SIST EN ISO 10451:2002
(Main)Dental implant systems - Contents of technical file (ISO 10451:2002)
Dental implant systems - Contents of technical file (ISO 10451:2002)
Dentalimplantatsysteme - Inhalt der Technischen Dokumentation (ISO 10451:2002)
In dieser Internationalen Norm werden die Anforderungen an den Inhalt der technischen Dokumentation festgelegt, die erstellt wird, um die Erfüllung der Zulassungsanforderungen für ein Dentalimplantat und jedes vorgefertigte Teil davon nachzuweisen, und das nach dem zahnärztlichen Eingriff im Mund verbleibt.
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.
Systemes d'implants dentaires - Contenu du dossier technique (ISO 10541:2002)
Sistem zobnih vsadkov (implantati) - Vsebina tehnične mape (ISO 1074:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10451:2002
01-november-2002
6LVWHP]REQLKYVDGNRY LPSODQWDWL 9VHELQDWHKQLþQHPDSH ,62
Dental implant systems - Contents of technical file (ISO 10451:2002)
Dentalimplantatsysteme - Inhalt der Technischen Dokumentation (ISO 10451:2002)
Systemes d'implants dentaires - Contenu du dossier technique (ISO 10541:2002)
Ta slovenski standard je istoveten z: EN ISO 10451:2002
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 10451:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10451:2002
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SIST EN ISO 10451:2002
EUROPEAN STANDARD
EN ISO 10451
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2002
ICS 11.060.10
English version
Dental implant systems - Contents of technical file (ISO
10451:2002)
Systèmes d'implants dentaires - Contenu du dossier Dentalimplantatsysteme - Inhalt der Technischen
technique (ISO 10541:2002) Dokumentation (ISO 10451:2002)
This European Standard was approved by CEN on 15 February 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10451:2002 E
worldwide for CEN national Members.
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SIST EN ISO 10451:2002
EN ISO 10451:2002 (E)
CORRECTED 2002-04-17
Foreword
This document (ISO 10451:2002) 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 August 2002, and conflicting national
standards shall be withdrawn at the latest by August 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,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the
United Kingdom.
Endorsement notice
The text of the International Standard ISO 10451:2002 has been approved by CEN as a
European Standard without any modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
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SIST EN ISO 10451:2002
EN ISO 10451:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 1942-1 1989 Dental vocabulary – Part 1: General EN 21942-1 1991
and clinical terms
ISO 7405 1997 Dentistry – Preclinical evaluation of EN ISO 7405 1997
biocompatibility of medical devices
used in dentistry – Test methods for
dental materials
ISO 8601 1988 Data elements and interchange EN 28601 1992
formats – Information interchange –
Representation of dates and times
(including technical corrigendum
1:1991)
ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices – Part 1: Evaluation and
testing
ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
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SIST EN ISO 10451:2002
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SIST EN ISO 10451:2002
INTERNATIONAL ISO
STANDARD 10451
First edition
2002-02-15
Dental implant systems — Contents of
technical file
Systèmes d'implants dentaires — Contenu du dossier technique
Reference number
ISO 10451:2002(E)
©
ISO 2002
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SIST EN ISO 10451:2002
ISO 10451:2002(E)
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ii © ISO 2002 – All rights reserved
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SIST EN ISO 10451:2002
ISO 10451:2002(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references.1
3 Terms and definitions .1
4 Requirements.2
4.1 General.2
4.2 Intended use.2
4.3 Design characteristics .2
4.4 Properties of the constituent materials.2
4.5 Properties of the final product .4
4.6 Manufacturing process .4
4.7 Quality control of the implant manufacturing process.4
4.8 Control of infection and microbial contamination .4
4.9 Risk assessment.4
4.10 Clinical evaluation .5
4.11 Packaging.5
4.12 Label.5
4.13 Instructions for use .6
Bibliography.7
© ISO 2002 – All rights reserved iii
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SIST EN ISO 10451:2002
ISO 10451:2002(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 3.
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 International Standard 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 first edition cancels and replaces ISO/TR 10451:1991, which has been technically revised.
iv © ISO 2002 – All rights reserved
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SIST EN ISO 10451:2002
ISO 10451:2002(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.
© ISO 2002 – All rights reserved v
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SIST EN ISO 10451:2002
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SIST EN ISO 10451:2002
INTERNATIONAL STANDARD ISO 10451:2002(E)
Dental implant systems — Contents of technical file
1 Scope
This International Standard specifies requirements for the contents of a te
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