Tuttnauer LABSCI 15, Руководство по эксплуатации и обслуживанию

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Page 15
3.5 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with 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)
3.6 Water Quality
The distilled or mineral-free water supply shall be according to the table
below:
Physical Characteristics and Maximum acceptable contaminants levels
in water or steam, for steam generator and sterilizers
Contaminants in
water supplied to
generator/chamber
Contaminants in
condensate at steam
inlet to sterilizer
Evaporate residue
≤ 10 mg/l
N/A
Silicate (SiO
2
)
≤ 1 mg/l ≤ 0.1 mg/l
Iron
≤ 0.2mg/l ≤ 0.1mg/l
Cadmium
≤ 0.005 mg/l ≤ 0.005 mg/l
Lead
≤ 0.05 mg/l ≤ 0.05 mg/l
Rest of heavy metals
except iron,
cadmium, lead
≤ 0.1 mg/l ≤ 0.1 mg/l
Chloride (Cl)
≤ 2 mg/l ≤ 0.1 mg/l