EN ISO 20896-1:2019 PDF

Name: EN ISO 20896-1:2019 — Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO 20896-1:2019)
SKU: EN ISO 20896-1:2019
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Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO 20896-1:2019)

Название (английский):

EN ISO 20896-1:2019

Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO 20896-1:2019)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 23
Дата публикации:: 2 октября 2019 г.
Издание:: CEN EN 20896 edition 1 version 1
ICS:: 11.060.01

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Описание (английский):

This document specifies test methods and procedures for assessing the accuracy of a three dimensional numerical description of intra-oral surfaces acquired directly from a patient with a hand-held scanning device. The test methods are not applicable to ultrasonic, radiographic or magnetic resonance imaging methods. NOTE ISO 12836 specifies the test methods for the assessment of accuracy of digitizing devices that use a fixed or a mechanically guided scanning device.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 20896-1:2019 - Dentistry: Digital impression devices (Part 1: Methods for assessing accuracy) defines standardized test methods to evaluate the accuracy of three‑dimensional digital impressions captured directly from patients using hand‑held intra‑oral scanners (digital impression devices). It specifies how to prepare test objects, perform scans, process digital impressions and report results. The standard does not apply to ultrasonic, radiographic or magnetic resonance imaging methods and complements ISO 12836, which covers fixed or mechanically guided digitizing devices.

Key Topics and Requirements

Scope and applicability

Focused on hand‑held dental intra‑oral scanners used in clinical settings for CAD/CAM workflows.
Excludes imaging modalities such as ultrasound, X‑ray and MRI.

Test objects

Normative annexes define representative test objects (e.g., crown preparation, inlay preparation, full arch) used for repeatable evaluation.

Reference measurements

Procedures for obtaining reference values of test objects before comparison with scanner output.

Test conditions

Controls and documentation of ambient conditions, recommended scanning pattern, scanning time and number of repeated scans to ensure reproducibility.

Processing and analysis

Guidelines for post‑processing digital impressions, defining dimensions of interest and methods to determine measured values.

Accuracy assessment

Statistical treatment of results, expression of bias (trueness) and precision, and overall expression of accuracy in accordance with ISO measurement vocabulary.

Test report

Required content for reporting: device identification, test object details, test method, processing steps and summarized results.

Practical Applications

Quality assurance and R&D for dental CAD/CAM manufacturers developing or validating intra‑oral scanners.

Clinical evaluation and procurement: clinicians and dental laboratories can compare device performance for crown, inlay and full‑arch workflows.

Regulatory and conformity assessment: provides objective, reproducible methods for demonstrating scanner accuracy in product submissions.

Independent testing laboratories and academic researchers performing comparative studies or method validation.

Related Standards

ISO 12836 - Test methods for fixed or mechanically guided digitizing devices (complementary)

Referenced documents: ISO 5725 (accuracy/trueness/precision), ISO 1942 (dental vocabulary), ISO/IEC Guides on measurement uncertainty

Keywords: EN ISO 20896-1:2019, ISO 20896-1, digital impression devices, intra‑oral scanners, accuracy assessment, dental CAD/CAM, test methods, hand‑held scanning device.

EN ISO 20896-1:2019 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications

Who Should Use This Standard

Related Standards

Технические детали

ISO 20896-1:2019

Dentistry — Digital impression devices — Part 1: Methods for assessing accuracy

SIST EN ISO 12836:2015

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ISO 5725-6:1994/Cor 1:2001

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SIST EN ISO 20896-1:2020

Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO 20896-1:2019)