Biomedical Product and Materials Evaluation

Standards and Ethics

Häftad, Engelska, 2022

AvP.V. Mohanan,India) Mohanan, P.V., PhD (Scientist-G and Head, Toxicology Division, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India,P. V. Mohanan

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Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation.

This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology.

Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more
Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies
Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Produktinformation

Utgivningsdatum2022-01-24
Mått152 x 229 x undefined mm
Vikt1 000 g
FormatHäftad
SpråkEngelska
SerieWoodhead Publishing Series in Biomaterials
Antal sidor806
FörlagElsevier Science
ISBN9780128239667

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Dr. Mohanan FNASc, is the Head of the Division of Toxicology, Sree Chitra Tirunal Institute for Medical Sciences and Technology (Govt. of India). He is a visiting professor and visiting researcher at Toyo University, Japan and a Certified Biological Safety Specialist. Previously, he was a JSPS Post doctoral Fellow at the University of Tsukuba, Japan in the field of Neurotoxicity. He joined Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India in 1989 and has spent 33 years of professional life working there. As a toxicologist he has been intimately associated with all the medical devices/technologies developed at SCTIMST. He received the lifetime achievement award from the Society of Toxicology India, for the outstanding contribution in the field of toxicology. He also patented an ELISA kit for the measurement of pyrogenicity. Mohanan made significant contributions for the development of medical device regulations in India. He has authored 231 publications and edited 6 books. Presently he is the secretary general of the Society of Toxicology, India.

1. Materials for medical products2. Ethical issues in animal experimentation3. Ethical issues in product development4. 3D printed organs for healthcare applications5. Wound care products6. Blood derived products7. Medical products from stem cells8. Decellularised tissue products9. Combinational products10. Diagnostic assays as product development11. Characterization of cells and animals used in experimentation12. Product evaluation: Cytotoxicity assays13. Product evaluation: Blood compatibility studies14. Product evaluation: Microbial studies15. Product evaluation: Safety and toxicity studies16. Product evaluation: Histopathological studies17. 3D printed organs for toxicity assays18. Organ-on-a-chip for toxicity evaluation19. In vitro alternative techniques20. Neurotoxicity assay21. Regulatory issues in biological products22. Sterilization for biological products

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