EN ISO 16443:2014

Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)

Publication date:   Sep 19, 2014

General information

60.60 Standard published   Jul 16, 2014

CEN

CEN/TC 55 Dentistry

European Norm

01.020   Terminology (principles and coordination) | 11.060.01   Dentistry in general

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Scope

ISO 16443:2014 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from ISO 16443:2014.
The following devices are also excluded from the scope of ISO 16443:2014.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions):

epithesis implant;
craniofacial implant;
maxillofacial implant.

Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance:

orthodontic implant.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
EN ISO 16443:2014
60.60 Standard published
Jul 16, 2014