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ASTM-F2051:2006 Edition

ASTM-F2051:2006 Edition

$40.63

F2051-00(2006) Standard Specification for Implantable Saline Filled Breast Prosthesis

Published By Publication Date Number of Pages
ASTM 2006 6
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1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.

1.2 Limitations

1.2.1 This specification does not cover custom fabricated implantable breast prostheses.

1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F 703.

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 Significance and Use
Materials
Volume and Dimensions
3 Fixation Sites
Orientation Means
Test Methods and Requirements
FIG. 1
4 Sterilization
Packaging, Labelling, and Package Inserts
Keywords
A1. TEST METHODS FOR ABRASION TESTING
A1.1 Abrasion Test—Wet Method
5 A1.2 Abrasion Test—Dry Method
6 X1. RATIONALE
X1.1
X1.2
X1.3
X1.4

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