biocompatibility
Beginner
Making sure the materials that touch the body don’t harm it, for example by causing swelling or poisoning.
Novice
Whether the materials that touch the body cause harm, such as irritation, toxicity or an immune reaction. It is evaluated under the standard ISO 10993-1, as part of a risk analysis.
Expert
Drives package materials, coatings and electrode metals, and any material change can reopen the biological evaluation.
Explained in Medical devices (Industries).