EN ISO 19023:2018 PDF

Name: EN ISO 19023:2018 — Dentistry - Orthodontic anchor screws (ISO 19023:2018)
SKU: EN ISO 19023:2018
Price: 60.09 EUR
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Dentistry - Orthodontic anchor screws (ISO 19023:2018)

Название (английский):

EN ISO 19023:2018

Dentistry - Orthodontic anchor screws (ISO 19023:2018)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 28 февраля 2018 г.
Издание:: CEN EN 19023 edition 1 version 1
ICS:: 11.060.10

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Описание (английский):

ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information. NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 19023:2018 - Dentistry - Orthodontic anchor screws (ISO 19023:2018) specifies requirements and test methods for orthodontic anchor screws (temporary intraoral skeletal anchorage devices). The standard defines how to compare physical and mechanical properties, and it gives packaging, labelling and information-to-user requirements to support clear communication between manufacturers, clinicians and testing laboratories. Note: these screws are temporary and are removed at the end of orthodontic treatment.

Key Topics and Technical Requirements

Materials

Acceptable materials reference ISO 5832‑2, ISO 5832‑3, ASTM F67 or ASTM F136. If other alloys are used, the manufacturer must declare composition components present ≥ 0.1% by mass.

Hazardous elements

Cadmium, beryllium, lead and nickel are designated hazardous; manufacturers shall state their concentrations (mass fraction %).

Dimensions and tolerances

Important dimensions (thread diameters, shaft length, neck height, head height, overall length) must be declared and measured to an accuracy of 0.05 mm (Clause 6.1).

Torsional performance

Fracture torque and insertion torque under worst‑case conditions must be specified. Fracture torque is tested per ASTM F543‑17 (test method A1) with a minimum of five specimens (Clause 6.2). Insertion torque is measured using a synthetic bone analogue (e.g., highest density Sawbones per ASTM F‑1839‑08) to simulate maximum bone density (Clause 6.3).

Reporting and compliance

Test results for each specimen must lie within the manufacturer’s declared ranges/tolerances for compliance (Clause 5.6).

Information to user, labelling and packaging

Requirements cover instructions for use, labelling content and packaging to ensure safe insertion/removal and identification (Clause 7).

Applications and Who Uses This Standard

Manufacturers - to design, test and declare material, dimensional and mechanical properties of orthodontic anchor screws for market access and product data sheets.

Clinical users (orthodontists, oral surgeons) - to compare products using standardized metrics (insertion torque, fracture torque, dimensions) for treatment planning and device selection.

Testing laboratories and conformity assessors - to perform dimensional and torsional tests in a standardized manner.

Regulators and procurement teams - to specify requirements in tenders, certificates and technical files.

Related Standards

ISO 5832‑2, ISO 5832‑3 (implant materials)

ASTM F67, ASTM F136 (titanium specifications)

ASTM F543‑17 (bone screw test methods)

ASTM F‑1839‑08 (synthetic bone)

ISO 10993‑1, ISO 7405 (biological/toxicological assessment - recommended references)

Keywords: EN ISO 19023:2018, orthodontic anchor screws, temporary skeletal anchorage, torsional performance, insertion torque, fracture torque, dental materials, packaging and labelling.

EN ISO 19023:2018 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Technical Requirements

Applications and Who Uses This Standard

Related Standards

Технические детали

ISO 19023:2018

Dentistry — Orthodontic anchor screws

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BS EN ISO 10993-11:2018

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SIST EN ISO 7405:2025

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