ISO/FDIS 13504
(Main)Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
General Information
- Abstract
This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. This document does not apply to devices used for indirect contact with the human body, including the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
- Status
- Not Published
- Technical Committee
- ISO/TC 106/SC 4 - Dental instruments
- Drafting Committee
- ISO/TC 106/SC 4/WG 13 - Implant instruments
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 23-Jul-2026
- Completion Date
- 23-Jul-2026
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ISO/FDIS 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
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ISO/FDIS 13504 - Médecine bucco-dentaire — Exigences générales relatives aux instruments et aux accessoires connexes utilisés en implantologie dentaire
Overview
ISO/FDIS 13504:2026 – Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment provides internationally recognized guidelines for the manufacture and control of dental instruments and accessories specifically designed for dental implant procedures. Published by the International Organization for Standardization (ISO), this standard applies to all instruments used directly in the placement of dental implants, whether single-use or reusable, and regardless of whether they are manually operated or connected to a power-driven system.
It addresses comprehensive safety requirements, including device classification, intended performance, performance attributes, material selection, manufacturing, sterilization, and the provision of information by manufacturers. The standard does not apply to the dental implants themselves, their directly connected components, or the systems used for indirect patient contact.
Key Topics
Device Classification:
Instruments and accessories are categorized based on:- Type of operation (manual or motor-driven)
- Main tissue contact (hard tissue, soft tissue, or no direct tissue contact)
- Reprocessing requirements (reusable or single-use)
Intended Performance:
Manufacturers must document and verify the functional and operational characteristics of dental implant instruments, ensuring safety and efficacy under intended use conditions.Performance Attributes:
This includes assessment of physical, mechanical, and chemical properties, as well as resistance to wear, ease of cleaning, and suitability for repeated sterilization. Requirements also cover dimensional tolerances, contamination risk, biocompatibility, and usability.Material Selection:
Materials must be selected in accordance with requirements and clarified in the standard’s normative annex, emphasizing long-term clinical safety and biological compatibility.Performance Evaluation:
Pre-clinical and, if necessary, clinical evaluation of the instruments is required to demonstrate intended performance and safety, with reference to ISO 14971 for risk management and ISO 14155 for clinical investigations.Manufacturing and Documentation:
Manufacturers are expected to maintain comprehensive technical documentation addressing design, classification, manufacturing processes, performance evaluations, and all information necessary to support safe use.Sterilization and Reprocessing:
The standard establishes requirements for products supplied both sterile and non-sterile. Sterilization methods should comply with relevant ISO standards for health care product sterilization.Labelling and Instructions:
Manufacturers must clearly label products with critical information including manufacturer details, lot or serial numbers, size or depth indicators, and usage instructions, using ISO-compliant symbols and terms where applicable.
Applications
ISO/FDIS 13504:2026 is crucial for a wide range of stakeholders in dentistry and medical device manufacturing, including:
Dental Instrument Manufacturers:
Ensures global harmonization of safety and performance requirements for dental implant procedure instruments.Regulatory Bodies:
Provides a framework for compliance assessment and regulatory approval of dental implant instruments and accessories.Dental Professionals and Clinics:
Enhances clinical safety, reliability, and traceability of tools used in dental implant placement, supporting high standards of patient care.Quality Managers:
Offers a reference to implement or improve quality management systems for dental device production, with particular relevance to ISO 13485 alignment.
