1. Scope

1.1 This specification covers Ultra-High Molecular Weight Polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.

1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.

1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked.

1.4 The provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.

1.5 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4, 5, 6) .

1.6 The following precautionary caveat pertains only to the test method portion, Section 7, 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

D638 Test Method for Tensile Properties of Plastics

D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D1898 Practice for Sampling of Plastics

D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials

F619 Practice for Extraction of Medical Plastics

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F756 Practice for Assessment of Hemolytic Properties of Materials

F763 Practice for Short-Term Screening of Implant Materials

F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

ISO Standards

Keywords

fabricated forms; powdered form; ultra-high molecular weight polyethylene ;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)

DOI: 10.1520/F0648-04

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