9

Standards and methods for assessing the safety and biocompatibility of biomaterials

S.C. Gad,     Gad Consulting Services, USA

Abstract:

Evaluation of biocompatability of medical devices and biomaterials to meet regulatory requirement starts with consideration of the ISO-10993 guidance (as currently revised) and relevant local expectations such as the FDA G-95 Memorandum requirements. All of these require one to consider the type and duration of potential patient exposure, then to conduct required testing, and finally to do an integrated risk assessment based on the data collected. This chapter seeks to summarize that effort.

Key words

ISO-10993

FDA G-95-1

USP

biocompatability

foreign body response

innate immunity

9.1 Introduction

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