Related Standards
For comprehensive compliance and optimal quality, stakeholders should also consider the following related standards:
- ISO 13485 – Quality management systems for medical devices
- ISO 14971 – Application of risk management to medical devices
- ISO 14155 – Clinical investigation of medical devices for human subjects
- ISO 21850-1/2 – Materials for dental instruments
- ISO 11135, ISO 11137-1, ISO 17665 – Sterilization of health care products
- ISO 15223-1 – Symbols for labeling medical devices
- ISO 1942, ISO 16443 – Dentistry vocabularies
Implementing ISO/FDIS 13504:2026 supports safer, high-quality dental implant procedures and facilitates international market access for manufacturers of dental instruments and related accessories.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 28-Oct-2023
- Effective Date
- 23-Sep-2023
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ISO/FDIS 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
REDLINE ISO/FDIS 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
ISO/FDIS 13504 - Médecine bucco-dentaire — Exigences générales relatives aux instruments et aux accessoires connexes utilisés en implantologie dentaire
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Frequently Asked Questions
ISO/FDIS 13504 is a draft published by the International Organization for Standardization (ISO). Its full title is "Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment". This standard covers: This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. This document does not apply to devices used for indirect contact with the human body, including the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. This document does not apply to devices used for indirect contact with the human body, including the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
ISO/FDIS 13504 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/FDIS 13504 has the following relationships with other standards: It is inter standard links to FprEN ISO 13504, ISO/TS 20432:2022, ISO 13504:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO/FDIS 13504 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/TC 106/SC 4
Dentistry — General requirements
Secretariat: DIN
for instruments and related
Voting begins on:
accessories used in dental implant
2026-07-23
placement and treatment
Voting terminates on:
2026-09-17
Médecine bucco-dentaire — Exigences générales relatives aux
instruments et aux accessoires connexes utilisés en implantologie
dentaire
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
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
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 Intended usage (application) . .2
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 .4
9 Manufacturing . 4
9.1 General .4
9.2 Technical documentation .4
10 Reprocessing . 4
10.1 Products supplied sterile .4
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 .5
11.3 Labelling on the package .5
11.4 Instructions for use .6
Annex A (normative) Acceptable materials for the manufacturing of instruments and
accessories used in dental implant placement and treatment . 7
Bibliography . 9
iii
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 document 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 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 4, Dental
instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 13504:2012), which has been technically
revised.
The main changes are as follows:
— normative references were updated to include all ISO documents referenced within this document;
— terms 3.1, 3.3.2, 3.3.3 and 3.3.4 were deleted;
— Clause 7 was revised to direct material selection to be in accordance with Annex A;
— reprocessing information was adapted in 10.3;
— Tables A.1, A.2 and A.3 were replaced with a reference to ISO 21850-1;
— Annex B was removed 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
Introduction
The use of dental implants is increasing throughout the world. Due to new and improved applications of
dental implants, the need for better instruments and related accessories for placing dental implants and the
further manipulation of connecting parts in the craniofacial area is also growing.
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 should be mitigated.
However, long-term clinical experience of the use of the materials referred to in this document has shown that
an acceptable level of biological response can be expected when they are used in appropriate applications
and when instruments are manufactured under appropriate design considerations and processes.
v
FINAL DRAFT International Standard ISO/FDIS 13504:2026(en)
Dentistry — General requirements for instruments and
related accessories used in dental implant placement and
treatment
1 Scope
This document specifies general requirements for the manufacture of instruments and related accessories
used in the placement of dental implants.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or
connected to a power-driven system.
This document does not apply to devices used for indirect contact with the human body, including the power-
driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
With regard to safety, this document gives requirements for classification, intended performance,
performance attributes, material selection, performance evaluation, manufacture, sterilization and
information to be supplied by the manufacturer.
2 Normative references
The following documents are referred to in the text in such a way that some or all their content constitutes
requirements 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 1942, Dentistry — Vocabulary
ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications
ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
ISO 5832-3,
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Secretariat: DIN
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Date: 2025-12-052026-07-08
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Dentistry — General requirements for instruments and related
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accessories used in dental implant placement and treatment
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Médecine bucco-dentaire — Exigences générales relatives aux instruments et aux accessoires connexes utilisés
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
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may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either
Formatted: Left: 1.5 cm, Right: 1.5 cm, Bottom: 1 cm,
ISO at the address below or ISO’s member body in the country of the requester.
