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ISO 5841-3 3rd Edition, April 15, 2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
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Availability date: 07/13/2021
Description / Abstract:
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 labeling to be
fitted with and 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.