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38 Assurance of sterility for sensitive combination products and materials

[16] K. Suzuik (Ed.), Vol. 4, in: Selected Papers in Biochemistry, Radiation Biology of Mi-
croorganisms, University Press, Baltimore, London, Tokyo, 1971.
[17] ISO/ASTM 52628, Standard Practice for Dosimetry in Radiation Processing, ASTM
International, West Conshohocken, PA, 2013, p. 2013.
[18] ISO/IEC 17025:2005, General Requirements for the Competence of Testing and
Calibration Laboratories.
[19] 21CRF 820.72 Title 21, Chapter I – Food and Drug Administration, Department of
Health and Human Services, Subchapter H-Medical Devices, Part 820, Subpart G –
Production and Process Controls, Inspection, measuring, and test equipment.
[20] ISO 11137-2 Sterilization of Health Care Products-Radiation-Part 2: Establishing the
Sterilization Dose.
[21] United States Pharmacopeia National Formulary (USP40-NF35) 2017, Sterility Tests
<71>.
[22] ANSI/AAMI/ISO 11138-1:2017, Sterilization of Health Care Products-Biological
Indicators-Part1: General Requirements.
[23] ANSI/AAMI/ISO TIR11139:2006, Sterilization of Health Care Products—Vocabu-
lary.
[24] ISO 10993-7: 2008 Biologic evaluation of medical devices-Part 7: Ethylene oxide
sterilization residuals.
[25] ANSI/AAMI ST72:2011 Bacterial Endotoxins-Test Methods, Routine Monitoring,
and Alternatives to Batch Testing.
[26] E. Daniell, T. Bryans, K. Darnell, J. Hansen, V.M. Hutchins, M. Saavedra, Product Ste-
rility Testing… to Test or Not to Test? That Is the Question, in: Industrial Sterilization,
Sep 2016.
[27] B. Lambert, T. Mendelson, M.D. Craven, Radiation and ethylene oxide terminal steri-
lization experiences with drug eluting stents, AAPS PharmSciTech 12 (4) (Dec 2011).
[28] https://www.fda.gov/downloads/MedicalDevices/.../ucm109897.pdf.
[29] AAMI TIR 17: 2008, Compatibility of materials subject to sterilization.
[30] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3225553/.
[31] https://www.fda.gov/medicaldevices/digitalhealth/.

Further reading
[32] Guidance for Industry and FDA Staff, Current Good Manufacturing Practice Require-
ments for Combination Products, US Department of Health and Human Services,
Food and Drug Administration, Office of Combination Products (OCP) in the Office
of the Commissioner, Center for Biologics Evaluation and Research (CBER), Center
for Drug Evaluation and Research (CDER), Center for Devices and Radiological
Health (CDRH), Office of Regulatory Affairs (ORA), Final Guidance, January 2017.
[33] B.J. Lambert, T.A. Mendelson, M.D. Craven, Radiation and ethylene oxide terminal
sterilization experiences with drug eluting stent Products, AAPS PharmSciTech 12 (4)
(2011) 1116–1126, https://doi.org/10.1208/s12249-011-9644-8.
[34] B.J. Parsons, Sterilization of drug-device combination products, in: A. Lewis (Ed.),
Drug-device Combination Products, Woodhead, Cambridge, 2010, pp. 395–435.
[35] B.J. Parsons, Sterilization of healthcare products by ionizing radiation: Sterilization of
drug-device products and tissue allografts, in: S. Lerouge, A. Simmons (Eds.), Steriliza-
tion of Biomaterials and Medical Devices, Woodhead, Oxford, Cambridge, Philadel-
phia, New Delhi, 2012, pp. 212–234.
[36] ISO 14937:2009, Sterilization of health care products — General requirements for
characterization of a sterilizing agent and the development, validation and routine
control of a sterilization process for medical devices.