This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.This 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. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed.

1.1 This 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.

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

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

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

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

1.6 This 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.