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
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
02-Oct-2019
Completion Date
02-Oct-2019

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SLOVENSKI STANDARD
SIST EN ISO 20896-1:2020
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)
SIST EN ISO 20896-1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20896-1:2020
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SIST EN ISO 20896-1:2020
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.
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SIST EN ISO 20896-1:2020
EN ISO 20896-1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 20896-1:2020
EN ISO 20896-1:2019 (E)
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.
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SIST EN ISO 20896-1:2020
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SIST EN ISO 20896-1:2020
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
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SIST EN ISO 20896-1:2020
ISO 20896-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 20896-1:2020
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 2019 – All rights reserved iii
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SIST EN ISO 20896-1:2020
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

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

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

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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 endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 9, Dental

CAD/CAM Systems.
A list of all parts in the ISO 20896 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 20896-1:2020
ISO 20896-1:2019(E)
Introduction

Dental CAD/CAM systems that produce indirect dental restorations require a three dimensional

digitized description, often called a digital impression, of a patient's dentition as a starting point for the

design and fabrication of inlays, crowns, bridges and larger fixed or removable appliances. The device

that digitizes the three dimensional surface shall be sufficiently accurate to enable the design and

manufacture of a clinically acceptable restoration.

This document describes test methods for evaluating the accuracy of digitizing devices that acquire

data by direct scanning of a patient's dentition with a manually guided; that is hand-held, device in

order to obtain a digital impression. A companion document, ISO 12836, provides test methods for

assessing the accuracy of fixed devices for digitizing physical impressions or models cast from such

impressions. Separate standards were deemed necessary after it became apparent that two of the test

objects described in ISO 12836 are unsuited for successful interpretation of data acquired from these

objects with a hand-held scanning device.

NOTE Testing conducted outside the oral cavity on objects that are ideal − in having both surface

characteristics suitable for a given scanning technology and sufficient recognizable features for registration

algorithms to function well − will give a better result than can be achieved under less ideal, clinical conditions.

© ISO 2019 – All rights reserved v
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SIST EN ISO 20896-1:2020
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SIST EN ISO 20896-1:2020
INTERNATIONAL STANDARD ISO 20896-1:2019(E)
Dentistry — Digital impression devices —
Part 1:
Methods for assessing accuracy
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary

ISO 3534-1, Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in

probability

ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General

principles and definitions
ISO 6873:2013, Dentistry — Gypsum products
ISO 18739:2016, Dentistry — Vocabulary of process chain for CAD/CAM systems
ISO 20795-1, Dentistry — Base polymers — Part 1: Denture base polymers
ISO 22112, Dentistry — Artificial teeth for dental prostheses

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated

terms (VIM)

ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in

me a s ur ement (GUM: 1995)
3 Terms and definitions

For the purposes of this document, the terms and definitions from ISO 1942, ISO 3534-1, ISO 5725-1,

ISO 18739, ISO/IEC Guide 99, ISO/IEC Guide 98-3, and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
© ISO 2019 – All rights reserved 1
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SIST EN ISO 20896-1:2020
ISO 20896-1:2019(E)
3.1
accuracy
closeness of agreement between a test result and an accepted reference value
[SOURCE: ISO 18739:2016, 3.2.1]

Note 1 to entry: Accuracy is a qualitative concept. For the purpose of this document accuracy is to be expressed

as specified in 5.4.3.
3.2
bias

expectation of the difference between test results and an accepted reference value

[SOURCE: ISO 3534-1:2006, 1.33, modified to specify test results and reference value]

Note 1 to entry: For the purpose of this document bias is to be expressed as given in 5.4.2.

3.3
digital impression

acquisition of a data set with the numerical three dimensional representation of the surfaces from the

patient directly, or the outcome of such an acquisition
[SOURCE: ISO 18739:2016, 3.1.20, modified]

Note 1 to entry: This definition extends ISO 18739:2016, 3.1.20 to include the outcome of data acquisition.

Note 2 to entry: A digital impression may be supplemented by data on surface colour.

Note 3 to entry: A digital impression is distinct from a virtual model as defined in ISO 18739:2016, 3.1.40. A

virtual model is the graphical output from design or similar software; a digital impression is the input to this

software.
3.4
digital impression device

combination of a hand-held scanning device (3.6) suited for use in the oral cavity, and computer hardware

and software that outputs a numerical, three dimensional description of scanned surfaces

3.5
dimension of interest

distance between features of a test object that are required to be both measured independently as a

reference or true value and estimated by the digital impression d
...

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