ASTM F 703 : 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Specification for Implantable Breast Prostheses
Hardcopy , PDF
14-10-2022
English
06-03-2018
Important note : Users cannot be edited or removed once added to your Multi user PDF.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.
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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| Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023) |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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.