ASTM-F648 2007

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F648-07e1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Published By	Publication Date	Number of Pages
ASTM	2007	8

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, 83.080.20 - Thermoplastic materials, ASTM

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Description

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

1.4 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) .

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

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Virgin UHMWPE Powder Requirements UHMWPE Fabricated Form Requirements Sampling Test Methods TABLE 1
3	Biocompatibility Keywords A1. IMPACT STRENGTH A1.1 General Description A1.2 Apparatus A1.3 Test Specimen TABLE 2
4	A1.4 Notching of Specimens A1.5 Conditioning A1.6 Procedure FIG. A1.1
5	A1.7 Report A1.8 Measurement Method of Imperfections in Specimen Notching FIG. A1.2
6	A2. MORPHOLOGY EVALUATION A2.1 General Description A2.2 Test Specimens A2.3 Preparing Thin Film Specimens A2.4 Definitions FIG. A1.3
7	A2.5 Procedure A2.6 Report X1. RATIONALE X1.1 X1.2 X1.3 X1.4 X1.5 X1.6 X1.7 FIG. A2.1 FIG. A2.2
8	X1.8 X1.9 REFERENCE

Additional information

Standard Title	F648-07e1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Published Code	ASTM
Publication Date	2007
Pages Count	8
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics 83.080.20 - Thermoplastic materials

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ASTM-F648 2007

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