Medical Device Qualified Supplier Directory
Qualifications: Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Worldwide
• Medical AC/DC Power Supplies, 5~450 Watts
• Medical DC/DC Converters, 2~30 Watts
TRACO POWER North America is a wholly owned subsidiary of TRACO Electronic AG, a Swiss company with headquarters in Baar, Switzerland. TRACO markets its products worldwide under the registered trademark TRACO POWER. As a leading power supply specialist with more than 35 years’ experience we are dedicated to the design and manufacturing of high quality DC/DC and AC/DC power conversion products with an emphasis in medical approved solutions.
SAFETY APPROVALS, COMPLIANCE and QUALITY MANAGEMENT
TRACO POWER products are suitable for B and BF rated equipment. Our safety critical products are globally certified to current Medical regulations and standards and approved to the requirements for applied parts applications with a 2xMOPP rating and are BF compliant. TRACO POWERS's global manufacturing facilities are certified to ISO 9001/14000. Our commitment to quality is supported by a full 5 year warranty on our Medical products.
All products have fully regulated output voltages, a reinforced insulation system, low leakage current and feature:
• Product certification according to IEC/EN/ES 60601-1 3rd edition for 2xMOPP
• IEC 60601-1-2 4th Edition Compliance for EMC (required April 2017)
• Risk management process according to ISO 14971 including risk management file
• Acceptance criteria for electronic assemblies according to IPC-A-610 Level 3
• Design and production to ISO 13485 quality management system (certification soon)
• 5-year product warranty
ENGINEERING SUPPORT / GLOBAL SALES & AVAILABILITY / SUSTAINABILITY
To support direct customers and our distribution channels, TRACO POWER has established sales and technical support centers in key locations, including:
• North America - Northern California & Massachusetts
• Europe - Switzerland & Germany
TRACO POWER distributes its products through a global network of franchised distributors recognized in the industry for top- level design, stocking and supply chain services. The majority of products presented in our selection guide and on our web site are available ex-stock for dispatch from our central warehouse in Baar, Switzerland within 48 hours. With an extended product lifecycle, TRACO POWER provides for long-term disposability and maintenance.
For more information contact TRACO POWER North America, Inc.
TPP 100A-J and TPP 150A-J series
• IEC/EN/UL 609501 Approvals (ITE)• IEC/EN/ES 60601-1 3rd Edition Approvals (Medical)• EMC compliance to EN55011 & IEC60601-1-2 4th Edition• Risk Management file Per ISO 14971• 12V Aux Fan Output (150W models)• Max 0.3W No Load power consumption (ErP Ready)• Optional Enclosed Models (see below)• 5 Year Wa...