ASTM F 703 : 2018 : R2022
Current
The latest, up-to-date edition.
Standard Specification for Implantable Breast Prostheses
Hardcopy , PDF
English
11-10-2022
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
American Society for Testing and Materials
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| Status |
Current
|
| 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| Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023) |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 : R2022 | Standard Specification for Soft-Tissue Expander Devices |
| ASTM F 2051 : 2000 : R2014 | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| ASTM F 2051 : 2000 : R2022 | Standard Specification for Implantable Saline-Filled Breast Prostheses |
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