Page 44 - Safety Risk Management for Medical Devices

CHAPTER 5

Risk Management Standards

Abstract
There are a number of standards that address safety for medical devices. For example, ISO 14971,
IEC 60601-1, IEC 62304, IEC 62366, ISO 10993-1, and so on. ISO 14971 is the central standard for risk
management of medical devices and is recognized both in the EU and the United States.
Compliance with ISO 14971 is the most common way of establishing the case for the safety of a
medical device.
Keywords: ISO 14971; IEC 60601-1; EN ISO 14971:2012

There are a number of standards that address safety for medical devices. For example,
ISO 14971 [3,7], IEC 60601-1 [8], IEC 62304 [9], IEC 62366 [14], ISO 10993-1
[15], and so on (see Fig. 5.1). ISO 14971 is the central standard for risk management
of medical devices and is recognized both in the EU and the United States. Other
medical device safety standards make normative references to ISO 14971 [3,7]. ISO
14971 [3,7] defines a set of requirements for performing risk management, but does
not stipulate any specific process.
Most of the safety standards are becoming progressively more outcome-based and
less prescriptive. They specify what outputs are expected, and give you the freedom
to choose your own methods. This is both a blessing and a curse. On the one hand,
you get freedom to create your own process. On the other hand, the standards don’t
tell you how to do things, so the method that you choose becomes subject to ques-
tioning and you must be prepared to defend it.
For all regulated medical devices, the manufacturers must show that formal risk
management processes have been applied and that their respective safety risks have
been reduced to acceptable levels.

5.1 ISO 14971 HISTORY AND ORIGINS

ISO 14971 was originally developed in 1998 with participation from 112 countries. It
is widely recognized as the official international standard for medical device risk
management.
To produce ISO 14971, ISO/TC 210 WG4 was formed. Simultaneously IEC
60601-1 3rd edition was planning to include risk management for medical devices. In

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00005-2 All rights reserved. 23