Amendment to 60601-1 Underscores Role of Safety in Device Design

For those who design, manufacture, or test electromedical equipment, 60601-1 is one of the most important safety and performance standards in AAMI’s portfolio of industry standards. It is referenced so often in the daily work of medical device engineers that AAMI plans to offer this updated standard in a pocket version.

60601-1 deals with medical devices that are intended to: 1) diagnose, treat, or monitor a patient under medical supervision; 2) make physical or electrical contact with the patient; 3) transfer energy to or from the patient; and/or 4) detect such energy transfer to or from the patient. Examples include battery-operated thermometers, external defibrillators, MRI and other imaging systems, endoscopes, patient monitors, and infusion pumps.

Read full article at AAMI News.