Standard Specification for Implantable Saline Filled Breast Prosthesis
|Publication Date:||10 July 2000|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.
This specification does not cover custom fabricated implantable breast prostheses.
This specification does not cover gel/saline type implants, which are within the scope of Specification F703.
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.