Implants for surgery – malleable cables for use as sutures and other surgical applications.
This International Standard specifies the dimensions and mechanical properties of malleable wires for use as sutures and other forms of tissue and implant fixation in surgery and provides test methods. The specified mechanical properties are tensile strength, elongation and resistance to damage in bending and twisting.
For such surgical applications, it is essential that the wire can be twisted or knotted without fracturing or developing cracks or crevices on its surface.
2 Malleable cables can be used in close connection with other implants. In these circumstances, it is important that the stainless steel wire of the compositions D and Ε (see ISO 5832-1) is only used in connection with the implants made of corresponding stainless steel, and the wires made of stainless steel with high content of Nitrogen should only be used in connection with stainless steel implants with high nitrogen content. This will reduce the possibility of galvanic corrosion occurring between the cables and the implant.