Header distance from edge: 1.27 cm, Footer distance
from edge: 0.5 cm
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Formatted: French (Switzerland)
Website: www.iso.orgwww.iso.org
Formatted: English (United Kingdom)
Published in Switzerland
Formatted: English (United Kingdom)
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pt, Line spacing: single
ii © ISO #### 2026 – All rights reserved
ii
ISO/DISFDIS 13504.2:2025:2026(en)
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Contents
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Foreword . v
Adjust space between Asian text and numbers
Introduction . vi
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 . 4
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 . 5
11.3 Labelling on the package . 6
11.4 Instructions for use . 6
Annex A (normative) Acceptable materials for the manufacturing of instruments and
accessories used in dental implant placement and treatment . 8
Bibliography . 10
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
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3 Terms and definitions . 2
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4 Classification. 3
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4.1 Intended usage (application) . 3 Tab stops: Not at 17.2 cm
4.2 Tissue contact. 3
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4.3 Reprocessing . 3
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5 Intended performance . 3
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iii
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6 Performance attributes . 4
7 Material selection . 4
8 Performance evaluation . 5
8.1 General. 5
8.2 Pre-clinical evaluation . 5
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 . 6
10.3 Reprocessing information . 6
11 Information to be supplied by the manufacturer . 6
11.1 General. 6
11.2 Marking on instruments . 6
11.3 Labelling on the package . 6
11.4 Instructions for use . 7
Annex A (normative) Materials found acceptable for instrument manufacture . 8
A.1 Materials . 8
A.2 Stainless steels . 8
A.3 Titanium and titanium alloys . 8
A.4 Ceramic materials . 8
A.5 Hard metals . 8
A.6 Coatings (only additive procedures) . 9
A.7 Surface treatment . 9
A.8 Polymers . 9
Bibliography . 11
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iv © ISO #### 2026 – All rights reserved
iv
ISO/DISFDIS 13504.2:2025:2026(en)
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Foreword
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ISO (the International Organization for Standardization) is a worldwide federation of national standards
Formatted: Adjust space between Latin and Asian text,
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through Adjust space between Asian text and numbers
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 document 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).
Formatted: English (United Kingdom)
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 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.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.
Formatted: English (United Kingdom)
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
Formatted: Adjust space between Latin and Asian text,
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Adjust space between Asian text and numbers
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
This document was prepared by Technical Committee ISO/TC 106 Dentistry, Subcommittee SC 4, Dental
instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee Formatted: Default Paragraph Font
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
Formatted: Adjust space between Latin and Asian text,
(Vienna Agreement).
Adjust space between Asian text and numbers, Tab
stops: Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm +
This second edition cancels and replaces the first edition (ISO 13504:2012), which has been technically
3.5 cm + 4.2 cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
revised.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
The main changes are as follows:
Formatted: Default Paragraph Font
— — normative references were updated to include all ISO documents referenced within this document;
Formatted: Default Paragraph Font
— — terms 3.1,3.1, 3.3.2, 3.3.3 and 3.3.4 were deleted;
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
— — Clause 7Clause 7 was revised to direct material selection to be in accordance with Annex A;Annex A;
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Adjust space between Asian text and numbers
— — reprocessing information was adapted in 10.3;10.3;
Formatted: Font: 10 pt
— — Tables A.1, A.2Tables A.1, A.2 and A.3 were replaced with a reference to ISO 21850-1;
Formatted: Font: 10 pt
— — Annex B was removed since this information is captured in ISO 21850-1. Formatted: FooterCentered, Left, Space Before: 0 pt,
Tab stops: Not at 17.2 cm
Any feedback or questions on this document should be directed to the user’s national standards body. A
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complete listing of these bodies can be found at www.iso.org/members.htmlwww.iso.org/members.html.
