kSIST FprEN ISO 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
• Public Enquiry End Date: 09-Sep-2024
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 30-Jul-2026
• Due Date: 17-Sep-2026
• Ref Project: FprEN ISO 13504 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/FDIS 13504:2026)

• Revises: SIST 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

kSIST FprEN ISO 13504:2026 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment - is an international standard developed by SIST. It specifies comprehensive requirements for the design, manufacture, performance, and labelling of instruments and accessories used for the placement of dental implants. The standard ensures that both single-use and reusable dental instruments, whether manually operated or part of powered systems, meet safety and quality benchmarks. However, it does not cover dental implants themselves, their connecting parts, or power-driven systems.

This standard plays a key role in harmonizing the approval procedures for dental implant instruments across different countries, helping manufacturers and dental professionals by reducing duplicated efforts in testing and certification, and promoting public health and patient safety.

Key Topics

• Classification and Intended Use
  Instruments are classified according to use (manual or motor-driven), tissue contact (hard, soft, or none), and reprocessing requirements (single-use or reusable).

• Performance Requirements
  Clear specifications for intended performance, functional characteristics, and validated test results are mandatory to ensure instruments are fit for purpose.

• Material Selection and Biocompatibility
  Materials must be selected to meet requirements for biological safety, durability, and compatibility with sterilization processes. Stainless steels, titanium, titanium alloys, ceramics, specific hard metals, approved coatings, surface treatments, and selected polymers are covered.

• Manufacturing and Technical Documentation
  Manufacturers must document compliance through technical files, including classification, materials, performance data, and information required for safe use and maintenance.

• Sterilization and Reprocessing
  Guidance is provided for instruments supplied sterile or non-sterile, including validation and control of sterilization processes (ethylene oxide, radiation, moist heat), and detailed instructions for user reprocessing where applicable.

• Labeling and Instructions for Use
  The standard outlines mandatory labelling on instruments and packaging, including manufacturer details, batch or lot numbers, intended use, sterilization status, and reprocessing guidance.

Applications

kSIST FprEN ISO 13504:2026 is vital for:

• Dental Instrument Manufacturers:
  Ensures products conform to internationally recognized safety and performance requirements, supporting market access and compliance with local regulations.

• Regulatory Authorities:
  Provides a benchmark for evaluating dental implant instruments and accessories, streamlining conformity assessment, and enhancing patient safety.

• Dental Professionals:
  Assures clinicians and dental staff that the instruments used in dental implant placement procedures meet rigorous standards for material quality, performance, and sterility.

• Healthcare Procurement:
  Supports procurement decisions by identifying products that comply with harmonized quality and safety standards for dental surgery.

Related Standards

This standard aligns with and references several important documents, including:

• ISO 1942: Dentistry - Vocabulary
• ISO 10993-1: Biological evaluation of medical devices
• ISO 14971: Risk management for medical devices
• ISO 13485: Medical devices - Quality management systems
• ISO 17664, ISO 17665, ISO 11135, ISO 11137: Sterilization requirements
• ISO 5832 series: Implants for surgery - Metallic materials
• ISO 15223-1: Symbols for information supplied by the manufacturer
• ISO 21850-1: Materials for dental instruments - Stainless steel

By complying with kSIST FprEN ISO 13504:2026, manufacturers, suppliers, and clinicians contribute to improved safety, reliability, and effectiveness in dental implantology, reflecting best practices in material selection, performance verification, and patient care.

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: [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
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
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
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
...