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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 declare that the product specified above is suitable for the steam 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)
References to loading quantities and loading variations are outlined 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.
We declare that the following test system is suited for testing the product specified
above:
▪
Helix test body according to EN 867-5:
MELAcontrol
Berlin, 01.02.2023
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Vacuclave
Steam sterilizer
Class IIa
Type B
®
®
and MELAcontrol
Dr. Steffen Gebauer
(Management)
®
®
318/Vacuclave
323
PRO
Publicidad
