FprEN ISO 13504
(Main)Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/FDIS 13504:2026)
- 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
- Publication Date
- 17-Dec-2026
- Technical Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 17-Sep-2026
- Completion Date
- 17-Sep-2026
FprEN ISO 13504 is a CEN/ISO draft standard for dentistry that sets general requirements for instruments and related accessories used in dental implant placement and treatment. It is intended for manufacturers, evaluators and buyers who need to specify the intended use, materials, sterilization and manufacturer information for single-use and reusable instruments, whether hand-operated or connected to a power-driven system.
What does FprEN ISO 13504 specify?
FprEN ISO 13504 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and in further manipulation of connecting parts in the craniofacial area. The scope covers single-use and reusable instruments, but excludes the power-driven system itself, the dental implant, and parts intended to connect to the implant.
The document is organized into clauses on scope, normative references, terms and definitions, classification, intended performance, performance attributes, material selection, performance evaluation, manufacturing, reprocessing, and manufacturer information. Annex A is normative and gives acceptable materials for manufacture.
| Annex | What it covers |
|---|---|
| A | Materials found acceptable for instrument manufacture, including stainless steels, titanium, titanium alloys, ceramic materials, hard metals, coatings, surface treatments and example polymers |
What are the key requirements of FprEN ISO 13504?
Classification and intended use
Clause 4 classifies instruments by intended use, tissue contact and reprocessing. FprEN ISO 13504 distinguishes energized or motor-driven instruments from manual instruments, hard-tissue, soft-tissue and no-tissue-contact cases, and multiple-use from single-use products. In practice, the manufacturer has to state what the instrument is for, because that drives evaluation, labeling and reprocessing instructions.
Intended performance and performance attributes
Clause 5 requires the intended performance to be described and documented in terms of function and intended conditions of use. Clause 6 then expands this into the main performance attributes, including material properties, contamination, usability, cleaning, maintenance, effects of sterilization and storage, wear, fit and interconnection of parts, and any fluid leakage or diffusion. If no special dimensional tolerances are stated, the document points to ISO 2768-1 for general drawing tolerances.
Materials and biological evaluation
Clause 7 requires material selection to match the intended purpose and to consider manufacturing, handling, sterilization and storage. Suitability can be shown either by design evaluation or by using materials listed in Annex A. Clause 7 also requires biological evaluation of the final product or representative samples in accordance with ISO 7405 and ISO 10993-1, so material choice is tied to biocompatibility evidence.
Performance evaluation and risk
Clause 8 requires instruments to be evaluated together with the implant system they are meant to support. Safety is demonstrated through pre-clinical evaluation and a risk analysis in accordance with ISO 14971, and clinical evaluation may also be needed. If clinical investigation is carried out, ISO 14155 applies. For reusable instruments, suitability for reprocessing must also be evaluated.
Manufacture, reprocessing and labeling
Clause 9 requires manufacture to match the specified performance attributes and technical documentation to cover Clauses 4 to 8, 10 and 11. Clause 10 sets requirements for sterile and non-sterile products, including validated sterilization processes and reprocessing information in line with ISO 17664. Clause 11 covers marking on instruments, package labeling and instructions for use, including content such as manufacturer identity, lot or serial number, single-use marking where applicable, and sterilization information for sterile products.
What terms does FprEN ISO 13504 define?
- Transient usage - use for less than 60 minutes in any one clinical procedure.
- Surgically invasive device - a device that penetrates the human body through the surface of the body during surgery.
- Instrument used in dental implant placement and treatment - a surgically invasive device used transiently to prepare bone and tissue in the craniofacial region for implant placement and related manipulation.
- Accessory used in dental implant placement and treatment - a non-surgically invasive device used transiently in direct or indirect contact with the human body for those same tasks.
- Stainless steel - steel whose main alloying element is chromium and whose corrosion resistance is the main design feature.
- Austenitic stainless steel - a corrosion-resistant stainless steel that cannot be hardened by heat treatment.
- Martensitic stainless steel - a corrosion-resistant stainless steel that can be hardened by quenching and tempering.
