ISO 10993, Part 18: A structured approach to material characterisation

Abstract

A well-constructed and executed biological risk analysis can provide a level of assurance that a particular material can be safely used for a medical device. If the data needed to conduct this analysis are not readily available, ISO 10993 Part 18 outlines a framework for the programme of tests required to chemically characterise the materials and generate the information. Companies involved in the specification of materials for new medical devices should prepare for the introduction of Part 18 by reviewing their relationships with material suppliers, assessing the scope and detail of the information that is available and making provision for any additional testing requirements that may be required.