Conformity
Lara | Instructions for Use | RIL-1 W&H Med ENG Rev06 | 14/04/2022 | © W&H Sterilization Srl
5
CONFORMITY TO EUROPEAN REGULATIONS, STANDARDS AND
DIRECTIVES
Sterilizer conforms with the following Regulations, Standards and
Directives:
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 Directive (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.
Standards
and
Directives
Description
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
: Lara sterilizers can be validated in accordance to EN ISO 17665-1.
Note
: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.