ISO 16443:2014
Dentistry — Vocabulary for dental implants systems and related procedure
Dentistry — Vocabulary for dental implants systems and related procedure
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 12
- Дата публикации:
- 16 июля 2014 г.
- Издание:
- ISO IS 16443 edition 1 version 1
- ICS:
- 01.020
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.
Abstract
Overview
ISO 16443:2014 - Dentistry - Vocabulary for dental implant systems and related procedure - provides a standardized vocabulary for dental implants, implant systems, instruments, accessories and the most commonly used clinical and surgical terms in oral implantology. The standard defines terms such as dental implant, implant body, implant abutment, connecting interface, abutment screw, and a wide range of ancillary devices (e.g., profile drills, torque wrenches, impression copings). It excludes grafting materials and membranes and does not cover epithesis/craniofacial/maxillofacial implants or orthodontic implants.
Key topics
- Standardized terminology for implant systems
- Definitions for single- and multi-part implants (e.g., monopart/one-piece, two-part, multi-part).
- Terms for implant components: implant body, transmucosal component, implant connecting part, implant analogue.
- Clinical and surgical concepts
- Terms related to placement, healing and prosthetic connection (e.g., transmucosal healing component, cover screw).
- Ancillary instruments and accessories
- Vocabulary for tools used in implantology: implant screwdriver, torque wrench, profile drill, implant insertion preassembled device, template.
- Interface and surface terminology
- Definitions for connecting interface, anti-rotation feature, tissue interface surface, and surface treatments/coatings.
- Terminology methodology
- Prepared according to ISO terminology principles (ISO 704, ISO 860, ISO 1087‑1, ISO 10241‑1) and published in ISO’s Online Browsing Platform (OBP).
Practical applications
Who uses ISO 16443:2014 and why:
- Manufacturers - consistent labeling, product specifications, technical files and instructions for use for dental implant systems.
- Regulatory bodies & notified bodies - harmonized terms for conformity assessment and regulatory submissions.
- Dental clinicians & laboratories - clear, shared vocabulary for treatment planning, surgical procedures and laboratory workflows.
- Procurement and purchasing - standardized product descriptions to avoid ambiguity in tenders and contracts.
- Educators and technical writers - consistent terminology for training materials, standards-based curricula and documentation.
Using ISO 16443 helps improve clarity across product development, clinical documentation and international communication, reducing misinterpretation of implant-related terms and supporting interoperability in dentistry.
Related standards
- ISO 1942 - Dentistry - Vocabulary (normative reference)
- ISO 704, ISO 860, ISO 1087‑1, ISO 10241‑1 - terminology principles and methods
- ISO Online Browsing Platform (OBP) - access to published terminology entries
Keywords: ISO 16443:2014, dental implants vocabulary, dental implant terminology, implant systems, implant instruments, dentistry standard.
Технические детали
- Технический комитет
- ISO/TC 106/SC 3 - Terminology
- SKU
- ISO 16443:2014
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