Professional Documents
Culture Documents
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Distribution
system
Terminal units
Area
control
units
Alarms
Plant alarm
Vacuum plant
Cylinder manifolds
Air plant
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Liquid Oxygen
Standards
No Law
Defining the state of the art
In a trial case, reference will be made to the state of the art !
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EN 7396-1
Common Requirements and
Safety Standards
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DIN
BS
French
Others
German
Standard
British Standard
HTM 02-01
Air Liquide
System
C11
AFNOR
AGA
Dutch
etc.
EN 7396-1
Common Requirements and
Safety Standards
BS
French
Others
British Standard
HTM 02-01
C11
Air Liquide
System
AGA
Dutch
etc.
DIN
German
Standard
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ISO 7396-1
Common Requirements and
Safety Standards
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Europe
US
EN 7396-1
NFPA 99
Japanese
Others
Rest
of the
World.
French System
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German System
French System
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German System
Uninterrupted (24/7)
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1 source is in maintenance
Possible combinations:
a) 3 compressors
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To Terminal Units
AutoChangeover
O2
Emergency Inlet
Point
Liquid Gas
Pressure
Reducer
e.g. 18 bar
Filter
Evaporator
Main Supply
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Emergency Supply
Valve
Feeding Point
NIST
Alarm Sensor
Gauge
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Uninterrupted (24/7)
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Central Monitoring
Clinical emergency signals
Alarm Management System, R. Harm, 26.02.2009
Operation signals
Local displays
Uninterrupted (24/7)
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Contamination
Carbon dioxide
500 ml / m
Carbon monoxide
5 ml / m
Oil
Sulphur dioxide
1 ml / m
Nitric oxide
2 ml / m
Nitrogen dioxide
2 ml / m
Oxygen
Water
Pre-filter - 0,01
oil- , water aerosols , solid particles
Dust filter
dust
2
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Soldering
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Uninterrupted (24/7)
Resposibility of Pharmacist
Supervision of status and function by an Alarm
Management System
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GDS
Interface
Building Management
SMS / e-mail
Laptop/iPad/iPhone...
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The conformity assessment shall proof that the individual Gas Management
System:
-
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System
Components
Compressors, Manifolds, Valves
For each component a risk analysis
has to be done. Only proven products
shall be used.
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and the
(Full Quality Assurance System, Annex II, section 3
of the Directive 93 / 42 / EEC on Medical Devices)
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For the proper installation of the Gas Management System (on site
production) a released Installation Manual has to be followed.
The Drger processes DMS OG/OF9000 ff. ensure that all requirements are
fulfilled.
Quality documentation for the complete product / project shall be carried out
according DMS OF9000 A6.
Controlled Documents
System Catalog GMS
released Components
Design Guidelines
Documentation
per Project
DMS OF9000 A6
Installation Manual
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Business License
EC-Certificate
Drger Medical GmbH
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