ABSTRACT

In general, a medical device is defined as follows: a medical device is an implant and equipment to be used either to achieve disease diagnosis, medical treatment, or disease prevention for human and animals, or to influence the physical structure and function of human and animals. Medical devices for humans may also be classified based on whether and how long the device is in contact with tissue or cells and on the degree of disjunction induced by the device when in a disabling situation. The term covers various categories, such as scissors and tweezers, with small risk to human function, to central venous catheters, artificial dialysis (human kidney), and pacemakers, with high risk to human function.