Technical Bibliography

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ISO, 2018. ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Geneva: International Organization for Standardization.

ISO, 2010. ISO 10993-13:2010 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymers. Geneva: International Organization for Standardization.

ISO, 2009. ISO 14971:2019 - Risk management for medical devices. Geneva: International Organization for Standardization.

ISO, 2015. ISO 11137:2015 - Sterilization of health-care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Geneva: International Organization for Standardization.

ISO, 2006. ISO 11737:2018 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products. Geneva: International Organization for Standardization.

USP, 2024. General Chapter <87>: Biological Reactivity Tests, In Vitro. United States Pharmacopeia and National Formulary. Rockville: United States Pharmacopeial Convention.

USP, 2024. General Chapter <88>: Biological Reactivity Tests, In Vivo. United States Pharmacopeia and National Formulary. Rockville: United States Pharmacopeial Convention.

Genesis Medical Plastics, 2023. FDA Testing and Approval Processes for Implantable PEEK Devices. [Online] Available at: genesismedicalplastics.com [Accessed 10 November 2025].

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WKAi Global, 2024. PET Plastics in Various Industries: Medical Devices and Applications. [Online] Available at: wkaiglobal.com [Accessed 10 November 2025].

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FICTIV, 2025. POM (Acetal/Delrin®) Plastic: Properties, Advantages, and Applications. [Online] Available at: fictiv.com [Accessed 10 November 2025].

DuPont, 2025. Delrin® - High-Performance Acetal Homopolymer. [Online] Available at: delrin.com [Accessed 10 November 2025].

SMA Materials, 2024. Applications of Polytetrafluoroethylene (PTFE) in Medical Devices. [Online] Available at: samaterials.com [Accessed 10 November 2025].

Baron Blakeslee, 2024. The Significance of PTFE Coating on Medical Devices. [Online] Available at: baronblakeslee.net [Accessed 10 November 2025].

Colorado Plastics, 2016. Plastics for Medical Use - Material Selection Guide. [Online] Available at: coloradoplastics.com [Accessed 10 November 2025].

Curbell Plastics, 2025. Plastic Properties Table - Medical Grade Materials. [Online] Available at: curbellplastics.com [Accessed 10 November 2025].

Medical Institute, 2024. Navigating Biocompatibility: An Introduction to ISO 10993 Standards. [Online] Available at: medinstitute.com [Accessed 10 November 2025].

RIMSYS, 2023. ISO 10993: Standards for the Biologic Evaluation of Medical Devices. [Online] Available at: rimsys.io [Accessed 10 November 2025].

University of Minnesota, 2018. Biocompatibility of Polymer-Based Biomaterials and Medical Devices. [Online] Available at: saliterman.umn.edu [Accessed 10 November 2025].

Massachusetts Institute of Technology, 2020. Physical and Mechanical Properties of PLA and Their Evolution During Processing. [Online] Available at: dspace.mit.edu [Accessed 10 November 2025].

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Food and Drug Administration, 2025. FDA MAUDE Database - Medical Device Adverse Events. [Online] Available at: accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm [Accessed 10 November 2025].

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ISO, 2015. ISO 11137 - Sterilization of Health-care Products - Radiation. Geneva: International Organization for Standardization.

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