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Elsevier

Hazardous Chemicals in Medical Devices

Safety, Risk Analysis, and Regulations

  • 1st Edition - October 15, 2025
  • Latest edition
  • Authors: Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath
  • Language: English

Hazardous Chemicals in Medical Devices: Safety, Risk Analysis, and Regulations provides a comprehensive overview of the hazardous chemicals used in medical device manufa… Read more

Description

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.

Key features

  • Describes how hazardous chemicals are added in the manufacturing and process
  • Discusses the hazardous chemicals and composition present in the materials and the significance of material procurement to ensure the safety of medical devices
  • Lists the regulatory requirements, guidelines, and organizations involved in monitoring hazardous substances

Readership

Researchers studying medical devices and hazardous substances, academics teaching courses in toxicology, biomedical engineering, regulatory affairs, or related fields, industry professionals involved with assessment of toxicological profiles and risk analysis, Government or regulatory authorities responsible for ensuring compliance with safety standards and regulations.

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

Product details

  • Edition: 1
  • Latest edition
  • Published: October 28, 2025
  • Language: English

About the authors

PT

Prakash Srinivasan Timiri Shanmugam

Prakash Srinivasan Timiri Shanmugam, PhD, ERT, is a Biocompatibility Scientist in industry. He has more than 18 years of experience in toxicology, biocompatibility, medical devices, and chemical characterization. He previously served as a Senior Toxicologist at Avanos Medical and as a toxicology and biocompatibility consultant for Baxter International and Johnson & Johnson. He earned his MS and PhD in Pharmacology and Toxicology with an interdisciplinary specialization in Chemistry from the University of Madras and completed postdoctoral research at Tulane University and LSU Health Sciences Center Shreveport. His expertise includes extractables and leachables, toxicokinetics, systemic toxicity, carcinogenicity, cytotoxicity, pathology, analytical chemistry, and biological safety evaluation in accordance with ISO, GLP, and global regulatory standards. He has validated chemical characterization methods using gas and liquid chromatography and possesses extensive experience with medical device safety assessments. Dr. Shanmugam is the editor of eight books, author of several book chapters, and has published widely in peer-reviewed journals and conference proceedings.

Affiliations and expertise
Biocompatibility Scientist, GE Healthcare, Alpharetta, Georgia, USA

TS

Thamizharasan Sampath

Thamizharasan Sampath, PhD, PGDCR, is Professor of Pharmacology and Toxicology at VBMC & GH, Dr. NTR University of Health Sciences, Kurnool, India. He previously served as Dean of Research and Professor of Pharmacology & Toxicology at the University of Health Sciences (SBIMS), Raipur, India. He earned his MS and PhD in Pharmacology from the University of Madras and completed both a postdoctoral fellowship and postgraduate diploma in clinical research. With nearly 18 years of teaching and research experience, his expertise includes clinical research, neurotoxicology, nutraceuticals, reproductive toxicology, endocrine and molecular pharmacology, phytopharmacology, medical devices, and drug discovery. Dr. Sampath has published in peer-reviewed journals, authored book chapters and has edited several scientific works, including the Elsevier titles Biocompatibility Protocols for Medical Devices and Materials and Hazardous Chemicals in Medical Devices. He also serves as a journal editor, reviewer, and is an active member of research ethics, animal ethics, pharmacological, and bioethics committees.

Affiliations and expertise
Professor of Pharmacology and Toxicology,VBMC & GH, Dr. NTR University of Health Sciences, Kurnool, India

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