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

Conformity

STERILIZER featuring sterilization cycles conform with the following
standards:
Standards
and Description
Directives
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.
93/42/EEC
Pressure Equipment Directive (PED).
Directive 2014/68/EU (PED – Pressure Equipment Directive) for
every sterilization chamber designed and manufactured in
2014/68/EU
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 sterilizer.
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
IEC 61010- Safety requirements for electrical equipment for measurement,
2-040 control and laboratory use; particular requirements for autoclaves
using steam for the treatment of medical materials and for
laboratory processes.
IEC 61326-1 Electrical equipment for measurement, control and laboratory use:
EMC requirements.
IEC 61770 Back syphonage.
LISA | Instructions for use | VA131 ENG Rev. 05 | 31/07/2018 | © 2018 W&H Sterilization Srl
Note: See the Declaration of Conformity and the Warranty Card in the
enclosed documents.
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