EN ISO 10451:2010

SLOVENSKI STANDARD
01-oktober-2010
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SIST EN ISO 10451:2002
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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 document, the terms and definitions given in ISO 1942 and the following apply.
3.1
coating
layer of material used to cover or partially cover a surface of an implant or part of an implant system
3.2
dental implant system
device that consists of integrated components including the ancillary instruments and specific equipment
necessary for the clinical and laboratory preparation and placement of the implant, and for the construction
and insertion of the dependent prosthesis
3.3
technical file
documentation provided by the manufacturer containing the basic available information on a device or
indicating its location
3.4
water sorption
gain in water content, per volume, of an initially dry specimen after immersion in water for a given time
2 © ISO 2010 – All rights reserved

ISO 10451:2010(E)
4 Requirements
4.1 General
A technical file of a dental implant system shall include at least the contents described in 4.2 to 4.15.
Documentation may contain data from the scientific literature as well as from specifically performed tests. If
information on more than one property can be obtained from a single test, it is not necessary to conduct
separate tests for each property.
4.2 Intended use
The intended use shall be stated. Device specific indications and contra-indications shall be given.
4.3 Design characteristics
The following information on the design characteristics shall be provided:
a) Design justification: justification for the specific design shall be given.
b) Dimensions: technical drawings showing the dimensions and their tolerances shall be provided. It is
recommended that tolerances be stated in accordance with ISO 129-1 and ISO 14405-2.
c) Surface finish: a description of the required surface finish, its characterization and the test method(s)
used for characterization shall be given.
4.4 Properties of the constituent materials
The following information on the properties of the constituent materials and the test methods used to establish
these properties shall be provided where appropriate:
a) Chemical properties, including electrochemical properties:
1) chemical composition, to a sum of
...