Delta Electronics has achieved a breakthrough in the power-supply sector – a high voltage generator for X-ray equipment, which recently received medical device certification by TÜV Rheinland. Achieving compliance with the European Union (EU) MDD 93/42/EEC medical devices directive, and receiving EN ISO 13485 medical quality management system certification is an industry milestone that makes Delta the first power-supply manufacturer in Taiwan capable of manufacturing medical-grade high-voltage generators for X-ray equipment.
High-voltage generators for X-ray equipment are required to provide consistent, high-voltage, high-current output and meet stringent radiation, stability and reliability criteria. To meet these demanding requirements, TÜV Rheinland engaged a team of medical device experts from Taiwan, Japan and China to carry out the assessment and certification process based on the EU’s harmonized standards and regulations.
Exhibitor: TÜV Rheinland