Therapy possibilities

Our products and our business are subject to the most scrupulous ISO 13485 quality checks. Both have been certified in accordance with the strict guidelines for medical devices. We have CE marking and operate in accordance with EU guidelines 93/42/EWG. Our work is supervised by the Swiss accreditation body and is therefore directly affiliated to the European Accreditation System:
– ISO 13485 + 14971
– CE (Europa) 93/42/CEE
– CB (Internazionale) IEC-EN 60601
– ETL (USA/ Canada) UL 60601

TinniTool laser meets requirements as per:
– IEC 60601-1 = Medical electrical equipment: General requirements for safety
– IEC 60601-1-2 = Medical electrical equipment: General specifications for safety
– IEC 60601-1-6 = Medical electrical equipment: General requirements for basic safety and essential performance – Col-lateral standard: Usability
– IEC 60601-1-11 = Medical electrical equipment: General requirements for basic safety and essential performance
– IEC 60825-1 = Safety of laser devices: classification of facilities and requirements
– IEC 62366 = Medical devices – Application of usability engineering to medical devices
– IEC 980 = Graphical symbols for labeling of medical devices
– Risk analysis in accordance with DIN-EN-1441 and EN-ISO-14971