MELAG Vacuklav 41 B+ - Page 4

Certificate of Suitability
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert-Koch Institute (Year 2012)
Manufacturer:
MELAG Medizintechnik oHG
Address:
Geneststraße 6-10
10829 Berlin
Country:
Germany
Product:
Vacuklav
®
41 B+/Vacuklav
®
43 B+
Type of device:
Steam sterilizer (steam sterilizer)
Classification:
Class 2b
Device type acc. to DIN EN
13060:
Type B
We herewith declare that the above designated sterilizer is suited for sterilization of
▪ Solid instruments (wrapped and unwrapped)
▪ Porous goods (wrapped and unwrapped)
▪ Hollow bodies Type A (wrapped and unwrapped)
▪ Hollow bodies Type B (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 DIN EN ISO 17664.
We herewith declare that the following test system is suited for testing the above cited
steam sterilizer.
▪ Helix-Test body according to DIN EN 867-5:
MELAcontrol
®
and MELAcontrol
®
PRO
Berlin, September 08, 2014
Dr. Steffen Gebauer
(General Management)