1.1This 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.
1.2Limitations:
1.2.1This specification does not cover custom fabricated implantable breast prostheses.
1.2.2This specification does not cover gel/saline type implants, which are within the scope of Specification F703.
1.3This 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.
1.4This 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.
