Page 266 - Assurance of Sterility for Sensitive Combination Products and Materials

244 Assurance of sterility for sensitive combination products and materials

References
[1] John Capek, IMRP 2016 presentation, referencing WHO, McKinsey 2012-02-27 ABT
Newport Global Growth Presentation.
[2] J.W. Chou, M. Skornicki, J.T. Cohen, Unintended consequences of the potential
phase-out of gamma irradiation, F1000 Research 7 (2018) 348.
[3] Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) Center for
Disease Control and Prevention. https://www.cdc.gov/infectioncontrol/guidelines/
disinfection/sterilization/etheylene-oxide.html. Accessed: August 2, 2019.
[4] Food and Drug Administration (FDA), Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling. Accessed: August 2, 2019.
[5] ANSI/AAMI/ISO 13408-1:2008 (R2017)/A1:2013 “Aseptic Processing of Health
Care Products Package”.
[6] Food and Drug Administration (FDA), January 21, 2016, Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions for Devices La-
beled as Sterile: Guidance for Industry and Food and Drug Administration Staff.
[7] International Organization for Standards, ISO/TS 19930:2017 “Guidance on aspects
of a risk-based approach to assuring sterility of terminally sterilized, single-use health
care product that is unable to withstand processing to achieve maximally a sterility
−6
assurance level of 10 ”.
[8] Kilmer Conference Proceedings, http://www.aami.org/productspublications/content.
aspx?ItemNumber=2594. Accessed August 2, 2019.