W&H Lexa PLUS - Conformity

Conformity
Lexa PLUS| Instructions for Use |RIS-311 ENG Rev03 |29/08/2022 |© W&H Sterilization Srl 5
CONFORMITY TO EUROPEAN AND AMERICAN REGULATIONS,
STANDARDS AND DIRECTIVES
Sterilizer conforms with the following Regulations, Standards and
Directives:
Standards
and
Directives
Description
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).
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 Directive (WEEE).
CSA C22.2 No.
61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
UL 61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Standards
and
Directives
Description
ASME
Boiler and pressure vessel code.
EN 13060
Small steam sterilizers.
ANSI/AAMI
ST55
Table-top 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: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.