Norm

NPR-CEN/TR 12401:2009 en

Tandheelkunde - Leidraad voor de classificatie van tandheelkundige apparatuur en toebehoren

49,30

Over deze norm

Status Definitief
Aantal pagina's 10
Commissie Tandheelkunde
Gepubliceerd op 01-07-2009
Taal Engels
Dental products are marketed for long term, short term and transient use in the mouth. A large number of items have been developed to assist in the treatment and prevention of oral diseases and the handling of dental materials. In contrast to pharmaceuticals (medicinal products), many dental materials are intended to perform as implanted devices in the oral cavity with a minimum of degradation and release of substances, i.e. their main action is to replace lost and defective teeth and oral tissue. Some materials contain elements that may initiate toxic or allergic responses. Other materials have additions of medicinal substances. Many dental materials, instruments, equipment and disposables are covered by the Council Directive 93/42 EEC of 14 June 1993 concerning medical devices. The Directive also provides rules for the classification of medical devices based on risk and intended use. It is the manufacturer's responsibility to classify the product according to the rules of the Directive. The classification should be acceptable to Notified Bodies (NB) and Competent Authorities (CA). The Directive describes procedures for resolving any disputes over classification between manufacturers, Notified Bodies and Competent Authorities.

Details

ICS-code 11.060.01
Nederlandse titel Tandheelkunde - Leidraad voor de classificatie van tandheelkundige apparatuur en toebehoren
Engelse titel Dentistry - Guidance on the classification of dental devices and accessories
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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