Operator's Obligations; Safety Tests And Inspections Carried Out By The Manufacturer At The Facilities - Sartorius Stedim Biotech Sartocheck 4 plus Betriebsanleitung

3.4 Operator's Obligations

3.5 Safety Tests and Inspections
Carried Out by the
Manufacturer at the Facilities
12 Safety
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Definitions Adapted from EN 60204-1:
Trained Worker
A person familiarized with and, if applicable, trained in their particular duties by
a qualified technician and instructed about the potential dangers in the event of
improper conduct and on the necessary safety devices and safety precautions.
Qualified Technician
A person who, by virtue of their technical training, know-how, experience and
knowledge of relevant standards, is able to assess the work assigned to them
and identify potential dangers.
In the European Economic Area (EEA), the laws to nationally implement Council
Directive (89/391/EEC), as well as the corresponding individual Directives and specifi-
cally including Council Directive (89/655/EEC) concerning the minimum safety and
health requirements for the use of work equipment by workers during labor, must be
observed and complied with in their respectively valid versions.
In Germany, the Operational Safety Regulation dated October 2002 must be
observed (regulation transposing the above-mentioned Directives into national law).
The operator must obtain a local operating permit and follow the regulations and
restrictions set forth therein.
Additionally, the operator must comply with the local rules and
regulations for:
– The safety of the personnel (accident prevention regulations)
– The safety of the work equipment (protective gear and equipment and
maintenance)
– Product disposal (Waste Management Act)
– Material disposal (Waste Management Act)
– Cleaning (cleaning agents and disposal) and the environmental rules
and regulations.
1. Measurement of airborne noise
2. Testing and inspection according to DIN EN 61010-1
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