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After: 0 pt, Tab stops: Not at 17.2 cm
v
Formatted: Font: Bold
Formatted: HeaderCentered
Introduction
The use of dental implants is increasing throughout the world. Due to new and improved applications of dental
implants, the need for better instruments and related accessories for placing dental implants and the further
manipulation of connecting parts in the craniofacial area is also growing.
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 should be mitigated.
However, long-term clinical experience of the use of the materials referred to in this document has shown that
an acceptable level of biological response can be expected when they are used in appropriate applications and
when instruments are manufactured under appropriate design considerations and processes.
Formatted: Font: 10 pt
Formatted: Font: 10 pt
Formatted: Font: 11 pt
Formatted: FooterPageRomanNumber, Space After: 0
pt, Line spacing: single
vi © ISO #### 2026 – All rights reserved
vi
DRAFT International Standard ISO/DIS 13504.2:2025(en)
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Dentistry — General requirements for instruments and related
Formatted
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accessories used in dental implant placement and treatment
Formatted
...
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...
1 Scope
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This document specifies general requirements for the manufacture of instruments and related accessories
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used in the placement of dental implants.
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It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or Formatted
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connected to a power-driven system.
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This document does not apply to devices used for indirect contact with the human body, including the power-
driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
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With regard to safety, this document gives requirements for classification, intended performance,
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performance attributes, material selection, performance evaluation, manufacture, sterilization and .
information to be supplied by the manufacturer.
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2 Normative references
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requirements of this document. For dated references, only the edition cited applies. For undated references,
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ISO 1043-1, Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics
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ISO 1942, Dentistry — Vocabulary
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ISO 2768--1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
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tolerance indications
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ISO 5832--2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
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ISO 5832--3, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium
alloy
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ISO 11135, Sterilization of health care products — Ethylene oxide
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ISO 11137--1, Sterilization of health care products — Radiation — Part 1: Requirements for the development,
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validation and routine control of a sterilization process for medical devices
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ISO 14971, Medical devices — Application of risk management to medical devices
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ISO 15223--1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
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ISO 16443, Dentistry — Vocabulary for dental implants systems and related procedure .
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ISO 17664--1, Processing of health care products — Information to be provided by the medical device
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manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
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ISO 17664--2, Processing of health care products — Information to be provided by the medical device
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PROJET FINAL
Norme
internationale
ISO/TC 106/SC 4
Médecine bucco-dentaire —
Secrétariat: DIN
Exigences générales relatives aux
Début de vote:
instruments et aux accessoires
2026-07-23
connexes utilisés en implantologie
Vote clos le:
dentaire
2026-09-17
Dentistry — General requirements for instruments and related
accessories used in dental implant placement and treatment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 106/SC 4
Médecine bucco-dentaire —
Secrétariat: DIN
Exigences générales relatives aux
Début de vote:
instruments et aux accessoires
2026-07-23
connexes utilisés en implantologie
Vote clos le:
dentaire
2026-09-17
Dentistry — General requirements for instruments and related
accessories used in dental implant placement and treatment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
