This standard 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 standard. This standard 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.
The connector cavity specified in this part is not applicable if the implantable pulse generator is capable of introducing dangerous nonpacing signals (e.g. defibrillation signals) through an IS-1 connector (see 4.3.3).
This standard supplements GB 16174.1 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 requirements in GB 16174.1.
Note: Pacemaker connector assemblies not complying with this standard may be safe and reliable and may have clinical advantages.
Contents 1 Scope 2 Normative References 3 Terms and definitions 4 Requirements Appendix A (Normative) Lead Connector Electrical Impedance Test Method Appendix B (Informative) Rationale
1 Scope
This standard 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 standard. This standard 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.
The connector cavity specified in this part is not applicable if the implantable pulse generator is capable of introducing dangerous nonpacing signals (e.g. defibrillation signals) through an IS-1 connector (see 4.3.3).
This standard supplements GB 16174.1 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 requirements in GB 16174.1.
Note: Pacemaker connector assemblies not complying with this standard may be safe and reliable and may have clinical advantages.
Contents of YY/T 0491-2004
Contents
1 Scope
2 Normative References
3 Terms and definitions
4 Requirements
Appendix A (Normative) Lead Connector Electrical Impedance Test Method
Appendix B (Informative) Rationale
