5
Introduction
ANSI/AAMI ST55: Table-top steam sterilizers.
Qualifications of the users
There are two types of users who may operate the sterilizer:
- The Users
are the persons who use the sterilizer according to the ADVANCED USER’s instructions. They must be trained in
operating the sterilizer and in its safe use. Training must be regular and evidence of the understanding shall be recorded.
- The Advanced user
is the head of the clinic/practice, who is legally responsible for the efficiency of the hygiene protocol in
place as well as the sterilization process. He/she is also responsible for the USERS’ training and the correct operation and
maintenance of the equipment.
Conformity to European Standards and Directives
Medical Device Directive 93/42/EEC for devices class IIb, in accordance with the Rule 15 – ANNEX IX of the Directive.
Directive PED 2014/68/EU (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.
Directive 2012/19/EU (WEEE) for disposal of parts coming from electrical or electronic products.
See the Declaration of Conformity and the Warranty Card in the enclosed documents.
IEC 61010-2-40: 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 61010-1: Safety requirements for electrical equipment for measurement, control and laboratory use, general
requirements
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