The DOI matches its Crossref record; 37 of the 39 references it cites were found in a registry or an index.
Sterilization of implantable polymer-based medical devices: A review
Abstract
This review article is focused on the sterilization techniques used for polymer-based implantable medical devices as well as the regulatory aspects governing sterile medical devices. Polymeric materials are increasingly used in implantable devices due to their biodegradable and biocompatible nature. Patients and medical staff often prefer long-term implantable devices and these can be achieved using high molecular weight polymers. Sterilization of polymer-based implantable devices is critical. Since all implantable devices must be sterile, the effect of the sterilization method on the different device components (such as, the polymer, the drug, the electronics, etc.) has to be considered. A comprehensive summary of the established sterilization methods is provided along with the possible effects on polymers. In addition, novel sterilization methods are also discussed.
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“The selection of the sterilization method reflects material choice of the implants with polymers; e.g. gamma irradiation is fast and efficient, but can degrade polymers through 'cross-linking, chain scission or a combination of both' (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
In the citing paper
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
In the citing paper
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
In the citing paper
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
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Metadata
- Authors
- Tipnis, N. P., & Burgess, D. J.
- Affiliations
- University of Connecticut (US)
- Corresponding author
- Burgess, Diane J.
- Venue
- International Journal of Pharmaceutics
- Publisher
- Elsevier BV
- Published
- 2018-06
- Volume
- 544
- Issue
- 2
- Pages
- 455-460
- ISSN
- 0378-5173 (ISSN-L)
- OpenAlex
- W2780274668
- Cited by
- 233
- References
- 39
- Citations by year
- 2026: 19 · 2025: 32 · 2024: 32 · 2023: 36 · 2022: 28 · 2021: 28 · 2020: 26 · 2019: 19 · 2018: 13
- FWCI
- 12.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Pharmaceutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Microbiology › Medical Device Sterilization and Disinfection
- Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antimicrobial agents and applications
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Keywords
- sterilization, biomedical implants, sterilization methods, biodegradable polymers, biocompatibility, drug-loaded implants
- MeSH terms
- Biocompatible Materials, Equipment Contamination, Polymers, Sterilization, United States, United States Food and Drug Administration, Guidelines as Topic, Prostheses and Implants
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