Name: ASTM F3487-20 - Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
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Abstract

Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device

SIGNIFICANCE AND USE
5.1 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device.
5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity.
5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity.
5.4 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 assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing.
1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part.
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 service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage.
1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part.
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 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-Oct-2020

ICS

11.040.01 - Medical equipment in general

Technical Committee

F04 - Medical and Surgical Materials and Devices

Drafting Committee

F04.15 - Material Test Methods

Current Stage

Ref Project

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ASTM F3487-20 - Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device

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ASTM F3487-20 - Standard Guide...

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: F3487 − 20
Standard Guide for
Assessing the Service Life of a Brush Part Intended to
1
Clean a Medical Device
This standard is issued under the ﬁxed designation F3487; 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 guide describes methods for assessing the service
Barriers to Trade (TBT) Committee.
life, under prescribed laboratory conditions, of a brush part
designed to clean a medical device. The method utilizes force
2. Referenced Documents
testers to mechanically actuate a brush part at a constant rate.
2
2.1 ASTM Standards:
This action continues until the brush part demonstrates a
F3275 Guide for Using a Force Tester to Evaluate Perfor-
signiﬁcant reduction in cleaning power as measured by the
mance of a Brush Part Designed to Clean the Internal
force exerted during testing.
Channel of a Medical Device
1.2 The test methods utilized in this guide are those de-
F3276 Guide for Using a Force Tester to Evaluate the
scribed in Guides F3275 and F3276. In this guide, the number
Performance of a Brush Part Designed to Clean the
of repetitions is open-ended and determined by the measurable
External Surface of a Medical Device
fatigue of the brush part as measured by a reduction in force,
as well as any observation of wear or damage to the brush part.
3. Terminology
1.3 Brushes designed to clean medical devices after clinical
3.1 Deﬁnitions:
useplayanimportantroleintheeffectivereprocessingofthose
3.1.1 brush set—working end of the brush that comes in
medical devices. Instructions for use from the brush manufac-
contact with the targeted surface of the substrate.
turershouldsupplyinformationrelatedtotheservicelifeofthe
4. Summary of Guide
brush. This may be stated in terms of (1) a time period; (2) the
number of uses; (3) inspection of the brush for wear and
4.1 This guide describes the application of test methods
damage.
described in Guides F3275 and F3276 to assess the service life
1.4 Inspection for wear should always be a part of the of a brush part intended to clean a medical device.
instructions for use of a brush. Application of this guide can
4.2 Through exhaustive repetitions of the applicable
help to determine like mode(s) of observable failure of a brush
method, the service life of the brush part can be estimated and
part.
described.
1.5 Units—The values stated in SI units are to be regarded
4.3 Determination of end-of-life:
as standard. No other units of measurement are included in this
4.3.1 The end-of-life for a brush part may be determined by
standard.
observable physical wear of the brush part. This may include
1.6 This standard does not purport to address all of the (see Fig. 1):
safety concerns, if any, associated with its use. It is the
4.3.1.1 Missing bristles,
responsibility of the user of this standard to establish appro- 4.3.1.2 Fallen bristles,
priate safety, health, and environmental practices and deter- 4.3.1.3 Twisted bristles,
mine the applicability of regulatory limitations prior to use. 4.3.1.4 Bent bristles,
1.7 This international standard was developed in accor- 4.3.1.5 Bentshaftofthebrush(typicallybrushesintendedto
dance with internationally recognized principles on standard- clean lumens),
ization established in the Decision on Principles for the 4.3.1.6 Damage to the block of the brush part (typically
brushes intended to clean surfaces), and
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 service@astm.org. For Annual Book of ASTM
Current edition approved Oct. 15, 2020. Published November 2020. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3487-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3487 − 20
FIG. 1 Observable Physical Wear of Brush Part
4.3.1.7 Untwistingofthewires(inthecaseofatwistedwire 6.2.1.2 For this guide, test soil is not required (Section 7.2
brush). of F3276).
4.3.2 Theend-of-lifemayalsobeindicatedbyareductionin
...

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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.
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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.
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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.
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SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.
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SIGNIFICANCE AND USE
5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure.
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SCOPE
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.
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1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.
1.5 Exclusion:
1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing
1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies.
1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.
1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact.
1.6...

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SIGNIFICANCE AND USE
5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.
Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required.
5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.
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SCOPE
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1....