to mechanically actuate a brush part at a constant rate.
dance with internationally recognized principles on standard-
This action continues until there is demonstrable degradation,
ization established in the Decision on Principles for the
if any, of the substrate material.
Development of International Standards, Guides and Recom-
1.2 The test methods utilized in this guide are those de-
mendations issued by the World Trade Organization Technical
scribed in Guide F3276. In this guide, the number of repetitions
Barriers to Trade (TBT) Committee.
is determined by the demonstrable degradation, if any, of the
substrate, up to a specified maximum number of repetitions.
2. Referenced Documents
1.3 Brushes designed to clean medical devices after clinical
2
2.1 ASTM Standards:
use play an important role in the effective reprocessing of those
F3276 Guide for Using a Force Tester to Evaluate the
medical devices. Instructions for use from the brush manufac-
Performance of a Brush Part Designed to Clean the
turer should supply information related to the compatibility, or
External Surface of a Medical Device
more importantly, incompatibility with materials that make up
the composition of a medical device. This may be stated in
3. Terminology
terms of being suitable for specific materials, not suitable for
3.1 Definitions:
specific materials, or suitable for a limited number of uses for
specific materials. 3.1.1 brush part—working end of the brush that comes in
contact with the targeted surface of the substrate.
1.4 Selecting the correct brush for the medical device to be
cleaned is always a key factor to achieve effective cleaning.
4. Summary of Guide
One of the significant factors when selecting a brush is
selecting one that will not cause damage to the medical device,
4.1 This guide describes the application of test methods
including the material the medical device is constructed of.
described in Guide F3276 to assess the compatibility of a brush
Assessing if a brush part could damage a medical device
part with the material substrate used in the construction of
because of the material the device is made of is an important
medical devices.
step in determining the appropriate (and inappropriate) use of
4.2 Through exhaustive repetitions of the applicable
a brush.
method, the compatibility of the brush part can be assessed and
1.5 Units—The values stated in SI units are to be regarded
described.
as the standard. No other units of measurement are included in
4.3 The maximum number of repetitions may be specified
this standard.
and shall be justified.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
2
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.15 on Material Test Methods. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved Sept. 1, 2022. Published September 2022. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3602-22. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3602 − 22
5. Significance and Use 7.1.1.2 Observe record the peak and average force.
7.1.1.3 Note any observable change in the substrate material
5.1 This guide describes the use of test methods in Guide
or the brush part.
F3276 to assess the compatibility of a brush part with the
7.1.1.4 If no observable wear or damage, then repeat step
material substrates used in the construction of medical devices.
7.1.1.1.
5.2
...