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Radiation Sterilization ISO § 757 Executive Series 82
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Links • • GHTF Quality Management Systems - Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/... • • ISO 13485:2016: https://www.iso.org/standard/59752.html • • Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download • o Chapter 3: Task 7 • o Chapter 6: Tasks 9 • • ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices: https://www.iso.org/standard/33952.html • • The Future of Gamma Irradiation for Medical Device Sterilization, Martin Comben, Nov 24, 2021: https://www.mddionline.com/sterilizat... • • Risks of Using Sterilization by Gamma Radiation: The Other Side of the Coin, by C. Randall Harrell, Valentin Djonov, Crissy Fellabaum, and Vladislav Volarevic, 18Jan2018: https://www.ncbi.nlm.nih.gov/pmc/arti... • Requirement name and location • Our topic, Radiation Sterilization, is covered by ISO 13485 § 7.5.7 • Radiation Sterilization in 5 words: • Ionizing Radiation Kills all Microorganisms
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