C.B.M. S.r.l. a socio unico - Medical Equipment –
Via Castello 10, 26038 Torre dé Picenardi (CR) - Italy
Rev. 06 – 18/02/2019
Manuale SST1700-2200 r06 CE-1282 EN
page 24 of 34
STANDARDS TABLES (EN 13060)
MAXIMUM ADVISABLE LIMITS FOR CONTAMINATING AGENTS AND WATER
SPECIFICATIONS FOR STEAM STERILIZATION
Contaminants of condensate and feed water
Feed water
Condensate
Evaporate residue
≤
10 mg/l
≤
1,0 mg/kg
Silicium Oxide >SiO
2
≤
1 mg/l
≤
0,1 mg/kg
Iron
≤
0,2 mg/l
≤
0,1 mg/kg
Cadmium
≤
0,005 mg/l
≤
0,005 mg/kg
Lead
≤
0,05 mg/l
≤
0,05 mg/kg
Rest of heavy metals, excluding iron,
cadmium, lead
≤
0,1 mg/l
≤
0,1 mg/kg
Chloride
≤
2 mg/l
≤
0,1 mg/kg
Phosphates
≤
0,5 mg/l
≤
0,1 mg/kg
Conductivity at 20°C
≤
15 µS/cm
≤
3 µS/cm
pH Value
From 5 to 7,5
From 5 to 7
Appearance
Colourless, clean, without sediment
Colourless, clean without sediment
Hardness
≤
0,02 mmol/l
≤
0,02 mmol/l
Note1:
The use of water for steam generation with contaminants at levels exceeding those given in this Table
can greatly shorten the working life of a sterilizer and can invalidate the manufacturer’s warranty of guarantee.
Note 2:
The condensate is produced from steam that has been taken from the empty sterilizer chamber.
CYCLES’ COMPLIANCE TO STANDARDS
STERILIZATION CYCLE
Type Test
134/4
standard
B
134/20
prion
B
121/18
delicate
B
134/4
flash
S
Dynamic sterilizer chamber pressure, Air leakage
X
X
X
X
Empty chamber, solid load
X
X
X
X
Small porous items, Small porous load
X
X
X
Full porous load, Multiple wrapping
X
X
X
Narrow lumen (ex Hollow load A)
X
X
X
Simple hollow item (ex Hollow load B)
X
X
X
X
Multiple packaging
X
Dryness, solid load
X
X
X
X
Dryness, porous load
X
X
X
X = Compliant with all applicable points of the UNI EN 13060 Standards
