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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
    Edition: 2021
    $86.11
    Unlimited Users per year

Description of ASTM-F1839 2021

ASTM F1839-08-Reapproved2021

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




ASTM F1839

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.


Keywords

bone; cellular plastic; medical devices; polyurethane; rigid foam;


ICS Code

ICS Number Code 11.040.01 (Medical equipment in general)


DOI: 10.1520/F1839-08R21

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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