EN ISO 27020:2019 PDF

Name: EN ISO 27020:2019 — Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)
SKU: EN ISO 27020:2019
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Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)

Название (английский):

EN ISO 27020:2019

Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 3 июля 2019 г.
Издание:: CEN EN 27020 edition 2 version 1
ICS:: 11.060.10

Тип поставки:

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Язык документа:

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Срок поставки:4 раб. дн. (перевод)

Цена:300 €

Описание (английский):

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 27020:2019 - Dentistry: Brackets and tubes for use in orthodontics (ISO 27020:2019) specifies requirements and test methods to enable meaningful comparison of orthodontic brackets and tubes used in fixed orthodontic appliances. The standard covers functional dimensions, angular geometry, chemical ion release (corrosion/ion release testing), and required packaging and labelling information. It is a CEN-endorsed European adoption of ISO 27020:2019 and supersedes earlier editions.

Key topics and technical requirements

Dimensional and geometric requirements

Definitions and measurement procedures for critical features such as slot height, slot depth, slot length, in‑out, angulation, angle of torque, and rotational offset to ensure interchangeability and predictable clinical performance.
Standardized apparatus and measurement procedures for accurate, repeatable dimension assessment.

Chemical release and corrosion

Test methods to evaluate chemical ion release from metallic brackets and tubes, including a static immersion corrosion test added in the 2019 edition.
Identification of hazardous elements (cadmium, beryllium, lead, nickel) whose concentrations manufacturers must declare as mass fractions (%).

Packaging and labelling

Requirements for information that must be supplied to the user, including packaging integrity, traceability and essential product labelling.

Normative references

Uses terminology and definitions from ISO 1942 and refers to corrosion test methods in ISO 10271.

Practical applications and who uses it

Manufacturers and suppliers of orthodontic brackets and tubes use EN ISO 27020:2019 to design, validate and declare product dimensions and corrosion behaviour for regulatory compliance and product specifications.

Orthodontists and dental clinicians rely on standardized dimensional and labelling information to select compatible brackets/tubes and archwires, improving clinical predictability.

Laboratories and test houses perform the standardized measurement and corrosion tests to generate comparative data and supporting documentation.

Regulatory bodies and procurement teams use the standard as a benchmark for product evaluation, tendering and conformity assessment.

Related standards

ISO 10993‑1 and ISO 7405 - biological evaluation of medical/dental devices (biocompatibility) - EN ISO 27020:2019 does not replace these requirements.

ISO 1942 - dentistry vocabulary.

ISO 10271 - corrosion test methods for metallic dental materials.

EN ISO 27020:2019 helps ensure consistent, comparable information on orthodontic brackets and tubes - improving product interoperability, safety declarations (hazardous elements), and clinical decision-making.

EN ISO 27020:2019 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses it

Related standards

Технические детали

ISO 27020:2019

Dentistry — Brackets and tubes for use in orthodontics

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

SIST EN ISO 10271:2020

Dentistry - Corrosion test methods for metallic materials (ISO 10271:2020)

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)