ASTM F703-07

Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)

Automatically translated name:

Standard Specification for Implantable Breast Prostheses

STANDARD published on 1.4.2007

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The information about the standard:

Designation standards: ASTM F703-07
Note: WITHDRAWN
Publication date standards: 1.4.2007
SKU: NS-56172
The number of pages: 10
Approximate weight : 30 g (0.07 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F703-07 :

Keywords:

breast prosthesis, gel-saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, silicone gel prosthesis, soft tissue implant, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

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.

2. Referenced Documents

F2051-00(2022)	Standard Specification for Implantable Saline-Filled Breast Prostheses
D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D1349-14(2019)	Standard Practice for Rubber´Standard Conditions for Testing
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F2042-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II´Crosslinking and Fabrication
F2038-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I´Formulations and Uncured Materials
ISO/AAMI/ANSI 10993-1	Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

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