Shfuqizuar
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.
Directives related to this standards.
PUBLISHED
SSH EN ISO 10993-18:2009
WITHDRAWN
SSH EN ISO 10993-18:2007
95.99
Withdrawal of Standard
17 qer 2009