EN ISO 14727:1998

SLOVENSKI STANDARD
01-januar-2000
Dental implants - Prefabricated parts connecting suprastructures to dental
implants - Contents of technical file (ISO 14727:1998)
Dental implants - Prefabricated parts connecting suprastructures to dental implants -
Contents of technical file (ISO 14727:1998)
Dentalimplantate - Vorgefertigte Teile zur Verbindung von Suprastrukturen mit
Dentalimplantaten - Inhalt der technischen Dokumentation (ISO 14727:1998)
Implants dentaires - Organes préfabriqués destinés a relier les suprastructures aux
implants dentaires - Contenu du dossier technique (ISO 14727:1998)
Ta slovenski standard je istoveten z: EN ISO 14727:1998
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL ISO
STANDARD 14727
First edition
1998-10-01
Dental implants — Prefabricated parts
connecting suprastructures to dental
implants — Contents of technical file
Implants dentaires — Organes préfabriqués destinés à relier les
suprastructures aux implants dentaires — Contenu du dossier technique
A
Reference number
ISO 14727:1998(E)
ISO 14727:1998(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.
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.
International Standard ISO 14727 was prepared by Technical Committee
ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.
©  ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
©
ISO ISO 14727:1998(E)
Introduction
The functions of the masticatory system can be restored with implant-
retained prostheses. Such prosthetic suprastructures are joined to the
dental implants by "connecting parts" that provide an appropriate means of
fixation.
Quality system requirements as laid down in ISO 9001 and ISO 13485 call
for a file containing documents defining the product specifications for each
type/model of medical device.
This International Standard specifies particular technical information to be
contained in such a file for prefabricated parts connecting dental
suprastructures to dental implants, termed a technical file for this purpose.
iii
INTERNATIONAL STANDARD  © ISO ISO 14727:1998(E)
Dental implants — Prefabricated parts connecting suprastructures
to dental implants — Contents of technical file
1 Scope
This International Standard specifies requirements for the contents of a technical file for prefabricated parts
connecting a dental suprastructure to a transgingival dental implant. It applies to all parts providing functional load
transfer from a suprastructure to a dental implant, excluding custom-made devices for the same purpose.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 1942-1, Dental vocabulary — Part 1: General and clinical terms.
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Guidance on selection of tests.
ISO 14155, Clinical investigation of medical devices .
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 1942-1 and ISO 10993-1
together with the following apply.
3.1
dental implant
device specially designed to be placed surgically within or on the mandibular or maxillary bone as a means of
providing support and retention to the displacement of a dental prosthesis
NOTE 1 A dental implant can be either transgingival (with part of the implant emerging from the gingiva for direct abutment),
or fully embedded under the gingiva (intended only to support a removable prosthesis).
[ISO 1942-1]
NOTE 2 In the case where the implant itself consists of two parts according to the manufacturer’s definition, the
transmucosal part, which is inserted by a surgical procedure, is part of the implant and not covered by this International
Standard.
3.2
suprastructure
custom-made device attached to a dental implant
© ISO
ISO 14727:1998(E)
3.3
prefabricated part:
part, other than custom-made parts, used to connect a suprastructure to a dental implant
3.4
technical file
documentation supplied by the manufacturer containing the available basic information on a device
4 Requirements
4.1 General
A technical file of a prefabricated part connecting an implant to a prosthesis shall contain at least the information
described in 4.2 to 4.13.
4.2 Intended use
The intended use of the prefabricated part shall be stated. The intended-use statement shall comprise a
specification of the implant(s) by brand name or generic description for use with which the connecting part is
intended.
4.3 Biological properties
Results of biological tests of the materials in use shall be available.
Guidance for biological testing is given in ISO 7405 and ISO 10993-1.
Adequate bioresponse properties are assumed for any material complying with the compositional requirements
given in an appropriate International Standard specification for a surgical implant material, where a biocompatibility
statement appears in that standard (e.g. ISO 5832-2, ISO 5832-3 and ISO 6474).
In many cases
...