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Page 9 of 56 Pages
2.3
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 304.
Pressure vessel is made of stainless steel 316L.
Cabinet is made of stainless steel 304.
Trays are made of stainless steel 316L.
Generator's vessel is made of carbon steel.
Door closing handle is made of aluminum material, which is safe to
touch and thermo-insulated.
2.4
Environment Emission Information
1.
The peak sound level generated by the autoclave is less than 70 dBa
with background noise of 60 dBa.
2.
The total heat per hour transmitted by the autoclave is < 300 W/h for
all models.
2.5
Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
2.5.1
Technical Directives
1.
Pressure Equipment Directive 97/23/EC.
2.
Council Directive for low voltage equipment 73/23/EEC.
3.
Electromagnetic Compatibility Requirements
Directive
89/336/EC.
2.5.2
Technical Standards
1.
ASME code
2.
IEC-61010-1 & IEC-61010-2-040 - Safety requirements for
medical device.
3.
EN 61326
–
EMC Requirements .
2.5.3
Quality standards
The manufacturing plant meets the following quality standards:
1.
EN ISO 9001:2008
–
Quality System
2.
ISO 13485:2003
–
Quality systems
–
Medical devices.