Requirements of he
Requirements of heart prosthesis
requirements specified for implants with regard to duration of contact with human. Body where the contact medium and the intended biostability of the material are stricter compatibility than those for operating. Theatre textiles and products which are used in direct contact with the central nervous system or in the immediate vicinity of the heart or those which are deliberately dissolved in the body .
The most important general requirement of heart prosthesis is
The compatibility of the material to the human body and the ease with it can be sterilized .
1- no triggering of immunological reactions and allergies
2- no causing of unusual foreign body reaction
3- no cytotoxic reaction .
4- no mutagenic, teratogenic or earunogenic reaction
5- no undesirable biodegradation
6- blood compatibility – no change in blood composition and blood properties ( blood clothing haemolysis)
7- wide – lumen textile vascular replacement a cement thrombogenic for intraco - operative sealing
9- freedom from pyrogens
10- adequate stability of the structure ( including under long – term loading - tensile- pressure- bending)
11- load- elongation characteristics compatible with the tissue being replaced
12- inter operative length matching of the prosthesis
13- availability in suitable dimensions .