MELAG Vacuclave 550 Manual De Uso página 106

Certificate of Suitability
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert Koch Institute.
Manufacturer:
Address:
Country:
Product:
Type of device:
Classification:
Device type acc. to EN 13060:
We herewith declare that the above designated sterilizer is suited for sterilization of
▪ Solid instruments (wrapped and unwrapped)
Porous goods (wrapped and unwrapped)
▪
Instruments with narrow lumen (wrapped and unwrapped)
▪
▪ Simple hollow bodies (wrapped and unwrapped)
Instructions on load quantities and loading variants are set forth 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
▪
Berlin, 07.09.2023
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Vacuclave
Steam sterilizer
Class IIa
Type B
and MELAcontrol
® ®
Dr. Steffen Gebauer
(Management)
® 550
PRO