- Precipitation-hardening stainless steel - a corrosion-resistant steel that gains high strength through a final low-temperature heat treatment.
Who uses FprEN ISO 13504?
FprEN ISO 13504 is used by manufacturers of dental implant instruments and related accessories, especially those designing reusable or single-use tools for surgical and clinical use. It is also used by quality and regulatory staff who prepare technical files, manage risk, define labeling and check sterilization or reprocessing claims.
Testing laboratories use it to plan pre-clinical and biological evaluations, and clinicians or procurement teams can use it to compare products on the basis of intended use, material class, sterilization state and labeling. It is also relevant to suppliers of metals, polymers, coatings and surface treatments listed in Annex A.
What changed in FprEN ISO 13504 from the previous edition?
FprEN ISO 13504 replaces ISO 13504:2012 and is technically revised. The stated changes are updated normative references, replacement of Tables A.1, A.2 and A.3 with a reference to ISO 21850-1, and removal of Annex B because that information is now captured in ISO 21850-1.
Which standards are used with FprEN ISO 13504?
| Standard | What it contributes |
|---|---|
| ISO 1942 | Basic dentistry vocabulary used for terms and definitions |
| ISO 14971 | Risk management for medical devices |
| ISO 7405 | Biological evaluation of dental medical devices |
| ISO 10993-1 | Biological evaluation within a risk management process |
| ISO 14155 | Good clinical practice for clinical investigations |
| ISO 15223-1 | Symbols used on labels and package information |
| ISO 17664 | Information for processing resterilizable medical devices |
| ISO 11135 series | Ethylene oxide sterilization validation and routine control |
| ISO 11137 series | Radiation sterilization validation and routine control |
| ISO 17665 series | Moist-heat sterilization validation and routine control |
| ISO 2768-1 | General drawing tolerances when no specific tolerances are given |
| ISO 15510 | Stainless steel designation and chemical composition |
| ISO 5832-2 and ISO 5832-3 | Titanium and titanium alloy material requirements |
| ISO 21850-1 | Acceptable stainless steel compositions for dental instruments |
| ISO 1043-1 | Symbol system for plastics used in Annex A |
What does the FprEN ISO 13504 document contain?
FprEN ISO 13504 contains classification rules, performance and safety requirements, evaluation methods, manufacturing and reprocessing requirements, and the information that has to accompany the product. It also contains Annex A, which lists acceptable material families and example materials for instrument manufacture, including stainless steels, titanium, titanium alloys, ceramics, hard metals, coatings, surface treatments and polymers.
The body of the document points to the evidence needed for design control, pre-clinical testing, clinical evaluation where required, sterilization validation, labeling and instructions for use. For a reader, that means the standard is mainly a framework for deciding whether an instrument can be specified, tested, manufactured and documented for dental implant work.
Relations
- Consolidated By
ISO 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment - Effective Date
- 12-Feb-2026
- Effective Date
- 04-Oct-2023
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Frequently Asked Questions
FprEN ISO 13504 is a draft published by the European Committee for Standardization (CEN). Its full title is "Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/FDIS 13504:2026)". 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.
FprEN ISO 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.
FprEN ISO 13504 has the following relationships with other standards: It is inter standard links to ISO 13504, EN ISO 13504:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
FprEN ISO 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)
SLOVENSKI STANDARD
oSIST prEN ISO 13504:2024
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
oSIST prEN ISO 13504:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 13504:2024
oSIST prEN ISO 13504:2024
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)
oSIST prEN ISO 13504:2024
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
oSIST prEN ISO 13504:2024
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
oSIST prEN ISO 13504:2024
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
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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
oSIST prEN ISO 13504:2024
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
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
oSIST prEN ISO 13504:2024
oSIST prEN ISO 13504:2024
DRAFT International Standard ISO/DIS 13504:2024(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 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.
It is not applicable to 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 of 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 1043-1, Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics
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, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135 (series), Sterilization of health care products — Ethylene oxide
ISO 11137 (series), Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 14155, Clinical investigation
...