Page 232 - Safety Risk Management for Medical Devices

CHAPTER 28

Basic Safety and Essential Performance

Abstract
Basic Safety and Essential Performance are key concepts in medical device risk management. This
chapter gives guidance on how to identify Basic Safety and Essential Performance, and how to dis-
tinguish them from each other.
Keywords: Basic Safety; Essential Performance; IEC 60601-1

IEC 60601-1 [8] is the Standard for nonimplantable medical electrical equipment.
Ref. [8] defines two special terms:

• Basic Safety: “freedom from unacceptable risk directly caused by physical
hazards when me equipment is used under normal condition and single fault
condition” [8] 3.10.
• 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.
NOTE Essential Performance is most easily understood by considering
whether its absence or degradation would result in an unacceptable risk” [8] 3.27.

Understanding, and the ability to identify the Basic Safety and Essential
Performance of your medical device is essential to your ability to demonstrate compli-
ance to [8].

28.1 HOW TO IDENTIFY BASIC SAFETY

Consider your medical device while it is not performing its clinical function. Analyze
for all the relevant requirements of IEC 60601-1 [8] and determine if the device
under normal and single fault conditions could pose a Hazard. This is the basis of
identification of Basic Safety of your device.

28.2 HOW TO IDENTIFY ESSENTIAL PERFORMANCE

Essential performance is about clinical functions of the device. Follow these steps:
1. Make a list of all your clinical functions.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00028-3 All rights reserved. 211