FprEN ISO 13504

• 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: 20-Dec-2026
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Current Stage: 5020 - Submission to Vote - Formal Approval
• Start Date: 23-Jul-2026
• Completion Date: 23-Jul-2026
• Ref Project: oSIST prEN ISO 13504:2024 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2024)

• Consolidated By: ISO/FDIS 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
• Effective Date: 12-Feb-2026
• Revises: EN ISO 13504:2012 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
• Effective Date: 04-Oct-2023

Overview

FprEN ISO 13504 is a harmonized international standard developed by CEN and ISO that sets out the general requirements for instruments and related accessories used in dental implant placement and treatment. Addressing both safety and performance, the standard is applicable to single-use and reusable dental instruments-whether manually or power-driven-that are used directly in dental implant procedures. The standard does not cover the actual implants, items connected to the implant, power systems, or devices only making indirect contact with patients.

This standard aims to ensure a consistent level of quality, safety, and efficacy for dental implant instruments across global markets, reducing the need for repetitive national approvals and fostering best practices within dental device manufacturing.

Keywords: dental instruments, dental implant placement, implant accessories, sterilization, dental device safety, reusable dental instruments, single-use dental instruments, ISO 13504, CEN dental standards

Key Topics

• Scope and Applicability

  • Covers instruments and accessories used directly in dental implant placement and related craniofacial procedures
  • Applies to manually operated and power-driven instruments, for both single-use and reusable products

• Classification

  • By usage: manual vs. powered instruments
  • By tissue contact: hard tissue, soft tissue, or no tissue contact
  • By reprocessing: single-use or multiple-use instruments

• Safety and Performance Requirements

  • Intended performance must be documented, including functional characteristics and conditions of use
  • Performance attributes to consider: mechanical properties, usability, cleaning, material wear, contamination levels, and interaction with body tissues
  • Material selection tailored for safety and compatibility (e.g., stainless steel, titanium, ceramics, proven polymers)

• Manufacturing and Quality

  • Specifications aligned with intended performance and relevant international material and manufacturing standards
  • Technical documentation must cover classification, design, material choice, evaluation procedures, and sterilization

• Sterilization and Reprocessing

  • Procedures referenced include methods validated according to ISO standards such as ethylene oxide, radiation, and moist heat
  • Clear instructions for sterilization and, where appropriate, reprocessing must be provided by manufacturers

• Labelling and Information for Users

  • Instruments and packaging must be clearly marked with the manufacturer’s information, lot and reference numbers, size or depth indicators, and single-use indications as applicable
  • Instructions for use and any necessary warnings regarding re-use are mandatory

Applications

• Dental Clinics and Practitioners

  • Assurance of reliable, safe, and effective instruments for implant procedures, aiding patient safety and optimal clinical outcomes
  • Ease of instrument selection due to standardized classification and labelling

• Manufacturers of Dental Instruments

  • Clear guidance to streamline product development, quality assurance, and compliance with international market requirements
  • Harmonized requirements facilitate easier entry into global markets and recognition by regulatory authorities

• Regulatory and Certification Bodies

  • Benchmarks for conformity assessment and approval of dental implant instruments
  • Reference for auditing and certifying manufacturing processes, sterilization, and documentation

Related Standards

• ISO 7405: Biocompatibility evaluation of dental devices
• ISO 10993-1: Biological risk management of medical devices
• ISO 13485: Quality management systems for medical devices
• ISO 11135/11137/17665: Sterilization processes for healthcare products
• ISO 17664: Information to be provided by the manufacturer for processing reusable medical devices
• ISO 21850-1: Stainless steel materials for dental instruments
• ISO 14971: Risk management for medical devices

These referenced standards cover essential aspects such as biocompatibility, sterilization, material safety, and quality management, ensuring that FprEN ISO 13504-compliant instruments meet both technical and regulatory requirements across the dental sector.

Adhering to FprEN ISO 13504 helps manufacturers, dental professionals, and regulators ensure the highest levels of safety and performance in dental implantology.

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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
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
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
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
...