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Do not use the autoclave in the presence of dangerous gases.
3.5 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
Tuttnauer. Ltd
. company meets the provisions of the following standards:
ISO
9001:2008 (Quality Systems)
Tuttnauer. Ltd.
company also works in conjunction with and refers to:
ANSI/AAMI ST55
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
ISO
17665-1:2006
(Validation and Routine Control)
3.6 Water Quality
3.6.1
Water for Steam Generation
Physical Characteristics and Contaminants Levels
The distilled or mineral–free water supplied to the autoclave should
have the physical characteristics and maximum acceptable level of
contaminants indicated in the table below:
Physical Characteristics and Maximum acceptable contaminants levels
in steam for sterilizers (According to EN 13060: 2010)
Element
Condensate – allowable
content
Silicon dioxide SiO
2
≤0.1 mg/kg
Iron
≤0.1 mg/kg
Cadmium
≤0.005 mg/kg
Lead
≤ 0.05 mg/kg
All other metals except iron, cadmium, lead
≤0.1 mg/kg
Chloride (Cl)
≤0.1 mg/kg
