SIST EN ISO 22683:2022

Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems (ISO 22683:2022)

This document specifies a test method to evaluate the rotational adaptability between an implant body and an implant abutment in a dental implant system.
This document is applicable to the implant systems which do not have a friction-fit between implant body and implant abutment but incorporate only an anti-rotational feature between these components. Analog or replica components cannot be used to evaluate the adaptability of dental implant systems.

Zahnheilkunde - Rotationspassungsprüfung zwischen Implantatkörper und Implantatabutment bei dentalen Implantatsystemen (ISO 22683:2022)

Dieses Dokument legt ein Prüfverfahren zur Bewertung der Rotationspassung zwischen einem Implantatkörper und einem Implantatabutment in einem Dentalimplantatsystem fest.
Dieses Dokument gilt für Implantatsysteme, die keine Reibungspassung zwischen Implantatkörper und Implantatabutment aufweisen, sondern nur eine Anti-Rotationsfunktion zwischen diesen Komponenten besitzen. Analoge oder Replika-Komponenten können nicht für die Bewertung der Passungsfähigkeit von Dentalimplantatsystemen verwenden werden.

Médecine bucco-dentaire - Essai d'évaluation de la liberté rotationnelle entre le corps d'implant et le pilier implantaire des systèmes d'implants dentaires (ISO 22683:2022)

Le présent document spécifie une méthode d’essai pour évaluer la liberté rotationnelle du corps d’implant et du pilier implantaire d’un système d’implant dentaire.
Le présent document est applicable aux systèmes d’implants qui n’ont pas d’assemblage par friction entre le corps d’implant et le pilier implantaire mais qui intègrent seulement un dispositif anti-rotationnel entre ces composants. Des analogues ou des répliques ne peuvent pas être utilisés pour évaluer la compatibilité des systèmes d’implants dentaires.

Zobozdravstvo - Rotacijski preskus prilagodljivosti med telesom implantata in nosilcem vsadka v sistemih zobnih vsadkov (ISO 22683:2022)

Ta dokument določa preskusno metodo za vrednotenje rotacijske prilagodljivosti med telesom implantata
in nosilcem vsadka v sistemu zobnih vsadkov.
Ta dokument se uporablja za sisteme zobnih vsadkov, pri katerih telo vsadka in nosilec vsadka nista povezana s pomočjo trenja, temveč le s pomočjo varovala proti rotaciji.
Za vrednotenje prilagodljivosti sistemov zobnih vsadkov ni mogoče uporabiti analognih komponent ali njihovih replik.

General Information

• Status: Published
• Public Enquiry End Date: 14-Sep-2021
• Publication Date: 23-Aug-2022
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Aug-2022
• Due Date: 09-Oct-2022
• Completion Date: 24-Aug-2022
• Ref Project: EN ISO 22683:2022 - Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems (ISO 22683:2022)

Overview

EN ISO 22683:2022 - "Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems" - specifies a standardized test method to evaluate the rotational adaptability (rotational clearance angle) between an implant body and an implant abutment. The standard applies to implant systems that rely solely on an anti-rotational feature (for example hexagonal connections) rather than a friction-fit. It requires tests on representative, finished components (not analogs or replicas) and documents the measurement, reporting and sampling approach.

Key topics and requirements

• Scope: Applicable only to systems without friction-fit; analog/replica components are not permitted.
• Definitions: Clear terms such as rotational angle (angle measured when an abutment is rotated clockwise and counter‑clockwise without screw/cement) and rotational adaptability.
• Sampling: Test assemblies comprise five implant bodies and five matching abutments.
• Apparatus:
  • A rotatable testing device with two parts: a goniometer and a jig to hold the components.
  • The goniometer must measure to within 0.5°.
  • The two parts must not contact directly to avoid extra rotational friction; the jig must not deform specimens.
• Procedure:
  • Implant body fixed with axis perpendicular to lower jig surface.
  • Abutment seated passively (no screw, cement or preload) and rotated both clockwise and counter‑clockwise to its limits.
  • Measure maximum rotational angle (θ) for each assembly.
  • Repeat for five assemblies and calculate mean and standard deviation.
• Test report: Must include product identification (manufacturer, catalogue/lot numbers), materials, geometric dimensions, test method and goniometer spec, raw results, mean and standard deviation, testing site/date, sampling method, and any anomalies.

Applications and users

• Manufacturers: validate design tolerances and quality control of implant‑abutment interfaces.
• Test laboratories: perform standardized rotational adaptability testing for product evaluation and batch verification.
• R&D and QA teams: compare connection designs, optimize anti‑rotational geometries, and monitor manufacturing variability.
• Regulatory/Notified bodies and procurement: use standardized test data for product assessment and conformity evidence.
• Dental engineers and clinicians (indirectly): rely on manufacturers’ test results to ensure predictable prosthetic positioning and resistance to loosening.

Practical benefits include consistent measurement of rotational clearance to reduce prosthesis loosening risk, improve occlusal accuracy, and support supplier claims with standardized data.

Related standards

• ISO 1942 - Dentistry - Vocabulary
• ISO 16443 - Dentistry - Vocabulary for dental implant systems and related procedures
• ISO 14801 - Dentistry - Dynamic loading test for endosseous dental implants

Keywords: EN ISO 22683:2022, rotational adaptability, dental implant systems, implant body, implant abutment, rotational angle, goniometer, anti-rotational feature.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2022
Zobozdravstvo - Rotacijski preskus prilagodljivosti med telesom implantata in
nosilcem vsadka v sistemih zobnih vsadkov (ISO 22683:2022)
Dentistry - Rotational adaptability test between implant body and implant abutment in
dental implant systems (ISO 22683:2022)
Zahnheilkunde - Rotationspassungsprüfung zwischen Implantatkörper und
Implantatabutment bei dentalen Implantatsystemen (ISO 22683:2022)
Médecine bucco-dentaire - Essai d'évaluation de la liberté rotationnelle entre le corps
d'implant et le pilier implantaire des systèmes d'implants dentaires (ISO 22683:2022)
Ta slovenski standard je istoveten z: EN ISO 22683:2022
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22683
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 11.060.15
English Version
Dentistry - Rotational adaptability test between implant
body and implant abutment in dental implant systems (ISO
22683:2022)
Médecine bucco-dentaire - Essai d'évaluation de la Zahnheilkunde - Passungsprüfung zwischen
liberté rotationnelle entre le corps d'implant et le pilier Implantatkörper und Implantatabutment bei dentalen
implantaire des systèmes d'implants dentaires (ISO Implantatsystemen (ISO 22683:2022)
22683:2022)
This European Standard was approved by CEN on 19 May 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22683:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 22683:2022) 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 2022.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 22683:2022 has been approved by CEN as EN ISO 22683:2022 without any modification.

INTERNATIONAL ISO
STANDARD 22683
First edition
2022-05
Dentistry — Rotational adaptability
test between implant body and
implant abutment in dental implant
systems
Médecine bucco-dentaire — Essai d'évaluation de la liberté
rotationnelle entre le corps d'implant et le pilier implantaire des
systèmes d'implants dentaires
Reference number
ISO 22683:2022(E)
ISO 22683:2022(E)
© ISO 2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 22683:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods . 2
4.1 General . 2
4.2 Apparatus . 2
4.3 Sampling . 2
4.4 Procedure . 3
5 Test report . 3
Bibliography . 5
iii
ISO 22683:2022(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
...