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EVS-EN ISO 10993-18:2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials

General information
Withdrawn from 15.06.2020
Base Documents
ISO 10993-18:2005; EN ISO 10993-18:2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.06.2020
Main
07.08.2009
Main
Main
EVS-EN ISO 10993-18:2005
This part of ISO 10993 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 (ISO 10993-17). - 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.
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