Risk Assessment for Power Supplies to Comply with IEC 60601-1 3rd Edition

  • Magazine Article
  • TBMG-15537
Published January 01, 2013 by Tech Briefs Media Group in United States
Language:
  • English

For medical device OEMs seeking compliance to the 3rd Edition of IEC 60601-1 for their power supplies, what is quite clear by now are the regional dates for enforcement, the required risk management at the medical electrical equipment or system level, the new definitions of Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP), and other differences as compared to the 2nd Edition. What is not clear is how to address these new definitions and requirements. Rather than simply redesigning and resubmitting for 3rd Edition certification, questionnaires and flowcharts that map out the requirements at the device or system level help to minimize the evaluation and redesign at the power supply level. By having the medical device OEM and power supply vendor answer the questionnaire concurrently, deficiencies from the equipment or power supply can be quickly assessed in order to satisfy the requirement.