EN ISO 20896-1:2019

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

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.

Zahnheilkunde - Digitale Abformgeräte - Teil 1: Verfahren zur Bewertung der Genauigkeit (ISO 20896-1:2019)

Dieses Dokument legt Prüfverfahren und Vorgehensweisen zur Beurteilung der Genauigkeit einer dreidimensionalen, numerischen Beschreibung von intraoralen Oberflächen, die mit einem handgehaltenen Scanner direkt am Patienten erfasst werden, fest. Die Prüfverfahren gelten nicht für Ultraschall-, Röntgen- oder Magnetresonanz-Bildgebungsverfahren.
ANMERKUNG ISO 12836 legt die Prüfverfahren für die Beurteilung der Genauigkeit von Digitalisierungsgeräten fest, die einen fest stehenden oder einen mechanisch geführten Scanner verwenden.

Médecine bucco-dentaire - Dispositifs d'empreinte numérique - Partie 1: Méthodes d'évaluation de l'exactitude (ISO 20896-1:2019)

Le présent document spécifie des méthodes d'essai et des modes opératoires d'évaluation de l'exactitude d'une description numérique tridimensionnelle de surfaces intrabuccales acquises directement à partir d'un patient à l'aide d'un dispositif de balayage manuel. Les méthodes d'essai ne sont pas applicables aux méthodes d'imagerie par résonance ultrasonore, radiographique ou magnétique.
NOTE       L'ISO 12836 spécifie les méthodes d'essai destinées à évaluer l'exactitude des dispositifs de numérisation qui utilisent un dispositif de balayage fixe ou guidé mécaniquement.

Zobozdravstvo - Digitalni pripomočki za sisteme - 1. del: Metode za ugotavljanje točnosti (ISO 20896-1:2019)

Ta standard opisuje preskusne metode, ki se uporabljajo za ocenjevanje ponovljivosti, obnovljivosti in točnosti dentalnih naprav za 3D-meroslovje. Standard se uporablja za zobozdravstvene sisteme CAD/CAM na mestu zdravljenja. Področje uporabe tega dokumenta ne vključuje edinstvenih sistemov z drugimi specifičnimi uporabami 3D-meroslovja na področju zobozdravstva, kot so na primer 3D-računalniška tomografija, slikanje z magnetno resonanco in stereofotogrametrija.

General Information

• Status: Published
• Publication Date: 01-Oct-2019
• Withdrawal Date: 29-Apr-2020
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 02-Oct-2019
• Completion Date: 02-Oct-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 20896-1:2020 - Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO 20896-1:2019)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2020
Zobozdravstvo - Digitalni pripomočki za sisteme - 1. del: Metode za ugotavljanje
točnosti (ISO 20896-1:2019)
Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy (ISO
20896-1:2019)
Zahnheilkunde - Digitale Abformgeräte - Teil 1: Verfahren zur Bewertung der
Genauigkeit (ISO 20896-1:2019)
Médecine bucco-dentaire - Dispositifs d'empreinte numérique - Partie 1: Méthodes
d'évaluation de l'exactitude (ISO 20896-1:2019)
Ta slovenski standard je istoveten z: EN ISO 20896-1:2019
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
35.240.10 Računalniško podprto Computer-aided design
snovanje (načrtovanje, (CAD)
oblikovanje) (CAD)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20896-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.060.01
English Version
Dentistry - Digital impression devices - Part 1: Methods for
assessing accuracy (ISO 20896-1:2019)
Médecine bucco-dentaire - Dispositifs d'empreinte Zahnheilkunde - Genauigkeit von handgehaltenen
numérique - Partie 1: Méthodes d'évaluation de Scanner für CAD/CAM-Systeme am Behandlungsstuhl
l'exactitude (ISO 20896-1:2019) (ISO 20896-1:2019)
This European Standard was approved by CEN on 27 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20896-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20896-1:2019) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20896-1:2019 has been approved by CEN as EN ISO 20896-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 20896-1
First edition
2019-08
Dentistry — Digital impression
devices —
Part 1:
Methods for assessing accuracy
Médecine bucco-dentaire — Dispositifs d'empreinte numérique —
Partie 1: Méthodes d'évaluation de l'exactitude
Reference number
ISO 20896-1:2019(E)
©
ISO 2019
ISO 20896-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 20896-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General . 3
4.2 Reference measurement of test objects . 3
5 Test Methods . 4
5.1 Test objects . 4
5.1.1 General. 4
5.1.2 Preparation . 4
5.1.3 Measurement of reference values . 4
5.2 Test conditions . 5
5.2.1 Ambient conditions . 5
5.2.2 Scanning pattern . 5
5.2.3 Scanning time . 5
5.2.4 Number of scans . 5
5.3 Processing of the digital impression . 5
5.3.1 General. 5
5.3.2 Dimensions of interest . 5
5.3.3 Determination of dimensions . 5
5.4 Assessment of accur acy . 6
5.4.1 Statistical analysis . . 6
5.4.2 Expression of bias . 6
5.4.3 Expression of accuracy . 6
6 Test Report . 7
6.1 General . 7
6.2 Device . 7
6.3 Test object . 7
6.4 Test method . 7
6.5 Test results. 8
Annex A (normative) Test object — Crown preparation . 9
Annex B (normative) Test object — Inlay preparation .11
Annex C (normative) Test object — Full arch .13
Bibliography .15
ISO 20896-1:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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different types of ISO documents should be noted. This document was drafted in accordance with the
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorse
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