MAN205-0195042EN Rev. A Aug. 2011
Page 9 of 137 pages
1.3 Standards
Tuttnauer. Ltd. company meets the provisions of the Medical Device Directive
93/42EEC and PED 97/23EEC and the following standards:
ASME American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels.
AAMI/ANSI-ST8 Hospital sterilizers
EN 285 Large Sterilizers.
EN 554 Validation and routine control.
UL UL 61010-1
IEC IEC 61010-2-040 Safety
Tuttnauer. Ltd. is also approved for:
ISO 9001:2008 (Quality Systems)
ISO 13485:2003 (Quality Systems for Medical Devices)
ISO 17665-1:2006 (Validation and Routine Control)
1.4 Specifications
Tap Water supply
Maximum hardness value 0.7-2.0 mmol/l
Recommended temperature 15°C (60°F)
1. Connection: ½" thread
2. Pressure: 2–5 bar (30–70 psi)
1. Connection: ¾" thread
2. Pressure: 3.5–4.5 bar (60–65 psi)
Distilled or Mineral free water
1. Connection: ½" thread
2. Pressure: 2–5 bar (30–70 psi)
See chapter "Water Quality"
Compressed air requirements
1. Connection: ¼" thread
2. Pressure: 6–8 bar (85–115 psi)
3. Consumption: 100 LPM
Electrical cable requirements