Abstract
Standards are important tools in evaluating and predicting the performance of medical devices prior to implantation. There are three types of standards that are available: a material specification, a standard test method, and a standard test guide. Each of these types of standards is defined with examples of how each is used to facilitate evaluation of medical devices. The standards development process is also described: this is a complex process, requiring the involvement of a multidisciplinary team, usually consisting of engineers, scientists, and clinicians who represent healthcare, academia, government, and industry. Finally, standards have a clear and defined role in the development of medical devices, and the benefits, strengths, as well as the limitations in this role are discussed.
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