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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 11-242
Standard
ASTM  F1839-08 (Reapproved 2016)
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3030 Fastener, Fixation, Biodegradable, Soft Tissue Class 2 MAI
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3040 Fastener, Fixation, Nondegradable, Soft Tissue Class 2 MBI
§888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic Class 2 NDJ
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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