CAN/CSA-ISO 5841.3-97

This National Standard of Canada is equivalent to International Standard ISO 5841-3:1992. 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 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. Nor does it address all aspects of functional compatibility or reliability of different leads and pulse generators assembled into a pacemaker system. WARNING - The connector cavity specified in this part of ISO 5841 is not to be used if the implantable pulse generator is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector (see 4.2.3). 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. NOTE 1 Pacemaker connector assemblies not complying with this part of ISO 5841 may be safe and reliable and may have clinical advantages.