ASTM-F1839 › Historical Revision Information
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
The following bibliographic material is provided to assist you with your purchasing decision:
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.
Scope
1.1 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.
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in . 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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.
Keywords
bone; cellular plastic; medical devices; polyurethane; rigid foam; ICS Number Code 11.040.01 (Medical equipment in general)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.040.01 (Medical equipment in general)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ASTM-F1839-01(2007)
Revision Level
2001 R07 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
Oct. 1, 2007
Document Type
Specification
Page Count
6 pages
Committee Number
F04.21