ASTM-F703 2007

$40.63

F703-07 Standard Specification for Implantable Breast Prostheses

Published By	Publication Date	Number of Pages
ASTM	2007	10

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

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Description

1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.

1.2 Limitations This specification does not cover custom fabricated implantable breast prostheses.

1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F 2051.

1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Significance and Use Materials and Manufacture Volume and Dimensions
3	Fixation Sites Orientation Means Test Methods and Requirements
4	Other Test Methods FIG. 1
5	Sterilization Packaging, Labeling, and Package Inserts Keywords A1. GEL COHESION TEST METHOD A1.1 Apparatus A1.2 Preparation for Testing A1.3 Procedure for Testing
6	FIG. A1.1 FIG. A1.2
7	A2. FEASABILITY PROTOCOL FOR GEL BLEED IN-VITRO TESTING BY MEANS OF A SILICONE DISK A2.1 Scope A2.2 Summary of Test Method FIG. A1.3
8	A2.3 Apparatus A2.4 Test Specimen Configuration A2.5 Number of Test Specimens A2.6 Test Specimen Preparation A2.7 Procedure for Cleaning Test Containers A2.8 Procedure for Testing A2.9 Calculation A2.10 Test Limitations
9	A2.11 Report A3. GEL PENETRATION TEST METHOD A3.1 Apparatus A3.2 Preparation for Testing A3.3 Procedure for Testing A3.4 Precautions

Additional information

Standard Title	F703-07 Standard Specification for Implantable Breast Prostheses
Published Code	ASTM
Publication Date	2007
Pages Count	10
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F703 2007

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