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

ASTM-F1839 - 2008 R21 EDITION - CURRENT
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Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
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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.

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

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

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)

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Document Number

ASTM-F1839-08R21

Revision Level

2008 R21 EDITION

Status

Current

Modification Type

New

Publication Date

Feb. 10, 2021

Document Type

Specification

Page Count

6 pages

Committee Number

F04.21