Denise A. Cleghorn - CIRMS

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What am I required to do Define your sterilization equipment (ISO 11137-1 Section 6) Define your product (ISO 11137-1 Section 7) Define your process (ISO 11137-1 Section 8) 1. Maximum Acceptable Dose (8.1) 2. Sterilization Dose (8.2) Validate your process (ISO 11137-1 Section 9) 1. Equipment Installation Qualification (9.1) 2. Equipment Operational Qualification (9.2) 3. Process / Performance Qualification (PQ) (9.3) Monitoring & Control of your process (ISO 11137-1 Section 10) 8
QUESTION What is a CRITICAL component to your radiation sterilization validation DOSIMETRY 9
Page 1 and 2: ACHIEVING MEASUREMENT TRACEABILITY
Page 3 and 4: What is the intended effect to be a
Page 5 and 6: What is the intended effect to be a
Page 7: What standards should I follow Indu
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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