ISO 14607:2018 Annex H Surface characteristics*

The test for surface characteristics of breast implants according to ISO 14607:2018 primarily serves to classify the roughness according to which the implant is described as smooth, microtextured or macrotextured.
The roughness is measured on samples from various sampling locations on the implant. Due to the higher precision, we use the surface roughness measurement via laser microscope.
In addition, scanning electron micrographs are made of the implant surface. To do this, the samples must be sputtered with a thin, conductive gold surface.

Please get in touch to receive a quotation for classification of the surface of your products.

*We offer this testing service as part of our accredited scope.