SIST EN ISO 15841:2014 PDF

Name: SIST EN ISO 15841:2014 — Dentistry - Wires for use in orthodontics (ISO 15841:2014)
SKU: SIST EN ISO 15841:2014
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Dentistry - Wires for use in orthodontics (ISO 15841:2014)

Название (английский):

SIST EN ISO 15841:2014

Dentistry - Wires for use in orthodontics (ISO 15841:2014)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 18
Дата публикации:: 14 октября 2014 г.
ICS:: 11.060.10
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 15841:2014 specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. ISO 15841:2014 gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labelling information.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 15841:2014 (ISO 15841:2014) - "Dentistry - Wires for use in orthodontics" - specifies requirements and test methods for wires used in fixed and removable orthodontic appliances. The standard covers preformed orthodontic archwires but explicitly excludes springs and other preformed components. It defines how manufacturers must present physical and mechanical properties, required test methods, and packaging and labelling information for orthodontic wires.

Key topics and technical requirements

Scope and classification

Applies to wires for fixed and removable orthodontic appliances; excludes springs/other preformed parts.
Wires are classified by elastic behaviour: Type 1 (linear elastic on unloading up to 50 °C) and Type 2 (nonlinear elastic on unloading up to 50 °C).

Dimensions

Cross-sectional dimensions (diameter, width, height, diagonal) stated to the nearest 0.01 mm; multistrand wires reported as internal tube dimensions.
Measurement devices must have accuracy of 0.005 mm (callipers, micrometers, optical comparators).

Mechanical properties

Manufacturers must declare properties verified by testing. For Type 1 wires: modulus of elasticity (GPa), 0.2% proof strength (MPa), elongation at fracture (%), force-deflection rate (N/mm), and 0.1 mm offset bending force (N).
For Type 2 wires: unloading force magnitudes at deflections of 3.0, 2.0, 1.0 and 0.5 mm and permanent deflection after unloading.
Different wire segments with different properties must be tested and reported separately.

Austenite-finish temperature (Taf)

For Type 2 (shape‑memory) wires, Taf shall be reported to the nearest 1 °C, determined by differential scanning calorimetry (DSC) or by bend-and-free-recovery per ASTM F2082.

Chemical hazards

Manufacturer must state mass-fraction concentrations for designated hazardous elements: cadmium, beryllium, lead, and nickel.

Testing and sampling

Sampling requires six specimens from a single batch; manufacturer-recommended heat treatment (if any) is applied before testing.

Packaging and labelling

Standard defines required user information on packaging and labelling to ensure traceability and safe clinical use.

Applications and users

Intended for orthodontic wire manufacturers, quality control and testing laboratories, regulatory authorities, procurement specialists, and clinicians/orthodontists who need consistent, comparable product data.

Useful for product specification, compliance testing, clinical selection of archwires, and supplier benchmarking.

Related standards

ISO 1942 (dental vocabulary)

ISO 6892-1 (tensile testing)

ASTM F2082 (bend and free recovery for NiTi transformation temperature)

ISO 10993 and ISO 7405 (biological hazard assessment guidance referenced in the ISO 15841 introduction)

Keywords: EN ISO 15841:2014, ISO 15841:2014, orthodontic wires, archwires, austenite finish temperature, wire testing, orthodontics, mechanical properties, packaging and labelling.

SIST EN ISO 15841:2014 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 15841:2014

Dentistry — Wires for use in orthodontics

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

SIST EN ISO 6892-1:2020

Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

ISO 15841:2014/Amd 1:2020

Dentistry — Wires for use in orthodontics — Amendment 1