Qualifications of the users
There are two types of users who may operate the sterilizer:
The ADMINISTRATOR (ADM) 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.
The USERS are the persons who use the sterilizer according to the ADMINISTRATOR 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.
Conformity to European Standards and Directives
Medical Device Directive 93/42/CEE for devices class IIb, in accordance with the Rule 15 – ANNEX IX of the above Directive.
Directive 97/23/CEE (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.
See the Declaration of Conformity and the Warranty Card in the enclosed documents.
Introduction
5
