This Document establishes the requirements for material, marking, finishing, care and handling, dimensions, sterilization, manufacturing, packaging, and acceptable tolerances, as well as establishes the performance requirements for metallic bone screws used as implants for osteosynthesis. This Document does not apply to implantable screws intended for the reconstruction or fixation of soft tissues, including suture anchors and interference screws. This Document does not apply to implantable screws intended for spine applications. However, the principles of this Document can be applied to these screws at user’s discretion.
Registration number (WIID)
89938
Scope
This Document establishes the requirements for material, marking, finishing, care and handling, dimensions, sterilization, manufacturing, packaging, and acceptable tolerances, as well as establishes the performance requirements for metallic bone screws used as implants for osteosynthesis. This Document does not apply to implantable screws intended for the reconstruction or fixation of soft tissues, including suture anchors and interference screws. This Document does not apply to implantable screws intended for spine applications. However, the principles of this Document can be applied to these screws at user’s discretion.
