ASTM-F703 2002

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F703-96(2002)e1 Standard Specification for Implantable Breast Prostheses

Published By	Publication Date	Number of Pages
ASTM	2002	9

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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, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell 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 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

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	Materials and Manufacture
3	FIG. 1
4	Volume and Dimensions Significance and Use Fixation Sites Orientation Means Gel Bleed Biocompatibility
5	Valve Competence Sterilization Packaging, Labelling, and Package Inserts Keywords X1. RATIONALE X1.1 X1.2 X1.3
6	X1.4 X1.5 X1.6 X1.7 X1.8 X1.9 X1.10
7	X2. FEASABILITY PROTOCOL FOR GEL BLEED IN-VITRO TESTING BY MEANS OF A SILICONE DISK X2.1 Scope X2.2 Summary of Test Method X2.3 Apparatus X2.4 Test Specimen Configuration X2.5 Number of Test Specimens X2.6 Test Specimen Preparation X2.7 Procedure for Cleaning Test Containers X2.8 Procedure for Testing
8	X2.9 Recording of Data X2.10 Calculation X2.11 Test Limitations X2.12 Report
9	REFERENCES

Additional information

Standard Title	F703-96(2002)e1 Standard Specification for Implantable Breast Prostheses
Published Code	ASTM
Publication Date	2002
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F703 2002

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