| ASTM F1839-08 (Reapproved 2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 11-242 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
| FDA Tech | Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3040 | Fastener, Fixation, Nondegradable, Soft Tissue | Class 2 | MBI |
| §888.3040 | Screw, Fixation, Bone | Class 2 | HWC |
| §888.3040 | Screw, Fixation, Bone, Non-Spinal, Metallic | Class 2 | NDJ |
| §888.3030 | Fastener, Fixation, Biodegradable, Soft Tissue | Class 2 | MAI |
| There is no relevant guidance developed at this time. |