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2.2 Storage conditions
The packed or unpacked autoclave shall be stored in “indoor
conditions” (protected from rain and water).
2.3 Operating Condition
This device is to be used for indoor use.
This autoclave is intended for NORMAL environment conditions as
follows:
● - Altitude up to 2000m.
● - Minimum room temperature 41ºF (5ºC).
● - Installation Category II.
● - Pollution Degree 2.
The environment shall not exceed an ambient temperature of 40ºC and
a relative humidity of 50% up to a temperature of 31ºC and a humidity
of 80%.
The sterilizer should be loaded only with autoclavable material.
2.4 Standards
2.4.1 Technical standards
1. A.S.M.E. Code, Section VIII div.1 for unfired pressure
vessels.
2. AAMI/ANSI ST-55:2001 Table-Top steam sterilizers.
3. UL61010-1 General Safety.
4. UL61010-2-041 Particular Safety for Autoclaves.
2.4.2 Quality standards
1. EN ISO 9001:2000– Quality System
2. ISO 13485 – Quality systems – Medical devices –
Particular requirements for the application of ISO 9001.
2.5 Construction
The main parts of the autoclave are made of materials as indicated
below:
♦ Chamber is built of stainless steel 316 L.
♦ Door is made of stainless steel CF8.
♦ Trays are made of stainless steel 316.
♦ Door handle is made of hard plastic material that is safe to touch
and thermo-insulated.
♦ Water reservoir is made of hard plastic material.
2.6 Utilities
Utilities Unit Value
V-A 1ph, 120V – 16A,50/60 Hz
Power supply (as appropriate)
V-A 1ph, 230V – 16A,50/60 Hz
Attention:
1. The electrical net must be protected with a current leakage safety
relay.
2. The electrical network must comply with local rules or regulations.
3. The autoclave must be connected to a properly grounded outlet
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