Norm

NEN-EN 1641:2009 en

Tandheelkunde - Medische hulpmiddelen voor tandheelkunde - Materialen

49,30

Over deze norm

Status Definitief
Aantal pagina's 11
Commissie Tandheelkunde
Gepubliceerd op 01-11-2009
Taal Engels
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative and orthodontic materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

Details

ICS-code 11.060.10
Nederlandse titel Tandheelkunde - Medische hulpmiddelen voor tandheelkunde - Materialen
Engelse titel Dentistry - Medical devices for dentistry - Materials
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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