scope:

Specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intraocular lenses. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacture , sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.