oSIST prEN ISO 20126:2026

Dentistry - Manual toothbrushes - General requirements and test methods (ISO/DIS 20126:2026)

This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.
This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer.
This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.

Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren (ISO/DIS 20126:2026)

Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et méthodes d'essai (ISO/DIS 20126:2026)

Le présent document spécifie les exigences et les méthodes d'essai relatives aux caractéristiques physiques des brosses à dents manuelles afin de promouvoir la sécurité de ces produits dans les conditions d’utilisation prévues.
Le présent document ne spécifie pas les exigences et les méthodes d’essai relatives aux caractéristiques physiques des brosses à dents dont tous les éléments nettoyants de la tête sont en élastomère.
Le présent document ne s’applique pas aux brosses à dents manuelles monotouffe et aux dispositifs électriques interdentaires d’hygiène bucco-dentaire à usage unique. La sécurité d’emploi de ces types de produits d’hygiène bucco-dentaire est évaluée en appliquant des méthodes d’essai et des essais cliniques appropriés.
De plus, en ce qui concerne les exigences d’arrondissage des extrémités de filaments, le présent document ne s’applique pas aux types particuliers de filaments qui sont très fins (moins de 0,1 mm de diamètre extérieur) ou qui n’ont pas d’arêtes vives (par exemple effilés, amincis, à pointes divisées ou à calotte) ou aux filaments non synthétiques dans lesquels l’application du processus d’arrondissage des extrémités est inappropriée ou impossible. La sécurité d’emploi de ces types de brosses à dents manuelles est évaluée en appliquant des méthodes d’essai et des essais cliniques appropriés.

Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode (ISO/DIS 20126:2026)

Ta dokument določa zahteve in preskusne metode za fizikalne lastnosti ročnih zobnih ščetk, da bi zagotovili varnost teh izdelkov pri njihovi predvideni uporabi.
Ta dokument ne določa nobenih zahtev in preskusnih metod za fizikalne lastnosti zobnih ščetk, pri katerih so vsi čistilni elementi v glavi iz elastomera.
Ta dokument se ne uporablja za ročne enosnopne zobne ščetke, enkratno uporabo, medzobne in električne naprave za ustno higieno. Te vrste izdelkov za ustno higieno se ocenjujejo glede njihove varnosti pri uporabi z ustreznimi preskusnimi metodami ali kliničnimi preizkusi.
Poleg tega se za zahteve glede zaokroževanja konic vlaken ta dokument ne uporablja za določene vrste vlaken, ki so zelo tanka (zunaj premera manj kot 0,1 mm) ali nimajo ostrih robov (npr. koničasta, pernata, z razcepljenimi konicami ali sferična kapica) ali nesintetična vlakna, kjer je uporaba postopka zaokroževanja konic neprimerna ali nemogoča. Te vrste ročnih zobnih ščetk se ocenjujejo glede njihove varnosti pri uporabi z ustreznimi preskusnimi metodami ali kliničnimi preizkusi.

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Jun-2026
• ICS: 11.060.01 - Dentistry in general
• ICS: 97.170 - Body care equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 17-Apr-2026
• Due Date: 04-Sep-2026
• Ref Project: prEN ISO 20126 - Dentistry - Manual toothbrushes - General requirements and test methods (ISO/DIS 20126:2026)

Relations

• Revises: SIST EN ISO 20126:2022 - Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2022)
• Effective Date: 30-Oct-2024

Overview

oSIST prEN ISO 20126:2026:2026 (ISO/DIS 20126:2026) - Dentistry – Manual Toothbrushes – General Requirements and Test Methods is an international standard developed by CEN covering the safety and quality criteria for manual toothbrushes. The aim of this standard is to ensure that manual toothbrushes meet specific physical property requirements and are tested through defined methods. This promotes safety, performance, and user confidence in oral hygiene products globally.

The document applies specifically to manual toothbrushes with standard filament types used for oral care, excluding those with exclusively elastomer cleaning elements, single tuft brushes, single-use, interdental, and powered devices. Certain filament types, such as very thin or uniquely shaped filaments, are also outside of the scope for some requirements.

Key Topics

• Physical Property Requirements: The standard specifies pass-fail criteria for several physical properties of manual toothbrushes, including tuft retention, handle impact strength, and fatigue resistance, ensuring product durability and user safety.
• Filament End-Rounding: To minimize oral tissue injury, the standard requires a minimum percentage of filaments with rounded, smooth tips, except for specified filament types where rounding is not feasible.
• Elastomer Element Retention: For brushes including elastomer elements, there are minimum force or extension requirements to assess the secure attachment of these cleaning elements.
• Testing Methods: oSIST prEN ISO 20126:2026 provides detailed standardized test procedures for assessing toothbrush features, including physical inspections, mechanical retention tests, impact tests, and fatigue resistance, both before and after chemical exposure.
• Marking, Labelling, and Packaging: The standard addresses manufacturer traceability through codes, adequate information on packaging, and requirements for contaminant-free packaging.

Applications

oSIST prEN ISO 20126:2026:2026 is essential for:

• Manufacturers: Ensures consistency, safety, and reliability in the production of manual toothbrushes, helping manufacturers meet regulatory and market expectations.
• Quality Assurance: Provides a robust framework for developing and executing quality control processes, including incoming product verification, batch release, and supplier audits.
• Product Development: Guides the design of manual toothbrushes to meet international safety and performance benchmarks, supporting innovation while prioritizing consumer safety.
• Regulatory Compliance: Facilitates international trade and market access by harmonizing product requirements, allowing manufacturers to demonstrate conformity with established safety and quality criteria.
• Testing Laboratories: Standardizes mechanical and visual test methods, enabling accurate assessment and reporting of product compliance for regulatory submissions or market surveillance.

