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Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

Karolina Jagiello, Anita Sosnowska, Alicja Mikolajczyk, Tomasz Puzyn
Copyright: © 2017 |Volume: 2 |Issue: 2 |Pages: 11
ISSN: 2379-7452|EISSN: 2379-7444|EISBN13: 9781522515982|DOI: 10.4018/JNN.2017070101
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MLA

Jagiello, Karolina, et al. "Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives." JNN vol.2, no.2 2017: pp.1-11. http://doi.org/10.4018/JNN.2017070101

APA

Jagiello, K., Sosnowska, A., Mikolajczyk, A., & Puzyn, T. (2017). Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives. Journal of Nanotoxicology and Nanomedicine (JNN), 2(2), 1-11. http://doi.org/10.4018/JNN.2017070101

Chicago

Jagiello, Karolina, et al. "Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives," Journal of Nanotoxicology and Nanomedicine (JNN) 2, no.2: 1-11. http://doi.org/10.4018/JNN.2017070101

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Abstract

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.

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