ISO 10993-18:2005

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

Publication date:   Jun 30, 2005

95.99 Withdrawal of Standard   Jan 13, 2020

General information

95.99 Withdrawal of Standard   Jan 13, 2020

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

ISO 10993-18:2005 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), as a 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), for judging equivalence of a proposed material to a clinically established material, for 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, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
ISO 10993-18:2005 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).
ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Life cycle

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WITHDRAWN
ISO 10993-18:2005
95.99 Withdrawal of Standard
Jan 13, 2020

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PUBLISHED
ISO 10993-18:2020