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4 Putting the sterilizer into service
Free movement pursuant to European Pressure Equipment Directive
97/23/EC
Since May 30, 2002, the VARIOKLAV Type 65 T steam sterilizer is manufactured
pursuant to the Pressure Equipment Directive PED 97/23/EC. Pursuant to Section
9 of the PED 97/23/EC, the device is classed as Category I. It is also tested
according to the conformity evaluation process as described in Section 10 of the
PED 97/23/EC Module A.
This means that the conditions for placing pressure equipment on the market or
putting them into service pursuant to the Pressure Equipment Directive PED
97/23/EC Section 4 (1) 1.1.
According to this regulation, the sterilizer can be deployed in Europe without
exception while not requiring approval by official bodies.
According to the European Guideline concerning Medical Devices 93/42/EEC,
the VARIOKLAV Type 65 TC steam sterilizer must, however, be validated pursuant
to DIN 554 (1994).
For the operation of the VARIOKLAV Type 65 TC steam sterilizer the national
regulations have to be met.
4.5
Installation site
CAUTION
Do not deploy the unit in the direct vicinity of a fire alarm.
Exiting steam could set off the fire alarm.
♦ Choose a stable and level area for deploying the sterilizer (e.g. a table,
workbench or, optionally, a base). It should be capable of supporting a
weight of 250 kg
the feet of the unit. Place the unit in its intended location.
The feet of the unit have been adjusted to different heights in order to get
the device up to 5 mm lower in the back than in the front.
This backward inclination allows any condensate to collect at the bottom back so
that it can be removed via the floor valve.
♦ When installing the sterilizer, keep a distance of at least 100 mm from the
wall and from other devices on all sides. The unit must be freely
accessible in the area of the sterile filter access and from above.
♦ Install the rack system in the sterilizing chamber (9), if you do not intend
to use sterilization containers but wish to use up to 8 steel wire baskets.
5)
Excerpt from the Pressure Equipment Directive PED 97/23/EC
Section 4 Free Movement
(1) 1.1 Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede
the placing on the market or putting into service under the conditions specified by the manufacturer of
pressure equipment or assemblies referred to in Section 1 which comply with this Directive and bear the
CE marking indicating that they have undergone conformity assessment in accordance with Section 10.
6)
The weight when performing on-site water pressure tests for pressure vessels or steam boilers for
repeat testing is also 250 kg.
Thermo Scientific
5)
are met.
6)
. Note that massive support is required in the vicinity of
23
50112712_082007_GB
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