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ASTM F 1839 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments


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ASTM F 1839 Document Information:

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

ASTM International

Publication Date:
Oct 10, 2001

Scope:

This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopedic 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.

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.

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.

This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.

This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.

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.

Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.

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 and health practices and determine the applicability of regulatory limitations prior to use.

Keywords:

bone
cellular plastic
medical devices
polyurethane
rigid foam

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