SRPS EN ISO 10993-18:2008

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

Scope

This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.