Biomedical Engineering Reference
In-Depth Information
prevent early degradation of the material and release of degradation
products and compounds in the body
[LER 12].
Then, among the different sterilization processes, the choice will
be made according to the physico-chemical characteristics of the
devices as well as the facilities where the sterilization will be carried
out - research laboratory, surgery, industrial plant, hospital. All these
parameters have to be pointed out because the advantages and
disadvantages of sterilization can affect the in fine “biocompatibility”
of the material and any biomaterials
have to be conceived bearing in
mind its sterilization process
.
Some major questions have to be answered and taken into account:
- sterilization process and results as part of the biocompatibility
evaluation of a biomaterial;
- methods of sterilization/the right choice for each biomaterial:
does sterilization process change the “initial” biocompatibility of a
biomaterial?
- degree of risk.
Infectious risk is dependent on the nature of the tissues with which
the biomaterial will be in contact. There are three levels of risk to be
taken into consideration and three levels of requirements for the
sterilization treatment (see Table 4.1).
Condition of use
Risk
Contact with blood or vascular system or vascularized
tissues
High risk
Contact with mucous membranes or a skin wound
Medium risk
Contact with healthy skin
Low risk
Table 4.1.
Infection risk level of a medical device according to its use
