Page 12 of 85 Pages
3.7.3
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.
3.8
Electrical Data
Model
Power
consumption
Supply Voltage
Line
current
Protection against
electrical shock
5075
6 x 1100W
3 Ph, 400V/50Hz
11A
Class I
(IEC 60601-1)
5050
4 x 1100W
3 Ph, 400V/50Hz
11A
Class I
(IEC 60601-1)
Содержание 5050
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