• IEC/EN/ES 60601-1 3rd Edition for 2 × MOPP
  
   
• Risk Management ISO 14971
  
   
• IPC-A-610 Class 3 High Performance Acceptability
  
   
• EMC Emission to IEC 60601-1-2 ed. 4
  
   
• Quality Management ISO 13485
  
   
• 5-year Warranty

• ISO 9001
  
   
• ISO 14001
  
   
• RoHS
  
   
• REACH
  
   
• EMC Acc. EN 55032
  
   
• ErP Directive

Out of many standards the IPC-A-610 Acceptability of Electronic Assemblies is generally regarded as the most common standard when it comes to what is acceptable with regards to PCB assemblies. It defines 3 classes with different requirements on the assembly process with class 3 being the most demanding of them. To be defined as a class 3 product be build according to variety of criteria which include material qualifications, manufacturing processes and inspection criteria. For an automatic manufacturing process for example this could also mean slowing down the surface mount machines to achieve the required placement accuracy defined in the standard. All requirements have to be met for the power supply to be defined as an IPC-A-610 Class 3 product.

Traco Power’s manufacturing facilities also comply with the ISO 14971 "Application of Risk Management for Medical Devices" standard. This medical specific risk management system defines a management process to ensure all risk are known and acceptable compared to the benefits. Main steps include: defining risks, perform hazard analysis, implement risk mitigation and decide of the acceptability of these risks.

With these two standards in effect Traco Power provides a sophisticated package to not only comply with technical requirements but also makes a commitment to a high quality manufacturing and risk management process to provide the highest grade of medical power supplies possible.