SRPS EN 50077:2012

Low-profile connector for implantable cardiac pacemakers

Scope

This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction. WARNING The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector. This European standard supplements EN 50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN 50061 regarding leads.