Biomedical Engineering Reference
In-Depth Information
- The class II b/high degree of risk - contains invasive devices of
long-term use (surgical implants, haemodialysis equipment, infusion
pumps, etc.);
- The class III/highest degree of risk - contains invasive devices of
short- or long-term used in contact with heart or central circulatory
(CCS)/nervous system (NCS) (stent, hip prosthesis), or devices
having a biological effect (administrator of medicine) or undergoing
chemical changes in body (biodegradable device). Class III devices
require premarket approval and preclinical and clinical assessments.
In addition to this classification, eighteen rules are edited in order
to help manufacturers determine the degree of risk provide by their
medical devices. In Europe, the safety of medical devices is assured
by the “EC labeling” of the European Community under the control of
National Agencies.
2.4. Other definitions: implant, prosthesis, organ, graft, etc.
Numerous terms are used when we speak about biomaterials.
Having defined above in an extensive way biomaterials and medical
devices, here is some essential terms frequently used in the
biomaterials domain having subtle differences. The aim is to provide
terminology usable without confusion. This is necessary
because (1) human health and environmental sustainability are more
and more interdependent, (2) research, applications, norms, and
regulations are still developed independently in each sector, and (3)
non-specialists like journalists, politicians, and partners of
complementary disciplines are more and more implicated and need a
common language.
Implant: An implant is a medical device (apparatus, delivery device,
prosthesis, organ etc.) made of one or several biomaterials, which is
introduced into the human body in the long term to replace an organ or
to supply a function or to treat a disease. It can be implanted inside the
body or under the skin (subcutaneous implant) or under an epithelial
surface. The implant can be temporary (contraceptive implant) or
permanent (dental implant, intra ocular lens).
