ASTM F703-26

Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ASTM F703-26 :

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.

Keywords:

breast prosthesis, gel-saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, silicone gel prosthesis, soft tissue implant,, ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics)