EN ISO 10650:2026

Dentistry - Powered polymerization activators (ISO 10650:2026)

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document is applicable to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators can be powered by an internal power supply (rechargeable battery powered) or can be powered by external (mains) power or can be powered by a dental unit. Lasers or plasma arc devices are not covered by this document.
This document does not apply to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

Zahnheilkunde- Polymerisationslampen (ISO 10650:2026)

Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2026)

Le présent document spécifie les exigences et les méthodes d’essai relatives aux activateurs électriques de polymérisation, dans le domaine de longueur d’onde de 380 nm à 515 nm, destinés à être utilisés à proximité du fauteuil dentaire pour polymériser les matériaux dentaires à base de polymères.
Le présent document est applicable aux lampes halogènes au tungstène à quartz et aux lampes à diodes électroluminescentes (LED). Les activateurs électriques de polymérisation peuvent être alimentés par une alimentation interne (alimentés par une batterie rechargeable) ou peuvent être alimentés par une puissance (mains) externe ou peuvent être alimentés par une unité dentaire. Les dispositifs à lasers ou à arc plasma ne sont pas couverts par le présent document.
Le présent document ne s'applique pas aux activateurs électriques de polymérisation utilisés en laboratoire pour la fabrication des restaurations indirectes, facettes, prothèses ou autres appareils buccaux.

Zobozdravstvo - Polimerizacijski aktivatorji (ISO/FDIS 10650:2026)

General Information

• Status: Not Published
• Publication Date: 07-Jul-2026
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 10-May-2026
• Completion Date: 10-May-2026
• Ref Project: kSIST FprEN ISO 10650:2026 - Dentistry - Powered polymerization activators (ISO/FDIS 10650:2026)

Relations

• Consolidated By: ISO 10650 - Dentistry — Powered polymerization activators
• Effective Date: 12-Feb-2026
• Revises: EN ISO 10650:2018 - Dentistry - Powered polymerization activators (ISO 10650:2018)
• Effective Date: 30-Oct-2024

Overview

EN ISO 10650:2026 – Dentistry: Powered Polymerization Activators is an international standard developed by CEN, harmonizing requirements for devices that emit light in the 380 nm to 515 nm wavelength region for the polymerization of dental polymer-based materials. These devices, commonly known as dental curing lights, are essential for chairside dental procedures such as restorative work and bonding. The standard applies specifically to quartz-tungsten-halogen (QTH) lamps and light-emitting diode (LED) lamps, regardless of whether they are powered by mains electricity, rechargeable batteries, or dental units. It excludes laboratory polymerization equipment, lasers, and plasma arc devices.

This standard defines performance requirements, safety criteria, conformity assessment, and test methods, ensuring safe and effective polymerization of dental materials while minimizing risks to patients and dental professionals. The requirements also address cleaning, disinfection, usability, and essential information to be supplied by manufacturers.

Key Topics

• Wavelength Coverage: Focuses on curing equipment emitting in the 380 nm to 515 nm range, which is critical for most light-cured dental materials.
• Device Types: Applicable to QTH lamps and LED units, both mains-powered and rechargeable.
• Exclusions: Does not cover devices such as lasers, plasma arc lights, nor those used for laboratory fabrication of indirect restorations.
• Safety Requirements: Aligns with IEC 60601 and IEC 80601-2-60 standards for electrical and mechanical safety.
• Radiant Exitance: Specifies limits for energy output to ensure effective polymerization without risk of heat or light-induced injury.
• Blue Light Hazard: Highlights the retinal risk from blue light exposure and recommends protective filtering devices for dentists, dental assistants, and patients.
• Testing and Conformity: Details standardized test methods for radiant exitance, durability, and usability, including both spectrometer-based and filter-based measurements.
• Instructions for Use: Manufacturers must provide clear guidelines on operation, safety, cleaning, and maintenance.

Applications

The practical value of EN ISO 10650:2026 lies in its direct application to dental clinical settings where fast and reliable polymerization of composite resins, adhesives, sealants, and similar materials is required.

Key applications include:

• Direct Restorative Procedures: Ensures reliable curing of fillings, liners, and adhesives at the chairside.
• Orthodontic Bonding: Used for light-curing orthodontic adhesives for brackets and appliances.
• Emergency Repairs: Quick, safe curing for in-situ repairs of dental appliances.
• In-Office Manufacture: Used in procedures requiring the immediate setting of certain materials, such as temporary crowns.
• Dental Staff and Patient Safety: Ensures reduced risk of retinal hazards and heat injury, provided the specification of protective filter devices is followed.

Adhering to this standard helps dental practices choose compliant equipment, train staff safely, and assure patients of the highest quality and safety in light-cured treatments.

Related Standards

Professionals implementing EN ISO 10650:2026 may also reference the following standards to ensure comprehensive compliance and optimal safety:

• IEC 60601 Series: General requirements for safety in medical electrical equipment.
• IEC 80601-2-60: Particular requirements for dental equipment safety.
• ISO 9687: Graphical symbols for dental equipment.
• ISO 15223-1: Symbols to be used with medical device information.
• IEC 62366-1: Usability engineering for medical devices.
• ISO 17664: Manufacturer guidance for cleaning, disinfection, and sterilization processes for healthcare products.

Following these related standards, in addition to EN ISO 10650:2026, supports comprehensive regulatory compliance and enhances overall safety and efficacy in dental practices utilizing powered polymerization activators.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 10650:2025
01-april-2025
Zobozdravstvo - Polimerizacijski aktivatorji (ISO/DIS 10650:2025)
Dentistry - Powered polymerization activators (ISO/DIS 10650:2025)
Zahnheilkunde- Polymerisationslampen (ISO/DIS 10650:2025)
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO/DIS
10650:2025)
Ta slovenski standard je istoveten z: prEN ISO 10650
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 10650:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 10650:2025
oSIST prEN ISO 10650:2025
DRAFT
International
Standard
ISO/DIS 10650
ISO/TC 106/SC 6
Dentistry — Powered
Secretariat: DIN
polymerization activators
Voting begins on:
Médecine bucco-dentaire — Activateurs électriques de
2025-02-17
polymérisation
Voting terminates on:
ICS: 11.060.20 2025-05-12
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 10650:2025(en)
oSIST prEN ISO 10650:2025
DRAFT
ISO/DIS 10650:2025(en)
International
Standard
ISO/DIS 10650
ISO/TC 106/SC 6
Dentistry — Powered
Secretariat: DIN
polymerization activators
Voting begins on:
Médecine bucco-dentaire — Activateurs électriques de
polymérisation
Voting terminates on:
ICS: 11.060.20
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 2025
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 10650:2025(en)
ii
oSIST prEN ISO 10650:2025
ISO/DIS 10650:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General .2
5.1.1 Design . .2
5.1.2 Connection .2
5.1.3 Operating controls .2
5.1.4 Cleaning, disinfection and sterilization .3
5.1.5 Excessive temperature.3
5.2 Radiant exitance .3
5.2.1 General .3
5.2.2 Radiant exitance in the 380 nm to 515 nm wavelength region .3
5.2.3 Radiant exitance in the wavelength region below 380 nm .3
5.2.4 Radiant exitance in the wavelength region above 515 nm .3
5.3 Electrical safety requirements .3
5.4 Physical and mechanical safety .4
5.5 Usability .4
5.6 Instructions for use manual .4
5.7 Technical Description .4
5.8 Marking .4
5.9 Packaging .4
6 Sampling . 4
7 Measurement and test methods . 4
7.1 General .4
7.1.1 General provisions for tests .4
7.1.2 Atmospheric conditions .5
7.2 Inspections .5
7.2.1 Visual inspection of powered polymerization activator .5
7.2.2 Manual inspection of powered polymerization activator .5
7.2.3 Visual inspection of manufacturer’s document .5
7.3 Measurement of the optical cross-sectional area of the light guide/light-emitting tip .5
7.3.1 Apparatus .5
7.3.2 Procedure .5
7.4 Measurement of radiant exitance .5
7.4.1 Method A using spectrometer .5
7.4.2 Method B using filters .8
8 Information (instructions for use) to be supplied by the manufacturer .12
9 Marking . .13
10 Packaging. 14
Bibliography .15

iii
oSIST prEN ISO 10650:2025
ISO/DIS 10650:2025(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 6, Dental
equipment.
This third edition cancels and replaces the second edition (ISO 10650:2018), which has been technically
revised.
The main changes are as follows:
— an addition in the Introduction on blue light hazard to the retina from exposure to emission from power
polymerization activators and the use of protective filtering devices;
— Figure 5 in the test procedure using filters (Method B, 7.4.2) is corrected;
— a change in 8.2 (h) from “recommendation on the effective use of protective filter glasses by dentist,
dental assistant, and patient to decrease exposure” to “recommendation on the effective use of protective
filtering devices intended for use with powered polymerization activators by dentist, dental assistant,
and patient to decrease exposure”;
— an addition to the Instruction for Use: “8.5 “Revision date or other version identifier of the instructions
for use”;
— editorial update.
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 10650:2025
ISO/DIS 10650:2025(en)
Introduction
This document specifies requirements and test methods in the wavelength region below 380 nm, the
380 nm to 515 nm wavelength region and the wavelength region above 515 nm for powered polymerization
activators. No minimum requirement value is given for the 380 nm to 515 nm wavelength region. For the
380 nm to 515 nm wavelength region, the maximum radiant exitance has been specified in order to mitigate
risks for patients.
There is a risk of tissue damage caused by heat development during photo-polymerization when sufficiently
high irradiances are applied for long enough time. There is a risk of inadequate polymerization of resin-
based materials when irradiated by powered polymerization activators with high radiant exitance for very
short irradiation time resulting in insufficient combinations of irradiance and irradiation time. There is also
a risk of inadequate polymerization of resin-based materials when irradiated with low irradiance and short
irradiation time. There is no complete reciprocity between irradiance and curing time, i.e. a time threshold
exists under which the polymerization will not proceed sufficiently. Therefore it is important to follow the
instructions for use of the composite manufacturers.
The spectral emission of powered polymerization activators typically overlaps substantially with the blue-
light hazard function for induction of retinal damage (peak interval between 435 nm and 440 nm). Both
patients and dental healthcare professionals may be exposed to visible light from powered polymerization
activators. Exposure may be either direct or indirect (i.e., reflected). Protective filtering devices intended
for use with powered polymerization activators can mitigate the retinal blue-light hazard exposure by
attenuating the light in the wavelength range of concern. This document recommends the effective use
of protective filter devices by dentist, dental assistant, and patient to decrease exposure. A standard for
protective filtering devices for use with powered polymerization activators is being developed.
This document refers to IEC 60601, the basic International Standard on safety of medical electrical
equipment, wherever relevant, by stating the respective clause numbers of IEC 60601.

v
oSIST prEN ISO 10650:2025
oSIST prEN ISO 10650:2025
DRAFT International Standard ISO/DIS 10650:2025(en)
Dentistry — Powered polymerization activators
1 Scope
This document specifies requirements and test methods for powered polymerization activators in the
380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based
materials.
This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered
polymerization activators could have internal power supply (rechargeable battery powered) or be connected
to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard.
This document does not cover powered polymerization activators used in laboratory fabrication of indirect
restorations, veneers, dentures or other oral dental appliances.
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 9687, Dentistry — Graphical symbols for dental equipment
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer
for the processing of medical devices
IEC 60601-1:2005+AMD1:2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance + Amendment 1:2012
IEC 60601-1-2, Medical electrical equipment — Part 1: General requirements for safety — 2. Collateral Standard:
Electromagnetic compatibility — Requirements and test
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, IEC 60601-1 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
powered polymerization activator
device producing a light beam primarily in the 380 nm to 515 nm region, intended for chairside use in
polymerizing polymer-based filling, restorative and luting materials

oSIST prEN ISO 10650:2025
ISO/DIS 10650:2025(en)
3.2
light-emitting diode (LED) lamps
semiconductor-based light emitting lamps
3.3
fully charged battery
battery which at the beginning of the testing is 100 % of the first full charge
3.4
radiant exitance
quotient of the radiant flux leaving an element of the surface containing the point, by the area of the element
3.5
irradiance
quotient of the radiant flux incident on an element of the surface containing the point, by the area of the element
3.6
radiant flux
power emitted, transmitted or received in the form of radiation
4 Classification
Powered polymerization activators are classified according to their lamps and power supply as follows:
— Class 1: Quartz-tungsten-halogen lamps:
— Type 1: Polymerization activators powered with mains supply;
— Type 2: Polymerization activators powered with rechargeable battery supply;
— Class 2: Light-emitting dio
...