Hazardous Chemicals in Medical Devices

Hazardous Chemicals in Medical Devices: Safety, Risk Analysis, and Regulations offers an overview of 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 labeling and safety data sheet requirements. In addition, the book provides a list of which notified bodies discuss the data of hazardous substances, aiding 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 the safety of medical devices
• Lists the regulatory requirements, guidelines, and organizations involved in monitoring hazardous substances