Related Standards

For comprehensive compliance and broader safety considerations in dental care product manufacturing, related international standards include:

• ISO 1942: Dentistry – Vocabulary
• ISO 22254: Dentistry – Manual toothbrushes – Resistance of tufted portion to deflection
• ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
• ISO 10993-1: Biological evaluation of medical devices – Part 1: General principles for the evaluation of biological safety within a risk management process
• ISO 3696: Water for analytical laboratory use – Specification and test methods
• ISO 13802 / ASTM D256-10: Standards for impact-testing apparatus and methods

Practical Value

By adhering to oSIST prEN ISO 20126:2026, stakeholders in the oral care industry can:

• Reduce Product Liability: By ensuring products are tested to recognized safety standards.
• Enhance Consumer Trust: Deliver toothbrushes proven to meet international safety and performance benchmarks.
• Streamline International Trade: Benefit from harmonized standards that facilitate market entry and regulatory approval in various jurisdictions.
• Support Ongoing Innovation: Provide a clear technical framework that encourages the development of safer and more effective oral care products.

Implementing this standard is fundamental for maintaining high safety and quality in manual toothbrushes, safeguarding user health, and ensuring market competitiveness.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Zobozdravstvo - Ročne zobne ščetke - Splošne zahteve in preskusne metode
(ISO/DIS 20126:2026)
Dentistry - Manual toothbrushes - General requirements and test methods (ISO/DIS
20126:2026)
Zahnheilkunde - Handzahnbürsten - Allgemeine Anforderungen und Prüfverfahren
(ISO/DIS 20126:2026)
Médecine bucco-dentaire - Brosses à dents manuelles - Exigences générales et
méthodes d'essai (ISO/DIS 20126:2026)
Ta slovenski standard je istoveten z: prEN ISO 20126
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
97.170 Oprema za nego telesa Body care equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 20126
ISO/TC 106/SC 7
Dentistry — Manual toothbrushes
Secretariat: JISC
— General requirements and test
Voting begins on:
methods
2026-04-07
Médecine bucco-dentaire — Brosses à dents manuelles —
Voting terminates on:
Exigences générales et méthodes d'essai
2026-06-30
ICS: 97.170
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 20126:2026(en)
DRAFT
ISO/DIS 20126:2026(en)
International
Standard
ISO/DIS 20126
ISO/TC 106/SC 7
Dentistry — Manual toothbrushes
Secretariat: JISC
— General requirements and test
Voting begins on:
methods
Médecine bucco-dentaire — Brosses à dents manuelles —
Voting terminates on:
Exigences générales et méthodes d'essai
ICS: 97.170
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 2026
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 20126:2026(en)
ii
ISO/DIS 20126:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Pass-fail criteria .3
4.1.1 Pass-fail criteria except for filament end-rounding .3
4.1.2 Pass-fail criteria for filament end-rounding .3
4.2 Physical inspection .3
4.3 Tuft retention .3
4.4 Elastomer element retention .3
4.5 Handle impact strength .4
4.6 Fatigue resistance .4
4.7 Fatigue resistance after chemical challenge .4
4.8 Filament end-rounding .4
5 Test method . 4
5.1 Sampling .4
5.2 General test conditions .4
5.3 Physical inspection .4
5.4 Tuft retention test .4
5.4.1 Apparatus .4
5.4.2 Procedure .5
5.5 Elastomer element retention test .5
5.5.1 Apparatus .5
5.5.2 Procedure .6
5.6 Handle impact test .6
5.6.1 Apparatus .6
5.6.2 Procedure .7
5.7 Fatigue resistance test .8
5.7.1 Apparatus .8
5.7.2 Procedure .9
5.8 Fatigue resistance test after chemical challenge .9
5.8.1 Apparatus and chemicals.9
5.8.2 Procedure .9
5.9 Visual inspection for filament end-rounding .9
5.9.1 General .9
5.9.2 Apparatus .10
5.9.3 Procedure .10
6 Test report .11
7 Marking and labelling .11
8 Packaging.12
Bibliography .13

iii
ISO/DIS 20126:2026(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 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 7, Oral care
products, 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 fourth edition cancels and replaces the third edition (ISO 20126: 2022), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— a requirement (4.4) and a test method (5.5) for elastomer element retention have been added;
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 20126:2026(en)
Introduction
This document is intended to determine the physical properties of manual toothbrushes which are used for
the removal of dental plaque and oral debris in order to facilitate oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included
in this document. It is recommended that, in assessing possible biological hazards, reference be made to
ISO 7405 and ISO 10993-1.
v
DRAFT International Standard ISO/DIS 20126:2026(en)
Dentistry — Manual toothbrushes — General requirements
and test methods
1 Scope
This document specifies requirements and test methods for the physical properties of manual toothbrushes
in order to promote the safety of these products for their intended use.
This document does not specify any requirements and test methods for the physical properties of
toothbrushes for which all the cleaning elements in the head are elastomer.
This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral
hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate
test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particular
filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered,
feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process
is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by
appropriate test methods or clinical trials.
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 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 22254, Dentistry — Manual toothbrushes — Resistance of tufted portion to deflection
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
manual toothbrush
hand-powered device, the working end of which carries filaments (3.3) primarily for cleaning surfaces
within the oral cavity
3.2
brush head
working end of a manual toothbrush (3.1) to which the filaments (3.3) and/or elastomer elements (3.12) are
attached
...