MELAG DAC Premium Plus - Certificate of Suitability; Product Sterilization Suitability Declaration

Certificate of Suitability
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert Koch Institute
Manufacturer:
MELAG Medizintechnik GmbH & Co. KG
Address:
Geneststraße 6-10
10829 Berlin
Country:
Germany
Product:
DAC Premium Plus
Type of device:
Steam sterilizer
Classification:
Class IIb
Device type acc. to EN 13060:
Type B
We herewith declare that the above designated product is suited for sterilization of
▪ Solid instruments (wrapped and unwrapped)
▪ Porous goods (wrapped and unwrapped)
▪ Products with narrow lumen (wrapped and unwrapped)
▪ Simple hollow items (wrapped and unwrapped)
Instructions on load quantities and loading variants are specified in the user manual
and must be observed.
Be sure to observe the manufacturer’s instructions for medical devices intended for
sterilization according to EN ISO 17664-1.
We herewith declare that the following test system is suited for testing the above cited
steam sterilizer.
▪ MELAcontrol
®
Helix and MELAcontrol
®
Pro
Berlin, 01.08.2023
Dr. Steffen Gebauer
(Management)