SIST EN ISO 16443:2014 PDF
Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)
Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 20
- Дата публикации:
- 5 сентября 2014 г.
- ICS:
- 01.040.11
- Технический комитет:
- VAZ - Healthcare
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
EN ISO 16443:2014 / ISO 16443:2014 - "Dentistry - Vocabulary for dental implant systems and related procedure" is an international terminology standard published by ISO and adopted by CEN. It defines standardized terms and definitions for dental implants, implant components, instruments, accessories and commonly used clinical and surgical concepts in oral implantology. The standard excludes grafting materials and membranes and excludes epithesis, craniofacial, maxillofacial and orthodontic implants from its scope.
Key topics
This vocabulary standard organizes and harmonizes core terminology used across the dental implant industry. Key topics covered include:
- Dental implant and subtypes (e.g., endosseous, intramucosal, zygoma implant)
- Dental implant system and related concepts (implant kit, implant component, implant assembly)
- Implant body, implant body endosseous zone and tissue interface surface
- Connecting interface, including platform-switching design and anti-rotation features (internal/external)
- Implant abutments (straight, angulated, castable, CAD/CAM, ball/magnetic attachments) and implant connecting parts
- Transmucosal components, surface treatments and coatings
- Terminology for clinical and surgical concepts used in implant procedures
- Normative references and alignment with ISO terminology principles (ISO 1942, ISO 704, ISO 1087-1, ISO 860 and ISO 10241-1)
Note: EN ISO 16443:2014 is a terminology standard - it provides definitions and naming conventions rather than performance or testing requirements.
Applications
EN ISO 16443:2014 is practical for anyone who needs consistent, international dental implant terminology:
- Dental clinicians and surgeons - for clear communication in clinical records and referrals
- Manufacturers and product designers - to standardize product descriptions, labels and instructions for use (IFU)
- Regulatory and quality teams - to align documentation for conformity assessment and submissions
- Dental laboratories and CAD/CAM technicians - to ensure consistent component specification and ordering
- Educators, researchers and translators - for teaching, publications and multilingual consistency
- Procurement and supply chain - for unambiguous product cataloguing and contracts
Related standards
- ISO 1942 - Dentistry - Vocabulary (general dental terms)
- ISO terminology works referenced in the standard: ISO 704, ISO 860, ISO 1087‑1, ISO 10241‑1
- EN adoption: EN ISO 16443:2014 (CEN endorsement)
Using EN ISO 16443:2014 helps reduce ambiguity, improve technical communication, and support regulatory compliance across the dental implant ecosystem. Keywords: ISO 16443:2014, dental implants, implant systems, implant vocabulary, implant components, implant abutment, platform switching.
Технические детали
- SKU
- SIST EN ISO 16443:2014
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