ASTM-F755 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ASTM-F755 - 1999 R11 EDITION - CURRENT
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This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications. Physical properties such as pore size and volume, as well as tensile, compressive, flexural, and shear properties shall be determined, but will be specified in the particular device to which its end use shall be applied.

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Scope

1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications.

1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.

1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.

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

1.5 This section 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.

Keywords

plastic surgical devices/applications; polyethylene (PE) plastics/surgical implant applications; polymers-surgical applicant            ; Plastic surgical devices/applications--specifications; Polyethylene (PE) surgical implant applications--specifications; Polymers (surgical applications)--specifications; Surgical implants--specifications; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F755-99(2011)

Revision Level

1999 R11 EDITION

Status

Current

Modification Type

Reapproval

Publication Date

Jan. 31, 2012

Document Type

Specification

Page Count

3 pages

Committee Number

F04.11