Scope Of Delivery - Thermo Scientific VARIOKLAV 25T Operating Manual

All VARIOKLAV steam sterilizers are CE-marked based on the European
Pressure Equipment Directive 97/23/EC and the Low-Voltage Directive as well as
the EMC Directive.
Since January 1
compatibility (EMC) has been in force and binding for all units with electrical or
electronic components. It requires adequate resistance to jamming and limited
emitted disturbance radiation of units operated electrically or electronically. Units
must be CE-marked.
The electrical control system for VARIOKLAV steam sterilizers is designed as a
low voltage system; the heating system operates with 230 V. They are therefore
covered by the Council Low-Voltage Directive
have to be CE-marked in accordance with this Directive (and with its amendment
93/68/EEC).
As the VARIOKLAV steam sterilizers are not machinery
Machinery Directive 89/392/EEC (pressure vessels being explicitly excluded from
its scope), they cannot be CE-marked in accordance with this Directive.
Furthermore, the EU Medical Products Guideline has been in effect since January
st
1 , 1995, and the transition period stipulated in the Guideline ended on June 14
1998. This Guideline, however, is relevant only for those steam sterilizers that are
used for sterilizing medical devices.
The following operating documents are supplied with the delivery (as invoiced):
•
•
The unit comes with the following documentation:
•
•
•

10.1 Scope of delivery

In addition to the documents already mentioned, a 1 m silicon hose with connector
is included with the sterilizer. This hose is used for emptying the feed water tank.
(See Checklist for Routine Care and Maintenance.)
8)
Excerpt from the Council Directive "Electrical equipment designed for use within certain voltage
limits" 73/23/EEC:
Article 1
For the purposes of this Directive, "electrical equipment" means any equipment designed for use with a
voltage rating of between 50 and 1000 V for alternating current (...).
9)
Excerpt from the Council Directive "Machinery" 89/392/EEC:
Article 1
(...)
(2) For the purposes of this directive, "machinery" means an assembly of linked parts or components, at
least one of which moves, with the appropriate actuators, control and power circuits, etc., joined
together for a specific application, in particular for the processing, treatment, moving or packaging of a
material.
The term "machinery" also covers an assembly of machines which, in order to achieve the same end,
are arranged and controlled so that they function as an integral whole.
(3) The following are excluded from the scope of this Directive: (...)
(...)
steam boilers, tanks and pressure vessels,
(...)
03/2007
10 Initial commissioning
st
, 1996, the Council Directive 89/336/EEC on electromagnetic
Declaration of Conformity for the unit pursuant to the Pressure
Equipment Directive DGRL 97/23/EC.
Certificate for the thermal safety system to prevent retarded boiling
(Thermolock according to TRB 402)
Operating Manual with commissioning, maintenance and care
instructions
Short Operating Manual
Checklist for Routine Care and Maintenance
8))
. Since January 2
9))
as defined by the
43
nd
, 1997, units
th
,
DA0621_a/