Denise A. Cleghorn - CIRMS

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What standards should I follow Industry Standard for Food: ISO 14470 “Food Irradiation- Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food” Twelve ASTM E10.01/E61 standards are referenced in ISO 14470: 2011 6
What standards should I follow Industry Standard for Health Care Products: ISO 11137-1:2006 “Sterilization of Healthcare Products – Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices” ISO 11137-2:2012 “Sterilization of Healthcare Products – Radiation – Part 2: Establishing the sterilization dose” ISO 11137-3:2006 “Sterilization of Healthcare Products – Radiation – Part 3: Guidance on dosimetric aspects” 1 1 Fourteen ASTM E10.01/E61 standards are referenced in ISO 11137-3:2006 7
Page 1 and 2: ACHIEVING MEASUREMENT TRACEABILITY
Page 3 and 4: What is the intended effect to be a
Page 5: What is the intended effect to be a
Page 9 and 10: QUESTION What is a CRITICAL compone
Page 11 and 12: Dose Measurement How can I ensure t
Page 13 and 14: Unbroken Calibration Chain For trac
Page 15 and 16: Traceability Chain Standards Labora
Page 17 and 18: Traceability can be lost by: Calibr
Page 19 and 20: E2303 Dose Mapping Prerequisite 5.2
Page 21 and 22: Define your process Maximum Dose Wh
Page 23 and 24: What am I required to do Validate y
Page 25 and 26: What am I required to do Monitoring
Page 27: Subcommittee E61.01 Dosimetry ASTM

Denise A. Cleghorn - CIRMS

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