BS EN ISO 10993-18:2009

BS EN ISO 10993-18:2009 Biological evaluation of medical devices. Chemical characterization of materials BS EN ISO 10993-18 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:

As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971) Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment () Judging equivalence of a proposed material to a clinically established material Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former Screening of potential new materials for suitability in a medical device for a proposed clinical application.