ISO 10993-18:2005 PDF

Scope: 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.

ISO 10993-18:2005 Referenced Document

ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 14971:2000 Medical devices - Application of risk management to medical devices

2022 ISO 10993-18:2020/Amd 1:2022 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
2020 ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
2005 ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials