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 does not address the identification or quantification of degradation products@ which is covered in ISO 10993-9@ ISO 10993-13@ ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices@ when carrying out a biological safety assessment.
EN ISO 10993-18:2009 history
2023EN ISO 10993-18:2020/A1:2023 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
2021EN ISO 10993-18:2020/prA1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021)
2020EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
2009EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
2005EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials