Mission-Critical and Safety-Critical Systems Handbook

CHAPTER 3

Compliance Concerns for Medical Equipment

Brian Biersach and Jeremi Peck

1. Introduction

Medical equipment is highly regulated by all countries, and held to a higher level of safety than nearly all other equipment on the market. The main reasons for this are that medical equipment may be used on patients who are not able to respond to hazardous conditions or pain; an actual electrical connection between the equipment and patient may exist; patient treatment may be based on the output of the medical device; and certain types of medical equipment function as life support, the failure of which could result in the death of the patient. Understanding these requirements early in the design process will result in lower product development ...