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

رقم المستند: NL ISO 10993 18 : 2009
القطاع: Health Care Technology
TC: NL TC 3001
ICS: 11.100.20
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. This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.