1. ISO 11137:1994, “Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization.”
2. ISO TR 13409-1996, “Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches.”
3. ISO Draft TR, “Sterilization of health care products — Radiation sterilization — Selection of a sterilization dose for a single production batch.”
4. ISO Draft TR, “Sterilization of health care products — Radiation sterilization — Product Families, Plans for Sampling and Frequency of Dose Audits.”
5. AAMI Draft TIR, “Radiation Sterilization Material Qualification,” 3330 Washington Blvd, Arlington, VA, 22201-4598, USA.