Page 234 - Safety Risk Management for Medical Devices

CHAPTER 29

Relationship Between ISO 14971

and Other Standards

Abstract
ISO 14971, the central Standard for medical device risk management, works in concert with many
other related Standards. In this chapter we examine the relationships between ISO 14971 and IEC
60601-1, ISO 10993-1, IEC 62366, and ISO 14155.
Keywords: IEC 60601-1; ISO 10993-1; IEC 62366; ISO 14155

As mentioned in Chapter 5, Risk Management Standards, a number of safety-related
Standards rely on ISO 14971 for determination of safety risks. In the following sub-
sections, the relationships between ISO 14971 and IEC 60601-1, ISO 10993-1, IEC
62366, and ISO 14155 are described.

29.1 INTERACTION WITH IEC 60601-1
IEC 60601-1 [8] is related to general requirements for basic safety and essential perfor-
mance of Medical Electrical equipment (ME), and is intended for the
nonimplantable MEs.
IEC 60601-1 [8] makes a normative reference to ISO 14971 [3] and expects the
performance of risk management per Ref. [3].
IEC 60601-1 [8] specifies certain requirements and acceptance criteria that facili-
tate the risk management process. For example, there are detailed requirements in
Ref. [8] for protection against electric shock. Test equipment, measurement methods,
and pass criteria are provided in the Standard [8]. Therefore if a medical device is
compliant with IEC-60601-1 [8], it can claim that the risk of electric shock from the
device is acceptable.
In other cases, e.g., with respect to the safety of emitted ultrasound energy from a
medical device, Ref. [8] does not offer any means of testing for safety or acceptance
criteria. Instead, it defers to the risk management process per ISO 14971 [3].
In some cases, the determination of whether certain aspects of the medical device
design are subject to IEC 60601-1 [8] is left up to the risk management process. For
example, “applied part” has a special meaning in Ref. [8]. It is the part of the device

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00029-5 All rights reserved. 213