scope:

This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18.

The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2).