Traco Power offers a broad range of trusted medical supplies to power medical equipment where it matters, covering non-applied as well as applied system devices.
For non-applied parts sections of medical equipment, power and safety requirements can be satisfied by any of Traco Power’s power supplies: non-medical for 1 x MOPP (means of patient protection) applications and medical rated power supplies for all other MOPP levels. If this part of the system is attaching to a DC input from a non-medical rated power supply, then use of Traco’s DC/DC converters should satisfy safety requirements for 1 x MOPP/2 x MOPP applications.
For applied parts sections of medical equipment, sufficient clearance and creepage distances, as well as a secondary isolation barrier, are required to further isolate the patient from potentially high voltages. The isolation barrier may be satisfied using Traco Power’s medical rated 2 x MOPP AC/DC power supplies or DC/DC converters.
Even this reinforced insulation system does not unconditionally qualify a power supply unit and DC/DC converter for medical applications. Particular and collateral standards also require that a risk/quality management system be in place at the component level, especially for safety critical applications.
Traco Power products for applied parts applications with a 2 x MOPP rating have been carefully designed and manufactured to the highest standards to meet the increased quality, reliability and safety standards for medical equipment. These products have fully regulated output voltages as well as the following features:
• Product certification according to IEC/EN/ES 60601-1 3rd edition for 2 x MOPP.
• Risk management process according to ISO 14971 including risk management file.
• EMC emission and immunity according to IEC 60601-1-2 edition 4.
• Acceptance criteria for electronic assemblies according to IPC-A-610 Level 3.
• Design and production according to the ISO 13485 quality management system.
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