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CHAPTER 3
The Basics
Abstract
As in any other discipline, risk management also has its own jargon, or special vocabulary. It is
imperative that you learn this vocabulary and use it correctly and consistently. Without this com-
mon language, it is not possible to reliably convey meaning. This increases the probability of mis-
communication, confusion and the potential for errors.
Keywords: Vocabulary; reasonably foreseeable misuse; hazard theory; integral system; distributed
system
3.1 VOCABULARY OF RISK MANAGEMENT
As in any other discipline, risk management also has its own jargon, or special vocabulary.
It is imperative that you learn this vocabulary and use it correctly and consistently. Just as
important, you should teach this vocabulary to others who participate in producing
risk management work products. Without this common language, it is not possible to
reliably convey meaning. This increases the probability of miscommunication, confusion
and the potential for errors. Table 3.1 lists some of the most commonly used terms in
medical device risk management.
Table 3.1 Special vocabulary of risk management
Term Definition
Basic Safety freedom from unacceptable risk directly caused by physical hazards
when ME equipment is used under normal condition and single
fault condition [8]
Essential Performance performance of a clinical function, other than that related to basic
safety, where loss or degradation beyond the limits specified by
the manufacturer results in an unacceptable risk [8]
Expected Service Life time period specified by the manufacturer during which the
medical electrical equipment or medical electrical system is
expected to remain safe for use (i.e. maintain basic safety and
essential performance)
NOTE: Maintenance can be necessary during the expected service
life. [8]
Failure the inability of an entity to achieve its purpose
(Continued)
Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00003-9 All rights reserved. 9
