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3.3
Directives and Standards
Tuttnauer. Ltd
. company meets the provisions of the following standards:
EN ISO
13485:2012 (Quality Systems for Devices)
ISO
9001:2008 (Quality Systems)
MDD
93/42/EEC (Device Directive)
Tuttnauer. Ltd. company also works in conjunction with and refers to:
AAMI/ANSI-ST8
Hospital sterilizers
ASME
American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels
EN 13060
Small Steam Sterilizers
UL
UL 61010-1
PED
97/23EEC
IEC
IEC 61010-2-040 Safety
IEC
IEC 61326-1 EMC
ISO
17665-1:2006 (Validation and Routine Control)
3.4
Electrical Data
Property
Value
Total Power
9000W
Voltage
230VAC / 1ph
Amperage
10A
Protection
against
electrical shock
Class I (IEC 60601-1)
Mains
supply
fluctuation
+/- 10%
Degree of protection
by enclosure
IP31
Note:
In order to avoid any injury by electrical hazard, it is recommended that
a ground fault protection device be installed in the electrical panel
feeding the autoclave (local codes may make this mandatory).
3.5
Environment Emission Information
A.
Peak sound level generated by the sterilizer is « 70 / dBA with a back
sound level of 60 dBA.
B.
Total heat transmitted by the sterilizer is < 150 W/h
