ASTM-F648 2010

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F648-10 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Published By	Publication Date	Number of Pages
ASTM	2010	9

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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 requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidents.

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) .

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.

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 TABLE 2
4	A1. IMPACT STRENGTH A1.1 General Description A1.2 Apparatus A1.3 Test Specimen A1.4 Notching of Specimens FIG. A1.1
5	A1.5 Conditioning A1.6 Procedure FIG. A1.2
6	A1.7 Report A1.8 Measurement Method of Imperfections in Specimen Notching A2. MORPHOLOGY EVALUATION A2.1 General Description A2.2 Test Specimens FIG. A1.3
7	A2.3 Preparing Thin Film Specimens A2.4 Definitions A2.5 Procedure A2.6 Report FIG. A2.1
8	X1. RATIONALE X1.1 X1.2 X1.3 X1.4 X1.5 X1.6 X1.7 X1.8 FIG. A2.2
9	REFERENCE

Additional information

Standard Title	F648-10 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Published Code	ASTM
Publication Date	2010
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics 83.080.20 - Thermoplastic materials

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ASTM-F648 2010

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