Pacemaker leads are insulated wires that deliver electrical pulses as needed to bring the heart back to a normal rhythm. Our cardiovascular device testing experts understand how crucial it is that these devices perform as intended to keep patients safe and improve their quality of life.

Pacemaker leads and advances in cardiac pacing are part of the foundation for the development ofneurostimulator leadsand neuromodulation therapies. Stimulator lead designs play a critical role in the emergence of these therapies and require extensive testing.

Pacemaker and defibrillator lead testing

Pacemaker lead testing allows manufacturers to understand how their device design meets industry standards and guidelines. Our experts evaluate pacemaker leads to collect data that assures the device is safe and effective before being introduced to the market.

电气和机械测试是在组件,子组件或成品引线上进行的。我们在模拟体内条件下的环境中进行起搏器铅测试。

Our pacemaker lead testing includes:

  • Electrical continuity verification of each conduction path
  • Leakage current measurement during voltage application (after soaking, before drying)
  • Measurement of the strength of each bond, joint, etc. in the lead, as well as the composite lead strength
  • Measurement of the stylet insertion and removal forces
  • Fatigue resistance of the conductor(s) and lead transition zones
  • Mechanical loading that mimics forces that might occur after implantation on connectors intended for joining pulse generators and leads
  • 评价锚固套管用铅包装的性能
  • Measurement of the pressure exerted by lead tip
  • Quantification of the number of revolutions required to extend and retract the helix of active fixation leads

For more information about our neurostimulator or pacemaker lead testing services,contact ustoday.

pacemaker lead testing

Standards we test to

British Standards Institution

  • BS EN 45502-2-2

International Electrotechnical Commission

  • IEC 60601-1, IEC 60601-2-10, IEC 62353

国际标准化组织

  • ISO 5841-3, ISO 14708-1, ISO 14708-2, ISO 14708-3

The FDA Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions outlines many of the recommended tests for cardiac leads.

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