Hazardous Chemicals in Medical Devices
Safety, Risk Analysis, and Regulations
- 1st Edition - October 10, 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 provides a comprehensive overview of the hazardous chemicals used in medical device manufa… Read more
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.
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.
- 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
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.
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
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
- Edition: 1
- Published: October 10, 2025
- Language: English
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Prakash Srinivasan Timiri Shanmugam
Prakash Srinivasan Timiri Shanmugam, PhD., ERT, is currently a Senior Toxicologist at Avanos Medical, Inc. in Georgia, United States. He was previously contracted as an SME– Biocompatibility at Baxter International, Inc., Illinois, USA and Project Manager/Biocompatibility to the Johnson & Johnson Medical Device Sector, Massachusetts, USA. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, India and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He is an editor of seven books, and author of several book chapters. He has published research articles in various peer-reviewed international journals and conference proceedings/abstracts.
Affiliations and expertise
Senior Toxicologist, Avanos Medical, Inc., Georgia, USATS
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