Overview

This European Standard has been prepared by CEN/TC 55/WG 7 "Steering committee" (secretariat: DIN). At DIN Working Group NA 014 BR-01 SO "European Standardisation Committee" as well as the product committees concerned of NADENT are responsible. This document has been prepared under a mandate given to CEN by the European Commission and the European free trade Association to provide a means of conforming to Essential Requirements of EU Directive 93/42/EEC concerning medical devices. There are three levels of European Standards dealing with medical devices used in dentistry: - Level 1: General requirements for medical devices; - Level 2: Requirements for families of medical devices used in dentistry; - Level 3: Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices used in dentistry. This standard is a level 2 standard. This standard indicates that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level. Tests verifying conformity with this standard are contained in the corresponding standards of level 3, if applicable. Standard EN 1642 specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Document: references other documents

Responsible national committee

NA 014 BR-01 SO - European Standardisation  

Responsible european committee

CEN/TC 55/WG 7 - Steering Committee