Reliable Design of Medical Devices
Fries , Arthur T. Through our network of over 44, people in 1, laboratories and offices in countries, Intertek provides quality and safety solutions to a wide range of industries around the world.
Find out more. Global Reach Intertek is the industry leader with over 44, people in 1, locations in over countries.
Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. Ensuring Safety and Essential Performance: Medical Devices Used in the Home Medical devices used for home healthcare are designed to specifically to ensure safety. Key design considerations include: All cord connected home healthcare products need to use a two-prong unearthed plug classified as Class II equipment, in accordance with , Third Edition, which means the use of a protective earth conductor is not allowed as a means of protection.
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Reliable design of medical devices pdf download
Bibliography Includes bibliographical references and index. Introduced nearly a decade ago, "Reliable Design of Medical Devices" illuminated the path to increased reliability in the hands-on design of advanced medical devices.
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- Reliable Design of Medical Devices.
With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail.
It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing.
Supplying valuable insight based on years of successful experience, "Reliable Design of Medical Devices, Second Edition" leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.