SIST EN ISO 10451:2010

Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.

Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO 10451:2010)

Diese Internationale Norm legt Anforderungen an den Inhalt der Technischen Dokumentation fest, die erstellt
wird, um die Erfüllung der Zulassungsanforderungen für ein Dentalimplantat und alle dazugehörigen
vorgefertigten Teile nachzuweisen, die nach dem zahnärztlichen Eingriff im Mund verbleiben.
Diese Internationale Norm gilt nicht für Instrumente und andere Teile, die speziell für ein Dentalimplantatsystem
hergestellt wurden, aber nicht im Mund verbleiben. Trotzdem kann die Dokumentation zu diesen
Komponenten in die Technische Dokumentation eingefügt werden.

Art dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO 10451:2010)

L'ISO 10451:2010 spécifie les exigences relatives au contenu du dossier technique afin de démontrer que tout implant dentaire, y compris ses constituants préfabriqués destinés à rester dans la bouche après intervention chirurgicale, satisfait aux exigences réglementaires.

Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov) (ISO 10451:2010)

Ta mednarodni standard določa zahteve za vsebino tehnične mape, ki prikazuje izpolnjevanje regulativnih zahtev za zobni vsadek in njegove tovarniško izdelane dele, ki po posegu ostanejo v ustih. Ta mednarodni standard ne velja za instrumente in druge dele, ki so narejeni posebej za sistem zobnih vsadkov, vendar ne ostanejo v ustih. Dokumentacija v zvezi s temi sestavnimi deli pa se lahko vključi v tehnično mapo.

General Information

• Status: Published
• Public Enquiry End Date: 19-Jun-2009
• Publication Date: 14-Sep-2010
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-Aug-2010
• Due Date: 25-Oct-2010
• Completion Date: 15-Sep-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 10451:2010 - Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

Relations

• Replaces: SIST EN ISO 10451:2002 - Dental implant systems - Contents of technical file (ISO 10451:2002)
• Effective Date: 01-Oct-2010
• Revised: kSIST FprEN ISO 10451:2025 - Dentistry - Contents of a technical file for dental implant systems (ISO/FDIS 10451:2025)
• Effective Date: 28-Jan-2023

Overview

EN ISO 10451:2010 (ISO 10451:2010) defines the minimum content of a technical file to demonstrate conformity with regulatory requirements for dental implant systems and any prefabricated parts that remain in the mouth after surgery. Prepared under ISO/TC 106 and endorsed by CEN, this standard applies to manufacturers who must document design, materials, testing, sterilization and clinical evidence for implants intended for long‑term intraoral use. It does not apply to surgical instruments that do not remain in the mouth (though their documentation may be included).

Key topics and requirements

The standard specifies the technical documentation items that should be included in the technical file. Major requirements include:

• Intended use: clear statement of device indications and contraindications.
• Design characteristics: design justification, technical drawings with dimensions and tolerances (recommended per ISO 129‑1 and ISO 14405‑2), and surface‑finish description and test methods.
• Constituent materials: chemical, physical and mechanical properties (e.g., composition to 100 %, impurities, corrosion/electrochemical data for metals, water sorption for polymers, flexural strength for ceramics/polymers).
• Final product testing: fatigue testing (ISO 14801, where applicable), coating adhesion, degradation testing (ISO 10993‑9), and biological evaluation results.
• Risk assessment: documented risk analysis complying with ISO 14971.
• Infection control and sterilization: delivery state (sterile/non‑sterile), validated sterilization method and validation references (ISO 11135, ISO 11137, ISO 14937, ISO 17664, ISO 17665‑1 as applicable).
• Biological and clinical evaluation: biocompatibility testing (ISO 10993 series, ISO 7405) and documented clinical evaluation; clinical investigations recommended to follow ISO 14155.
• Manufacturing process: description of production steps, controls to ensure design attributes, and analysis of residual manufacturing materials.
• Traceability and references: links to previous device generations or similar marketed devices if used for development/evaluation.

Applications and who uses it

EN ISO 10451 is primarily used by:

• Manufacturers of dental implants and prefabricated intraoral components (for preparing regulatory technical files).
• Regulatory affairs teams assembling documentation for market authorization and CE marking.
• Notified bodies and regulatory authorities assessing conformity and reviewing technical documentation.
• Design engineers, QA/RA managers and testing laboratories to plan required tests and evidence.
• Clinical researchers preparing clinical evaluation reports.

Related standards

Key referenced documents include: ISO 10993‑1 / ‑7 / ‑9, ISO 14801, ISO 14971, ISO 11135 / ISO 11137, ISO 11607, ISO 17664 / ISO 17665‑1, ISO 14155, ISO 7405, ISO/TS 22911, ISO 129‑1, ISO 14405‑2.

EN ISO 10451:2010 helps ensure consistent, comprehensive technical documentation for dental implant systems - supporting regulatory compliance, risk management, and safe clinical use.

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2010
1DGRPHãþD
SIST EN ISO 10451:2002
=RER]GUDYVWYR9VHELQDWHKQLþQHPDSH]DVLVWHP]REQLKYVDGNRYLPSODQWDWRY
,62
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO
10451:2010)
Art dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO
10451:2010)
Ta slovenski standard je istoveten z: EN ISO 10451:2010
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10451
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2010
ICS 11.060.15
English Version
Dentistry - Contents of technical file for dental implant systems
(ISO 10451:2010)
Médecine bucco-dentaire - Contenu du dossier technique Zahnheilkunde - Inhalt der Technischen Dokumentation für
pour les systèmes d'implants dentaires (ISO 10451:2010) Dentalimplantatsysteme (ISO 10451:2010)
This European Standard was approved by CEN on 26 May 2010.

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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10451:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 10451:2010) 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 2010, and conflicting national standards shall be withdrawn
at the latest by December 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10451:2002.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10451:2010 has been approved by CEN as a EN ISO 10451:2010 without any modification.

INTERNATIONAL ISO
STANDARD 10451
Second edition
2010-06-15
Dentistry — Contents of technical file for
dental implant systems
Médecine bucco-dentaire — Contenu du dossier technique pour les
systèmes d'implants dentaires
Reference number
ISO 10451:2010(E)
©
ISO 2010
ISO 10451:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 10451:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10451 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants.
This second edition cancels and replaces the first edition (ISO 10451:2002) which has been technically
revised.
ISO 10451:2010(E)
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.
iv © ISO 2010 – All rights reserved

INTERNATIONAL STANDARD ISO 10451:2010(E)

Dentistry — Contents of technical file for dental implant
systems
1 Scope
This International Standard specifies requirements for the contents of a technical file to demonstrate the
fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the
mouth after surgery.
This International Standard is not applicable to instruments and other parts specifically made for the dental
implant system but which do not remain in the mouth. However, documentation relating to these components
may be included in the technical file.
2 Normative references
The following referenced documents are indispensable for the application 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 129-1, Technical drawings — Indication of dimensions and tolerances — Part 1: General principles
ISO 1942, Dentistry — Vocabulary
ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO/TS 11135-2, Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application
of ISO 11135-1
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 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 10451:2010(E)
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14405-2, Geometrical product specifications (GPS) — Dimensional tolerancing — Part 2: Dimensions
other than linear sizes
ISO 14801, Dentistry — Implants — Dynamic fatigue test for endosseous dental implants
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO/TS 22911, Dentistry — Preclinical evaluation of dental implant systems — Animal test methods
3 Terms and definitions
For the purposes of this
...