International Organization for Standardization (ISO)
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ISO 5841-3:2013
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 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 NOTE Pacemaker connector assemblies not complying with this part of ISO 5841 may be safe and reliable and may have clinical advantages.
ISO 5841-3:2013 Referenced Document
ISO 14708-2 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers*, 2019-09-03 Update
ISO 5841-3:2013 history
2013ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
2003ISO 5841-3:2000/Cor 1:2003 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers; Technical Corrigendum 1
2000ISO 5841-3:2000 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-1] for implantable pacemakers
1992ISO 5841-3:1992 Cardiac pacemakers; part 3: low-profile connectors (IS-1) for implantable pacemakers