Spotting the new standards in medical devices is not an easy task as they are not identified as new in the list of all electrical standards included in the Medical Devices Directive
Companies involved in this sector need to keep a permanent eye on the list to check if any changes have occurred.
New standards for the EU Medical Devices Directive (MDD), 93/42/EC:.
Medical electrical equipment: EN 60601-1-6.
This wholly new part-standard concerns safety and covers usability.
The previous standard for electrocardiographic monitoring equipment has been upgraded: EN 60601-2-27.
A new amendment was made (A2: 2005) to the already existing standard on the safety of ultrasonic medical diagnostic and monitoring equipment: EN 60601-2-37.
Global harmonisation task force (GHTF) meeting.
After a break of four years, representatives of the major regulatory systems in the medical sector throughout the world met to discuss the creation of a common basis of technical specifications, of evaluation and test procedures and of supplier monitoring.
Thus the efforts to create global harmonisation in medical equipment standards have been revived with hopes for real progresses in the near future.
