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ASTM F 703 : 2018

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Implantable Breast Prostheses
Available format(s)

Hardcopy , PDF

Superseded date

10-14-2022

Language(s)

English

Published date

03-06-2018

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2018 Defines 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.

1.1This 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.

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

1.3Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F2051.

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

1.5This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
F 04
DocumentType
Standard
Pages
10
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 1027 : 1986 : R2017 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM F 2051 : 2000 : R2014 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM D 1349 : 2014 : R2019 Standard Practice for Rubber—Standard Conditions for Testing
ASTM F 2042 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 2014 : REDLINE Standard Practice for Rubber—Standard Conditions for Testing
ASTM F 2042 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 1999 Standard Practice for Rubber-Standard Temperatures For Testing
ASTM D 1349 : 2009 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D 1349 : 2014 Standard Practice for Rubber—Standard Conditions for Testing
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
ASTM F 2051 : 2000 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 2007 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM F 2038 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
ASTM F 2042 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
ASTM F 2051 : 2000 : R2006 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials

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