Biocompatibility testing for medical textile products

Biocompatibility is defined as a measurement of how compatible a material or a device is with a biological system. With medical textile products, the purpose of performing biocompatibility testing is to determine their fimess for human use, and to see whether their use can have any potentially harmful physiological effects. In this respect, medical textile products share the same requirement for biocompatibility as medical devices. 

The International Organization for Standardization (ISO) developed a series of standards for evaluating the biocompatibility of a medical device prior to a clinical study. In particular, ISO 10993-1 2009 clearly outlined its primary aim as the protection of humans from potential biological risks arising from the use of medical devices. 

Medical Textile Materials. http //dx.doi.Org/10.1016/B978-0-08-100618-4.00014-5 Copyright 2016 Elsevier Lid. All rights reserved. 

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After a brief introduction to the human body, the book gives an overview of medical textile products and the processes used to manufacture them. Subsequent chapters cover superabsorbent textiles, functional wound dressings, bandages, sutures, implants, and other important medical textile technologies in detail. Biocompatibility testing and regulatory control are then addressed, and the book finishes with a review of research and development strategy for medical textile products. 

Biocompatibility testing is an essential requirement for regulatory approval of medical devices such as medical textile products, and it is important to follow strict testing protocol in order to avoid potential pitfalls that could delay a product launch. During the product development process, it would be sensible to start the process early enough to allow for thorough and complete testing. As with any business or scientific endeavor, it is important to communicate all details accurately and be as up to date as possible on all test requirements. It is often necessary to consult qualified professionals to provide the expertise that is required for the successful completion of the various tests. 

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