W&H Lisa VA131-17, Instructions For Use Manual

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Conformity
LISA | Instructions for Use | VA131 2019 ENG Rev06 | 16/04/2020 | © 2020 W&H Sterilization Srl 5
CONFORMITY TO EUROPEAN 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).
EN 13060 Small steam sterilizers.
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: LISA sterilizers can be validated in accordance to EN17665-1.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.