MN-111 | Instructions for Use | MN-111 W&H Med ENG Rev12 | 2019/08/31 | © 2019 W&H Sterilization Srl
5
Conformity
CONFORMITY TO EUROPEAN AND AMERICAN STANDARDS AND
DIRECTIVES
STERILIZER featuring sterilization cycles conform with the following
standards:
Standards
and
Directives
Description
93/42/EEC
Medical Device Directive (MDD).
Medical Device Directive 93/42/EEC for devices class IIb, in
accordance with the Rule 15 – ANNEX IX of the above Directive.
2014/68/EU
Pressure Equipment Directive (PED).
Directive 2014/68/EU (PED – Pressure Equipment Directive) for
every sterilization chamber designed and manufactured in
conformity to the ANNEX 1 and to the procedure described in the
module D1 Annex III.
2012/19/EU
Waste Electrical and Electronic Equipment (WEEE).
CSA C22.2
No. 61010-
1-12
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
UL 61010-
1:2012
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
ASME
Boiler and pressure vessel code.
EN 13060
Small steam sterilizers.
ANSI/AAMI
ST55:2010
Table-top steam sterilizers.
Standards
and
Directives
Description
IEC 61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
IEC 61010-
2-040
Safety requirements for electrical equipment for measurement,
control and laboratory use; particular requirements for sterilizers and
washer-disinfectors used to treat medical materials.
IEC 61326-1
Electrical equipment for measurement, control and laboratory use -
EMC requirements; general requirements.
IEC 61770
Electric appliances connected to the water mains - Avoidance of
backsiphonage and failure of hose-sets.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.
Summary of Contents for Lexa MN-111
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