Labfors 5 – Version for Microorganisms
Safety and Responsibility
22 January 2019
Page
13
of
205
For use for special applications not covered by conventional, in-
tended use, the equipment must be modified and certified accord-
ingly by the manufacturer.
Any use of the equipment outside of a biotechnology laboratory,
i.e. in any environment in which the conditions required for the
safety of the users cannot be fulfilled or cannot be fulfilled to their
full extent, shall also be deemed misuse.
2.2 Qualified Personnel
Due to the complexity of the equipment and the potential risks aris-
ing from its operation, the equipment may only be used by quali-
fied, specialist personnel.
2.2.1 Provider
The term “provider” applies to all persons who are responsible for
making the equipment and the necessary infrastructure available.
These persons may also be included in the group of people known
as “users”, though this is not always the case.
Irrespective of whether a provider is a member of the company’s
board of management or a supervisor, they bear a special level of
responsibility with regard to the processes and the qualification and
safety of the users.
2.2.2 User
General
The term “user” applies to all persons who come into contact with
the equipment in any way and perform work on or with it. This pri-
marily applies to the following activities, which can be performed by
the manufacturer’s own specialists or a variety of other persons (it
is not always possible to distinguish clearly between the different
types of person):
Assembly, installation and commissioning
Definition and preparation of the process
Operation
Troubleshooting and remedying of faults
Maintenance and cleaning (autoclaving, if necessary)
Service work and repairs
Disassembly, disposal and recycling
Summary of Contents for Labfors 5
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