Conformity
CONFORMITY TO EUROPEAN AND AMERICAN 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).
CSA C22.2 No.
61010-1-12
Safety requirements for electrical equipment for measurement, control and laboratory use, general requirements.
UL 61010-1:2012
Safety requirements for electrical equipment for measurement, control and laboratory use, general requirements.
ASME
Boiler and pressure vessel code.
EN 13060
Small steam sterilizers.
ANSI/AAMI
ST55:2010
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.
MN-111 | Service book | Errors and Troubleshooting MN-111 ENG Rev08 | 2019/06/21 | © 2019 W&H Sterilization Srl
5
