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Astell Autoclaves/Sterilisers – AMB220 | AMB230 | AMB240 | AMB420 | AMB430 | AMB440 | AMA240 | AMA440
LEGAL AND SAFETY REGULATIONS AND
REQUIREMENTS
* (INTERNATIONALLY HARMONISED) standard 61010-1-1-ISSUE 3 section 5.4.101.1 and Pressure Equipment Directive. P.E.D
Pressure Equipment
Directive
(European models)
Please note that this equipment is covered by the European Pressure Equipment
Directive. This may already affect your premises and you will need to ensure that
the machine is included in any scheme covered by these regulations.
(USA models are manufactured to the European directive)
Periodic inspection and
safety valve test
The manufacturer recommends every 4 to 12 weeks carrying out the periodic
maintenance checks of the machine and the closure system (door) as explained in
this manual.
At intervals of 3-months carry out the safety valve test, as explained in this manual.
If this test is missed the screen will display a warning that the safety valve test is
overdue. To clear the warning you must carry out a safety valve test.
Log book
A log-book or similar record should be kept for each steriliser.
This should record the results of
• Commissioning and calibration
• Safety valve tests
• Annual and insurance inspections
• Faults and malfunctions
• Service visits
• Other actions or incidents
Check the logbook before you start using the machine, as someone else may have
recorded a problem or fault of which you are not aware.
Responsible person
This equipment stores considerable thermal energy and could be hazardous if not
used and maintained correctly.
European models:
European regulations* require that a responsible person should be appointed who
will be in charge of the maintenance, safety, and operation of the steriliser and for
user training.
United States and Canada:
All local requirements for pressure vessels must be complied with.
Training
It is the duty of the responsible person to ensure that all persons who operator
or maintain the equipment have been trained in the correct and safe operation
of the steriliser, including emergency procedures and what to do in the case of
malfunction.
The responsible person must ensure that all persons carrying out maintenance on
the working parts of the steriliser are fully familiar with operation of the machine
and suitably qualified for work on pressurised steam and safety related systems.
This training should be regularly repeated and formally recorded in an appropriate
training schedule and records of attendance of persons at training sessions should
be included.
Training should be organized and monitored so that evidence of understanding is
demonstrated by the trainee.