prEN ISO 10451
(Main)Dentistry - Contents of technical file for dental implant systems (ISO/DIS 10451:2024)
Dentistry - Contents of technical file for dental implant systems (ISO/DIS 10451:2024)
Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO/DIS 10451:2024)
Médecine bucco-dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO/DIS 10451:2024)
Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov) (ISO/DIS 10451:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2025
Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov)
(ISO/DIS 10451:2024)
Dentistry - Contents of technical file for dental implant systems (ISO/DIS 10451:2024)
Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme
(ISO/DIS 10451:2024)
Médecine bucco-dentaire - Contenu du dossier technique pour les systèmes d'implants
dentaires (ISO/DIS 10451:2024)
Ta slovenski standard je istoveten z: prEN ISO 10451
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 10451
ISO/TC 106/SC 8
Dentistry — Contents of technical
Secretariat: ANSI
file for dental implant systems
Voting begins on:
Médecine bucco-dentaire — Contenu du dossier technique pour
2024-11-07
les systèmes d'implants dentaires
Voting terminates on:
ICS: 11.060.15 2025-01-30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10451:2024(en)
DRAFT
ISO/DIS 10451:2024(en)
International
Standard
ISO/DIS 10451
ISO/TC 106/SC 8
Dentistry — Contents of technical
Secretariat: ANSI
file for dental implant systems
Voting begins on:
Médecine bucco-dentaire — Contenu du dossier technique pour
les systèmes d'implants dentaires
Voting terminates on:
ICS: 11.060.15
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10451:2024(en)
ii
ISO/DIS 10451:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Technical file content and requirements. 3
4.1 Device description and specification.4
4.2 Risk analysis .5
4.3 Infection and microbial contamination .5
4.4 Manufacturing information .5
4.5 Verification and validation activities .6
4.6 Clinical evaluation and Clinical investigation .7
4.7 Information supplied by the manufacturer .8
4.8 Post Market Surveillance .9
4.9 Essential Principles of safety and performance checklist .9
4.10 Declaration of conformity .9
Annex A (informative) List of identified hazards for dental implants .10
Bibliography .12
iii
ISO/DIS 10451:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 8, Dental
implants.
This third edition cancels and replaces the second edition (ISO 10451:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Rework of the content for the Technical File considering the new European Medical Device Regulation,
— Addition of Annex A describing a list of Hazards related to Dental Implants.
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/DIS 10451:2024(en)
Introduction
Legal/regulatory requirements on the documentation of the design, manufacture and performance of
dental implants are developing in various ways in different countries and international regions. As the
dental implant industry is already active on a global basis, and is becoming more so, concern is growing as
to the need for international and mutually recognized standards for documentation of the design and the
performance of such devices.
v
DRAFT International Standard ISO/DIS 10451:2024(en)
Dentistry — Contents of technical file for dental implant systems
1 Scope
This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of
regulatory requirements for an endosseous dental implant that may include:
— implant body,
— implant abutment,
— abutment screw,
— implant connecting part
— implant connecting part screw
— prosthetic screw,
— implant cover screw,
— transmucosal healing component.
This document includes requirements for intended use and performance, design attributes, components,
biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information
supplied by the manufacturer.
The following devices are not included within the scope of this document:
— Dental implant incorporating animal or human components or bioactive characteristics,
— Custom-made devices that have no pre-fabricated connection,
— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,
— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,
— Specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and
augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane
materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental
implant system. These instruments require a separate technical file.
NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for
Personalized Medical Devices.
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/DIS 10451:2024(en)
ISO 3950, Dentistry — Designation system for teeth and areas of the oral cavity
ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 10271, Dentistry — Corrosion test methods for metallic materials
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
ISO 10993-17, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical
device constituents
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation
and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
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