Biomedical Engineering Reference
In-Depth Information
infections are one of first causes of nosocomial bacteraemia and are
responsible for a significant mortality.
For several years, researchers have worked on the functionalization
of biomaterial surfaces in order to prevent infection [BER 02, MIG
06, CRE 03, PAV 01, PIC 12]. The advantages of these prevention
methods are numerous but one is worthy of note: it may prevent the
use of antibiotics and thus help in the fight against bacterial resistance
to antibiotics, which is a major problem for public health.
4.7. Norms and biocompatibility?
As biomaterials belong to the medical device family, they have to
follow the requirements of the different classes of medical devices
described in ISO NORMS EN ISO 10993. The classification dividing
the medical devices in class I to III as a function of the risk
encountered by the patient and the ISO NORMS gives the guidelines
to establish the assessments to be done on one biomaterial depending
on its application: the
in vitro
and
in vivo
experiments are precisely
described for each class of biomaterial as a function of its application.
These norms and the norms developed in other countries such as
European countries respond to the necessity of guaranteeing the
quality of the biomaterials that are proposed to the surgeons for short-
or long-term implantations
.
Each new material, each new
functionalization process or each change in the composition of a
material or a biomaterial needs a new evaluation of its performance
when placed in contact with a biological and living system.
The European EN ISO 10993 Norms group 20 parts (see
Table 4.2) which specify and detail the different series of standard
methods of evaluation of biocompatibility a medical device has to
pass prior to clinical studies; in the case of passing all the tests, the
medical device can be CE marked. The CE marking provides
an indication that the assessments have been carried out, before the
product is placed on the market. It must be affixed visibly to
the product. All these rules make it possible to ensure its compliance
with the legislative requirements.
