CEN TC 55 - DENTISTRY NORMAPME Mirror Committee

The European and International Federation of Dental Technicians (FEPPD), member of NORMAPME, represents European wide the majority of this profession. Their offices are in the NORMAPME/UEAPME building and therefore contact is at ease. They have provided the NORMAPME expert for CEN TC 55, Mrs Hana Dohalova.

Thus, NORMAPME is represented in CEN TC 55, the Advisory Board for Health Standards (ABHS) and the newly created Task Force on denture base risk assessment ( CEN TC 55/WG 8). The work of this TC WG had been requested for several years and was finally created after the decision of the CEN TC plenary meeting in February 2007. The work will include the topic occupational health and safety questions. The reason for the creation of this TF was the recognition of the fact that denture base polymer materials may be a risk material for dental personnel including dental technicians as well as for patients because of the monomer content. NORMAPME expert has been pointing out these risks for years. It is to note with satisfaction that the work can now start.

In the past years, NORMAPME already succeeded by leading ISO to adopt a decision on limited use of beryllium containing alloys that are poisonous for patients and dental technicians.

Furthermore, NORMAPME supports good manufacturing procedures for custom-made medical devices and favours European legislation and standardisation versus national legislation and standardisation. Most custom made devices are manufactured by micro and small enterprises which account for 2.75 % of all SMEs to the prescription of a qualified professional. This complicates the 'putting into service' and the use by 'final user'.

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