‘International Organization for Standardization’s (ISO) has recently published revisions to all affected parts of ISO 10555 “Intravascular catheters – Sterile and single-use catheters –.”
ISO 10555 now consists of four parts instead of five and among the important changes are the new tests added for balloon dilation catheters and power injection for flow rate and device pressure.
The changes and additions should help catheter manufacturers better understand their products’ performance. The additional guidance on balloon catheters and catheters with pre-connected ports is welcomed as there has been an increase in their use in the field.