ISO 10993-1:2018(E)
Introduction
from the use of medical devices. It is compiled from numerous International and national standards
and guidelines concerning the biological evaluation of medical devices. It is intended to describe the
evaluation and development of each medical device. This approach combines the review and evaluation
consisting of numerous components made of more than one material.
3.14
in vitro
and ex vivo
of response to the same material among individuals indicate that some patients can have adverse
in vitro
in vivo models.
Informative
management process to medical devices which encompasses biological evaluation.
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