This part of ISO 5841 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods.
Other connector features such as fastening means and materials are not specified in this part of ISO 5841. This part of ISO 5841 is applicable only to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance or reliability of different leads and pulse generators assemblies.
This part of ISO 5841 supplements ISO 5841-1 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 ISO 5841-1.
Pacemaker connector assemblies not complying with this part of ISO 5841 may be safe and reliable and may have clinical advantages.