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Web: www.iso.org
Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Classification . 2
4.1 Utilisation prévue (application) .2
4.2 Contact avec les tissus .3
4.3 Retraitement.3
5 Performances prévues . 3
6 Caractéristiques de performances . 3
7 Choix des matériaux . 4
8 Évaluation des performances . 4
8.1 Généralités .4
8.2 Évaluation préclinique .4
8.3 Évaluation clinique .4
9 Fabrication . 4
9.1 Généralités .4
9.2 Documentation technique .4
10 Retraitement . 4
10.1 Produits fournis stériles .4
10.2 Produits fournis non stériles .5
10.3 Informations relatives au retraitement .5
11 Informations à fournir par le fabricant . 5
11.1 Généralités .5
11.2 Marquage sur les instruments .5
11.3 Étiquetage sur l’emballage .5
11.4 Notice d'utilisation .6
Annexe A (normative) Matériaux acceptables pour la fabrication des instruments et accessoires
utilisés en implantologie dentaire . 7
Bibliographie . 9
iii
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L'ISO attire l'attention sur le fait que la mise en application du présent document peut entraîner l'utilisation
d'un ou de plusieurs brevets. L'ISO ne prend pas position quant à la preuve, à la validité et à l'applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l'ISO n’avait pas
reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d'avertir les responsables de la mise en application du présent document que des informations
plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à l'adresse
www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou partie de
tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l'intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 106, Médecine bucco-dentaire, sous-comité
SC 4, Instruments dentaires, en collaboration avec le comité technique CEN/TC 55, Médecine bucco-dentaire,
du Comité européen de normalisation (CEN), conformément à l'Accord de coopération technique entre l'ISO
et le CEN (Accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 13504:2012), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— les références normatives ont été mises à jour pour inclure tous les documents ISO auxquels il est fait
référence dans le présent document;
— les articles terminologiques 3.1, 3.3.2, 3.3.3 et 3.3.4 ont été supprimés;
— l'Article 7 a été révisé pour que le choix direct des matériaux soit conforme à l'Annexe A;
— les informations relatives au retraitement ont été adaptées au 10.3;
— les Tableaux A.1, A.2 et A.3 ont été remplacés par une référence à l'ISO 21850-1;
— l'Annexe B a été supprimée car ces informations figurent dans l'ISO 21850-1.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l'adresse www.iso.org/members.html.
iv
Introduction
L’utilisation des implants dentaires est en constante augmentation partout dans le monde. Compte tenu des
applications nouvelles et améliorées de l’implantologie dentaire, il est de plus en plus nécessaire de disposer
d’instruments et d’accessoires connexes de meilleure qualité pour la pose d’implants dentaires et pour les
manipulations ultérieures des éléments de connexion dans la région cranio-faciale.
Les matériaux constitutifs des instruments utilisés dans le cadre des procédures d’implantologie se sont
révélés être bien tolérés. Les réactions négatives éventuelles ne peuvent pas être totalement écartées, mais
il convient de les atténuer.
Toutefois, l’expérience clinique acquise de longue date concernant l’utilisation des matériaux auxquels il est
fait référence dans le présent document a démontré qu’un niveau acceptable de réponse biologique peut être
attendu lorsque ces matériaux sont utilisés dans des applications appropriées et lorsque la conception et les
processus de fabrication des instruments sont appropriés.
v
PROJET FINAL Norme internationale ISO/FDIS 13504:2026(fr)
Médecine bucco-dentaire — Exigences générales relatives
aux instruments et aux accessoires connexes utilisés en
implantologie dentaire
1 Domaine d'application
Le présent document spécifie les exigences générales pour la fabrication d’instruments et accessoires
connexes utilisés pour la pose d'implants dentaires.
Il est applicable aux instruments à usage unique et aux instruments réutilisables, qu’ils soient à commande
manuelle ou raccordés à des systèmes commandés par moteur.
Le présent document ne s’applique pas aux dispositifs utilisés pour le contact indirect avec le corps humain,
y compris le système commandé par moteur proprement dit, ni à l’implant dentaire ou aux parties destinées
à y être raccordées.
En ce qui concerne la sécurité, le présent document fournit des exigences relatives à la classification, aux
performances prévues, aux caractéristiques de performance, au choix du matériau, à l’évaluation des
performances, à la fabrication, à la stérilisation, et aux informations à fournir par le fabricant.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu'ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l'édition citée s'applique. Pour
les références non datées, la dernière édition du document de référence s'applique (y compris les éventuels
amendements).
ISO 1942, Médecine bucco-dentaire — Vocabulaire
ISO 2768-1, Tolérances générales — Partie 1: Tolérances pour dimensions linéaires et angulaires non affectées
de tolérances individuelles
ISO 5832-2, Implants chirurgicaux — Matériaux métalliques — Partie 2: Titane non allié
ISO 5832-3, Implants chirurgicaux — Matériaux mét
...