Active implantable medical devices – Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
|Publication Date:||1 January 2011|
This Technical Information Report provides guidance for the color coding and marking of IS-1, DF-1, IS4, and DF4 connectors to reduce the potential for lead-to-pulse generator connection errors during implant surgery.
This document provides the following:
a) a standardized color scheme for DF-1 lead connectors
b) visual distinction of leads intended for left ventricular (LV) placement
c) color distinction between IS4 and DF4 lead connectors
d) a recommendation for lead length marking to help distinguish between pacing leads placed in the right ventricle (RV) and right atrium (RA)
e) guidance for standardizing connector nomenclature
This document is based on common systems that use current standards such as ISO 5841-3, ISO 11318, and ISO 27186. It does not apply to unique device headers or leads, nor does it apply to sensors. It also does not cover all applications for color coding, particularly those that existed before the drafting of this document or that might be used by individual manufacturers for specific reasons.