scope:

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.