Page 62 - Safety Risk Management for Medical Devices

CHAPTER 9

Biocompatibility and Risk Management

Abstract
The International Standard ISO 10993-1 is intended for the protection of humans from potential
biological risks from the use of medical devices. It describes the process for biological evaluation of
medical devices within the framework of a risk management process. ISO 10993-1 describes biologi-
cal evaluation of medical devices as a design verification activity in the broader context of risk man-
agement, which is governed by ISO 14971.
Keywords: Biocompatibility; biological testing; ISO 10993; biological hazards

The International Standard ISO 10993-1 [15] is intended for the protection of
humans from potential biological risks from the use of medical devices. It describes
the process for biological evaluation of medical devices within the framework of a risk
management process.
Annex B of the Standard [15], describes biological evaluation of medical devices as a
design verification activity in the broader context of risk management, which is gov-
erned by ISO 14971 [3,7]. Annex B includes guidance on the application of ISO
14971 [3,7] to the conduct of biological evaluation.
Sections B.2 and B.3 of Annex B of ISO 10993-1 [15] describe “a continuous
process by which a manufacturer can identify the biological hazards associated with
medical devices, estimate and evaluate the risks, control these risks, and monitor the
effectiveness of the control.”
In general manufacturers aim to use existing materials that are proven to be
acceptably safe for medical use from a biological perspective. However, at times it
could be found that existing proven materials are not suitable for the specific medical
device at hand.
When selecting a material for a medical device which would come in contact
with the patient, particularly for implantable devices, it is important that all Hazards
due to the use of the selected materials be identified, and the risks for each Hazard be
estimated and evaluated.
Application of ISO 14971 [3] risk management methodology can identify, estimate,
and evaluate the risks due to biological hazards and judge their acceptability.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00009-X All rights reserved. 41