1 Scope
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
generator assemblies.
This part of ISO 5841 supplements ISO 14708-2 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 requirements in ISO 14708-2.
NOTE Pacemaker connector assemblies not complying with this part of ISO 5841 may be safe and reliable and may have clinical advantages.