ABSTRACT
A medical device is expected to be not only reliable but also safe. This means that a given medical device must never function or malfunction in a manner that can be harmful to the user or the patient. The problem of safety in regard to humans is not new; its history can be traced back to the ancient Babylonian ruler Hammurabi, who developed a code known as the “Code of Hammurabi” in 2000 b.c. [1-3]. The code contained clauses concerning injury and nancial damages against those individuals who cause injury to other people.
