ASTM-F1634:2000 Edition

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F1634-95(2000) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

Published By	Publication Date	Number of Pages
ASTM	2000	5

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

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Description

ASTM F1634-95-Reapproved2000

Historical Standard: Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

ASTM F1634

Scope

1.1 This practice covers two procedures for conditioning non-absorbable polymer matrix composite (PMC) materials and implant devices in a liquid environment to obtain a state of saturation.

1.2 The purpose of this practice is to standardize methods and reporting procedures for conditioning PMC materials and implant devices (PMC specimens) in a user selected liquid environment prior to conducting subsequent tests. It is not the purpose of this practice to determine the diffusion coefficients or actual saturation levels of a given liquid into the materials and devices. For these determinations, other procedures, such as Test Method D 5229, may be followed.

1.3 Diffusion of liquid into a solid material is a slow process. While the time necessary to achieve saturation at 37°C may be sufficiently short for thin specimens, such as fracture fixation plates, it may be prohibitively long in thick sections, such as femoral components for hip arthroplasty. However, the diffusion process may be accelerated at an elevated temperature. Consequently, two separate procedures (Procedures A and B) are presented in this practice. Procedure A covers exposing the specimen to the desired conditioning environment at 37°C. Procedure B prescribes a method to accelerate the diffusion process by conditioning the specimen at a selected elevated temperature.

1.4 This practice does not specify the test environment to be used for conditioning. However, the pH value of immersion liquid shall be maintained at 7.4 ± 0.2 to simulate the in vivo environment.

1.5 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.

Keywords

accelerated conditioning; composite; diffusion; environmental conditioning; fiber; implant devices; moisture absorption; polymer

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1634-95R00

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Summary of Test Method Significance and Use Apparatus Sampling and Test Specimens Measurements of Test Specimens Visual Examination Procedures
3	Selection of Conditioning Procedure Report
4	Keywords X1. RATIONALE X1.1 X1.2 X1.3 X1.4 X1.5 X1.6 X1.7 X1.8

Additional information

Standard Title	F1634-95(2000) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
Published Code	ASTM
Publication Date	2000
Pages Count	5
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics