Conformity - W&H Lexa PLUS Instructions For Use Manual

Conformity

CONFORMITY TO EUROPEAN AND AMERICAN REGULATIONS,
STANDARDS AND DIRECTIVES
Sterilizer conforms with the following Regulations, Standards and
Directives:
Standards
and Description
Directives
Medical Device Regulation (MDR).
Regulation (UE) n. 2017/745 for medical devices. Class IIb
devices, in accordance with the Rule 16 – ANNEX VIII of the above
Regulation.
For Device in compliance with Machinery Directive (2006/42/EC),
Low Voltage Directive (2014/35/EU) and Electomagnetic
Compatibility Directive (2014/30/EU).
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 Directive (WEEE).
Safety requirements for electrical equipment for measurement,
CSA C22.2 No.
61010-1 control and laboratory use, general requirements.
UL 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Lexa PLUS | Instructions for Use | RIS-311 ENG Rev03 | 29/08/2022 | © W&H Sterilization Srl
Standards
and Description
Directives
Boiler and pressure vessel code.
ASME
EN 13060 Small steam sterilizers.
ANSI/AAMI Table-top steam sterilizers.
ST55
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Safety requirements for electrical equipment for measurement,
IEC 61010-2-
040 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.
Electric appliances connected to the water mains - Avoidance of
IEC 61770
backsiphonage and failure of hose-sets.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.
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