New ISO standard for chemical characterization of medical devices

ISO 10993-18:2020 is now official and sets the framework for chemical characterization of medical device materials in connection with biocompatibility evaluation within the risk management process.

The EU Medical Device Regulation (MDR) and ISO 10993-1:2018 on biological evaluation of medical devices increase the mandatory requirements for physical-chemical data and chemical analysis of devices.

The new standard explains the requirements and how to perform the chemical characterization by identification and quantification of chemical constituents in medical devices and materials. The standard provides more detailed guidance on chemical analyses of chemical characterization than the previous version of ISO 10993-18, including analyses of migration of substances (extractables).

The standard is available for purchase at ISO: ISO 10993-18:2020 standard or at Dansk Standard.

It is expected that the ISO standard will be published as a European Norm (EN) and Danish Standard (DS) following a harmonisation process.

For more information on ISO standards and chemical characterization, please contact:

Poul Bo Larsen
Tel +45 4516 9478