It is our standard to oversize the highest international safety standards
All our systems have the following qualifications:
- EN ISO 13485 medical devices and quality management system requirements
- Guideline 93/42/EWG Anhang V
- EN ISO 15883 cleaning and disinfection equipment
- VDE 0100-701 Errichten von Niederspannungsanlagen (development of low voltage systems) – part 7-0701
- All our systems are qualified as – medical devices class IIa (CE 0197)
Quality Standards
All our systems have the following qualifications:
