29.1 Introduction

The beginning of the human reliability field may be taken as the middle of the 1950s when the problem of human factors was seriously considered and the first human-engineering standards for the US Air Force were developed [1, 2]. In 1958, the need for human reliability was clearly identified [3] and some findings relating to human reliability were documented in two Convair-Astronautifcs reports [4, 5].

In 1962, a database ( i.e. Data Store) containing time and human performance reliability estimates for human-engineering design features was established [6]. In 1986, the first book on human reliability was published [7]. All in all, over the years many other people have contributed to the field of human reliability and a comprehensive list of publications on the subject is given in [8].

The latter part of the 1960s may be regarded as the beginning of the medical device reliability field. During this period many publications on the subject appeared [9 13]. In 1980, an article listed most of the publications on the subject and in 1983, a book on reliability devoted an entire chapter to medical device/equipment reliability [14, 15]. A comprehensive list of publications on medical device reliability is given in [16].

This chapter presents various aspects of human and medical device reliability.

29.2 Human and Medical Device Reliability Terms and Definitions

Some of the common terms and definitions concerning human and medical device reliability are as follows [7, 15, 17 23].

• Human reliability. This is the...