Name: ASTM F1839-08(2021) - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instrumen
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Abstract

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
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.
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.
1.5 This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots.
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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.
1.9 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

31-Jan-2021

ICS

11.040.01 - Medical equipment in general

Technical Committee

F04 - Medical and Surgical Materials and Devices

Drafting Committee

F04.21 - Osteosynthesis

Current Stage

Ref Project

Relations

Refers

ASTM D1622-20 - Standard Test Method for Apparent Density of Rigid Cellular Plastics

Effective Date

15-Jul-2020

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ASTM F1839-08(2021) - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

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ASTM F1839-08(2021) - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

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ASTM F1839-08(2021) - Standard...

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:F1839 −08 (Reapproved 2021)
Standard Speciﬁcation for
Rigid Polyurethane Foam for Use as a Standard Material for
1
Testing Orthopaedic Devices and Instruments
This standard is issued under the ﬁxed designation F1839; 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 environmental practices and determine the applicability of
regulatory limitations prior to use.
1.1 This speciﬁcation covers rigid unicellular polyurethane
1.9 This international standard was developed in accor-
foam for use as a standard material for performing mechanical
dance with internationally recognized principles on standard-
tests utilizing orthopaedic devices or instruments. The speciﬁ-
ization established in the Decision on Principles for the
cation is applicable to sheets or blocks of foam, or foam that is
Development of International Standards, Guides and Recom-
made by the user using a two-part liquid mixture.
mendations issued by the World Trade Organization Technical
1.2 This speciﬁcation covers polyurethane foam material
Barriers to Trade (TBT) Committee.
that is used in the laboratory for mechanical testing, as
described in 1.1. These materials are not intended for implan-
2. Referenced Documents
tation into the human body.
2
2.1 ASTM Standards:
1.3 The foam described herein possesses mechanical prop-
C273 Test Method for Shear Properties of Sandwich Core
erties which are on the order of those reported for human
Materials
cancellous bone. See Appendix X1, Rationale, for further
D1621 Test Method for Compressive Properties of Rigid
information regarding the appropriateness of using the speci-
Cellular Plastics
ﬁed foam as a model for human cancellous bone.
D1622 Test Method for Apparent Density of Rigid Cellular
Plastics
1.4 This speciﬁcation covers compositional requirements,
E4 Practices for Force Veriﬁcation of Testing Machines
physical requirements, mechanical requirements, and test
F543 Speciﬁcation and Test Methods for Metallic Medical
methods for rigid polyurethane foam in the solid ﬁnal form.
Bone Screws
1.5 This speciﬁcation provides qualiﬁcation criteria for
vendor or end user processes and acceptance criteria for
3. Terminology
individual material lots.
3.1 Deﬁnitions:
1.6 Thisspeciﬁcationprovidesmechanicalpropertiesofﬁve
3.1.1 ﬁnal form—the condition of the foam product when
different grades of foam in the solid ﬁnal form. A foam that
used by the end user to perform tests of orthopaedic devices or
does not meet the speciﬁed mechanical properties shall be
instruments.
identiﬁed as an ungraded foam.
3.1.1.1 Discussion—This is the condition of the foam prod-
1.7 The values stated in SI units are to be regarded as uct of which all physical and mechanical tests required by this
standard. No other units of measurement are included in this speciﬁcation are performed. In the ﬁnal form the foam is in a
standard. uniform solid such as a slab, plate, or block.
1.8 The following precautionary statement pertains to the 3.1.2 foam rise direction—the nominal direction that the
test method portion only, Section 8, of this speciﬁcation: This foam rises during the polymerization (“foaming”) process,
standard does not purport to address all of the safety concerns, either at the supplier’s production facilities for the solid
if any, associated with its use. It is the responsibility of the user supplied foam, or at the end user’s facilities for foam produced
of this standard to establish appropriate safety, health, and from the liquid supplied form. The foam rise direction shall be
marked on the foam block or indicated in the shipping
documentation for foam that is supplied in the solid form.
1
This speciﬁcation is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2021. Published February 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2016 as F1839 – 08 (2016). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F1839-08R21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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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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SCOPE
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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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1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.
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.
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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.
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5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.
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SCOPE
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