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Hazardous Chemicals in Medical Devices
Safety, Risk Analysis, and Regulations
- 1st Edition - September 1, 2025
- Authors: Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 3 4 1 5 4 - 0
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 3 4 1 5 5 - 7
"Hazardous Chemicals in Medical Devices: Safety, Risk Analysis, and Regulations" educates readers about the basics of hazardous chemicals, the hazardous chemicals present in most o… Read more
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Request a sales quote"Hazardous Chemicals in Medical Devices: Safety, Risk Analysis, and Regulations" educates readers about the basics of hazardous chemicals, the hazardous chemicals present in most of the components used to manufacture a medical device, regulations regarding hazardous chemicals, and hazardous chemicals added during manufacturing processes. The book describes the risk assessment and analysis of hazardous chemicals in medical devices, defines the types of hazards, and elaborates on the importance of medical device safety. It covers the hazardous chemicals present in the manufacturing and sterilization processes. It also explains how regulations classify hazardous chemicals and the types of labelling and safety data sheet requirements. In addition, it provides a list of notified bodies discuss the data of hazardous substances that aid in risk assessment and toxicological profile generation and the importance of understanding the toxicological profiles of materials used in medical devices.
• 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 safety of medical devices.
• Lists the regulatory requirements, guidelines, and organizations involved in monitoring hazardous substances.
• Discusses the hazardous chemicals and composition present in the materials and the significance of material procurement to ensure safety of medical devices.
• Lists the regulatory requirements, guidelines, and organizations involved in monitoring hazardous substances.
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.
Chapter 1 Introduction to Hazardous Chemicals
Chapter 2 Hazardous Materials/Material Composition
Chapter 3 Hazardous Chemicals Through the Manufacturing Process
Chapter 4 Hazardous Classifications and Symbols
Chapter 5 Material Procurement Process
Chapter 6 Biological Impact of Hazards
Chapter 7 Regulatory Requirements for Risk Management
Chapter 2 Hazardous Materials/Material Composition
Chapter 3 Hazardous Chemicals Through the Manufacturing Process
Chapter 4 Hazardous Classifications and Symbols
Chapter 5 Material Procurement Process
Chapter 6 Biological Impact of Hazards
Chapter 7 Regulatory Requirements for Risk Management
- No. of pages: 200
- Language: English
- Edition: 1
- Published: September 1, 2025
- Imprint: Academic Press
- Paperback ISBN: 9780443341540
- eBook ISBN: 9780443341557
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Prakash Srinivasan Timiri Shanmugam
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.
Affiliations and expertise
Senior Toxicologist, Avanos Medical, Inc., Georgia, U.S.ATS
Thamizharasan Sampath
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.
Affiliations and expertise
Dean of Research and Professor, Department of Pharmacology & Toxicology, Shri Balaji Institute of Medical Sciences, University of Health Sciences, Raipur, Chhattisgarh, India