Definitions

Term Definitions


  • Sterile : Free from bacteria or other living organisms; totally clean.
  • Sterility Assurance Level : The probability of a single allograft being completely sterile after it has been subjected to sterilization processes. A 10-6 sterility level means there is a 1 in 1,000,000 chance that any bacteria has survived.
  • Terminal Sterility : Sterilized in final packaging and delivered to the OR with an SAL of 10 -6.
  • Aseptic : allografts are processed irradiation free, under strict aseptic conditions. These grafts are handled in a controlled environment in which the air supply, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. This method of processing relies on donor screening, laboratory testing and aseptic processing for the safety of the implant. No terminal sterilization (irradiation) is added post packaging. These grafts are generally referred to as non-irradiated and have a Sterility Assurance Level of 10 -3.
  • Gamma Irradiation : Terminally sterile grafts processed with between .92 – 2.3 Mrads of gamma irradiation.
  • Electron-Beam : Terminally sterile grafts processed without the use of gamma irradiation. These allografts are processed.