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Hazardous Chemicals in Medical Devices. Safety, Risk Analysis, and Regulations

  • Book

  • September 2025
  • Elsevier Science and Technology
  • ID: 6057664
Hazardous Chemicals in Medical Devices: Safety, Risk Analysis, and Regulations provides a comprehensive overview of the hazardous chemicals used in medical device manufacturing. The book discusses the basics of these chemicals, their presence in various components, and the regulations that govern their use. It also delves into the processes involved in manufacturing and the added chemicals during these stages. With a focus on risk assessment and analysis, the book emphasizes the importance of safety in medical devices and outlines the types of hazards associated with these substances.

The book further explains the regulatory classification of hazardous chemicals and the labeling and safety data sheet requirements. It includes a list of notified bodies that discuss hazardous substance data, aiding in risk assessment and toxicological profiling. Additionally, it underscores the critical understanding of toxicological profiles of materials used in medical devices, ensuring that readers are well-informed about the safety measures and regulations in place to protect both manufacturers and users.

Table of Contents

1. Introduction to Hazardous Chemicals
2. Hazardous Materials/Material Composition
3. Hazardous Chemicals Through the Manufacturing Process
4. Hazardous Classifications and Symbols
5. Material Procurement Process
6. Biological Impact of Hazards
7. Regulatory Requirements for Risk Management

Authors

Prakash Srinivasan Timiri Shanmugam Senior Toxicologist, Avanos Medical, Inc., Georgia, USA. Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME-Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts. Thamizharasan Sampath Dean of Research and Professor, Department of Pharmacology & Toxicology, Shri Balaji Institute of Medical Sciences, University of Health Sciences, Raipur, Chhattisgarh, India. Thamizharasan Sampath, PhD, PGDCR, is currently Dean of Research and Professor of Pharmacology & Toxicology at the University of Health Sciences (SBIMS), Raipur, CG, India. He has done his MS and PhD specializing in pharmacology under the faculty of medicine from the Post Graduate Institute of Basic Medical Sciences, University of Madras, and also did his Postgraduate diploma in clinical research at State University. He has 17 years of teaching and research experience. His research areas include cancer pharmacology, clinical research, neurotoxicology, nutraceuticals, reproductive toxicology, endocrine pharmacology, phytopharmacology, molecular pharmacology, drug design, and drug discovery. He has published more than 60 research articles in national and international indexed journals and is the author of the book Bamboo - The Golden seed and has also contributed more than 20 book chapters. He has received many awards from various central organizations for his outstanding research and contribution in the field of medicine. He serves as a Chief Editor, Editorial Board Member, and Reviewer in many medical journals. He is a member of Institutional Research Ethics Committee, Animal Ethics Committee, Indian Pharmacological Society, and UNESCO Bioethics Committee.