Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2024)

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete Instrumente und Zubehör (ISO/DIS 13504:2024)

Médecine bucco-dentaire - Exigences générales relatives aux instruments et aux accessoires connexes utilisés en implantologie dentaire (ISO/DIS 13504:2024)

L'ISO 13504:2012 spécifie les exigences générales pour la fabrication d'instruments et accessoires connexes pour la pose des implants dentaires et pour les manipulations ultérieures des éléments de raccordement dans la région cranio-faciale.
L'ISO 13504:2012 s'applique aux instruments à usage unique et aux instruments réutilisables, qu'ils soient à commande manuelle ou raccordés à des systèmes commandés par moteur.

Zobozdravstvo - Splošne zahteve za instrumente in pripadajoči pribor, ki se uporablja pri nameščanju in vstavitvi dentalnih vsadkov (implantatov) (ISO/DIS 13504:2024)

General Information

Status
Not Published
Public Enquiry End Date
09-Sep-2024
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
01-Jul-2024
Due Date
18-Nov-2024

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SLOVENSKI STANDARD
01-september-2024
Zobozdravstvo - Splošne zahteve za instrumente in pripadajoči pribor, ki se
uporablja pri nameščanju in vstavitvi dentalnih vsadkov (implantatov) (ISO/DIS
13504:2024)
Dentistry - General requirements for instruments and related accessories used in dental
implant placement and treatment (ISO/DIS 13504:2024)
Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete
Instrumente und Zubehör (ISO/DIS 13504:2024)
Médecine bucco-dentaire - Exigences générales relatives aux instruments et aux
accessoires connexes utilisés en implantologie dentaire (ISO/DIS 13504:2024)
Ta slovenski standard je istoveten z: prEN ISO 13504
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 13504
ISO/TC 106/SC 4
Dentistry — General requirements
Secretariat: DIN
for instruments and related
Voting begins on:
accessories used in dental implant
2024-06-18
placement and treatment
Voting terminates on:
2024-09-10
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie
dentaire
ICS: 11.060.25
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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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 13504:2024(en)
DRAFT
ISO/DIS 13504:2024(en)
International
Standard
ISO/DIS 13504
ISO/TC 106/SC 4
Dentistry — General requirements
Secretariat: DIN
for instruments and related
Voting begins on:
accessories used in dental implant
placement and treatment
Voting terminates on:
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie
dentaire
ICS: 11.060.25
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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 13504:2024(en)
ii
ISO/DIS 13504:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 3
4.1 Intended usage (application) . .3
4.2 Tissue contact .3
4.3 Reprocessing .3
5 Intended performance . 3
6 Performance attributes . 3
7 Material selection . 4
8 Performance evaluation . 4
8.1 General .4
8.2 Pre-clinical evaluation . .4
8.3 Clinical evaluation .5
9 Manufacturing . 5
9.1 General .5
9.2 Technical documentation .5
10 Reprocessing . 5
10.1 Products supplied sterile .5
10.2 Products provided non-sterile .5
10.3 Reprocessing information .5
11 Information to be supplied by the manufacturer . 5
11.1 General .5
11.2 Marking on instruments .6
11.3 Labelling on the package .6
11.4 Instructions for use .6
Annex A (normative) Materials found acceptable for instrument manufacture . 7
Bibliography . 9

iii
ISO/DIS 13504:2024(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 documents 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/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 04, Dental
instruments.
This second edition cancels and replaces the first edition (ISO 13504:2012), which has been technically
revised.
The main changes are as follows:
— Updated normative references to include all ISO documents referenced within this document
— Replaced Tables A.1, A.2, and A.3 with a reference to ISO 21850-1
— Removed Annex B since this information is captured in ISO 21850-1
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 13504:2024(en)
Introduction
The use of dental implants is increasing throughout the world. Due to improved and new applications of
dental implants, the need for better instruments and related accessories to be used in the placement of
dental implants and the further manipulation of connecting parts in the craniofacial area is also growing.
Dental implants need to be approved by local authorities.
However, instruments used in the placement of dental implants are different and need a different approval
procedure. This document is intended to harmonize the approval procedures and to reduce the costs caused
by repeated approval and test procedures in different countries.
Materials present in instruments used in dental implant procedures have proven to be well tolerated.
Potential adverse reactions cannot be totally ruled out, but such reactions are to be mitigated.
However, long-term clinical experience of the use of the materials referred to in this document has shown that
...

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