ASTM F1839-08 (2021) PDF

Full title and description

ASTM F1839-08(2021) — Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. This specification defines compositional, physical and mechanical requirements and test methods for rigid unicellular polyurethane foam supplied as blocks or sheets (or prepared from a two‑part liquid) for laboratory mechanical testing of orthopedic devices (for example, screw pullout and fixation tests). The foam is intended as a consistent test medium with properties on the order of human cancellous bone but is not intended for implantation.

Abstract

This specification covers rigid polyurethane foam used as a standardized artificial bone substitute for mechanical testing of orthopedic devices and instruments. It specifies appearance and dimensional quality, void content limits, compressive strength and modulus, shear strength and modulus, screw pullout performance, specimen conditioning and acceptance criteria for five graded foam densities. The standard provides vendor and user qualification criteria to promote reproducibility and comparability of device test results.

General information

• Status: Active / current edition (revised 2021).
• Publication date: January 2, 2021 (designation F1839-08(2021); original designation F1839-08 published 2008; reapprovals/revisions issued in subsequent years).
• Publisher: ASTM International.
• ICS / categories: 11.040.01 (Medical equipment in general); materials testing; orthopedic devices.
• Edition / version: F1839-08 with 2021 revision (commonly cited as ASTM F1839-08(2021)).
• Number of pages: 6 pages (concise specification).

Scope

The standard applies to rigid unicellular polyurethane foam intended as a laboratory test medium for mechanical evaluation of orthopedic devices and instruments. It covers foam supplied as blocks or sheets or produced by a two‑part liquid mixture, and sets out compositional, dimensional, physical and mechanical property requirements and test methods. It explicitly notes that the foam is not a substitute for living bone and is not intended for implantation; its purpose is to provide a reproducible material with properties on the order of cancellous bone for comparative mechanical testing (e.g., screw pullout, compression, shear).

Key topics and requirements

• Definition of five graded foam densities and associated target mechanical properties (compressive strength, compressive modulus, shear strength, shear modulus).
• Appearance and dimensional stability requirements and tolerances for test specimens or supplied blocks/sheets.
• Limits for void content and acceptable defect/void sizes to ensure test consistency.
• Specified test methods for compressive and shear properties and for screw pullout performance (including specimen preparation and conditioning requirements).
• Acceptance criteria for lot qualification and for end‑user verification of supplier material.
• Requirement to use SI units as the standard; inch‑pound conversions may be informational only.
• Vendor and user responsibilities for storage, handling and lot traceability to avoid duplicated or inconsistent testing.

Typical use and users

ASTM F1839 is used by orthopedic implant and instrument manufacturers, independent mechanical testing laboratories, research and development teams, regulatory and verification groups, and suppliers of artificial bone materials. Typical uses include comparative screw pullout testing, insertion/pullout validation of fixation devices, bench mechanical testing during product development, and quality control of test media used in orthopedic device testing programs.

Related standards

Commonly referenced and complementary standards include ASTM D1621 (Standard Test Method for Compressive Properties of Rigid Cellular Plastics) for compression testing of cellular materials, ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws) for screw test methods and dimensions used in pullout evaluations, and other ASTM test methods and practices that govern specimen conditioning and mechanical testing of plastics and cellular materials. Users should consult the normative references listed in the specification for full cross‑references.

Keywords

rigid polyurethane foam; artificial bone; cancellous bone substitute; orthopedic testing; screw pullout; compressive strength; shear modulus; test blocks; ASTM F1839; test specimen conditioning; material acceptance criteria.

FAQ

Q: What is this standard?

A: ASTM F1839-08(2021) is a short specification that defines the physical and mechanical requirements and test methods for rigid unicellular polyurethane foam used as a reproducible laboratory test medium for mechanical testing of orthopedic devices and instruments.

Q: What does it cover?

A: It covers supplied foam blocks/sheets or foam made from a two‑part mixture, specifying appearance, dimensional stability, void content limits, compressive and shear properties, screw pullout behavior, specimen preparation and conditioning, and acceptance/qualification criteria for multiple graded foam densities. It clarifies that the material is not for implantation.

Q: Who typically uses it?

A: Orthopedic device manufacturers, test and calibration laboratories, research teams, suppliers of artificial bone materials, and regulatory/quality groups that require standardized test media for comparative mechanical testing.

Q: Is it current or superseded?

A: The version designated ASTM F1839-08(2021) is the current published revision as of January 2, 2021. Users should verify the status before use; periodic 5‑year reviews and work items for revision may be open, so check with ASTM or an official standards provider for the absolute latest status and any pending revisions.

Q: Is it part of a series?

A: It is a single specification within ASTM Committee F04 (Medical and Surgical Materials and Devices) and is commonly used alongside related ASTM test methods and device standards (for example, compressive property and screw test standards) to create a complete test program for orthopedic devices.

Q: What are the key keywords?

A: Keywords include rigid polyurethane foam, artificial bone, cancellous bone substitute, screw pullout, compressive strength, shear modulus, orthopedic testing, ASTM F1839.