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Regulatory

References

Regulatory authorities, academia and industry use these voluntary standards as reference and guidance documents. The standards continue to evolve as the latest technology advances and practices are incorporated. An example, the 2006 revised ISO 11137 Sterilization of Healthcare Products now includes guidance on modeling for radiation processing facilities.

ASTM 2232: Standard Practice for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Applications

ISO/ASTM 51607: Standard Practice for Use of the Alanine-EPR Dosimetry System

ISO/ASTM 51261: Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing

ISO/ASTM 51400: Standard Practice for Characterization and Performance of a High-Dose Radiation Dosimetry Calibration Laboratory

ISO/ASTM 51275: Standard Practice for Use of a Radiochromic Film Dosimetry System

ISO/ASTM 51649: Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 keV and 25 MeV

ANSI/AAMI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ANSI/AAMI/ISO 11137-3:2006, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

AAMI TIR 29: 2002 Guide for process control in radiation sterilization