SIST EN ISO 10650:2026

SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 10650:2018
Zobozdravstvo - Polimerizacijski aktivatorji (ISO 10650:2026)
Dentistry - Powered polymerization activators (ISO 10650:2026)
Zahnheilkunde- Polymerisationslampen (ISO 10650:2026)
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2026)
Ta slovenski standard je istoveten z: EN ISO 10650:2026
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10650
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 10650:2018
English Version
Dentistry - Powered polymerization activators (ISO
10650:2026)
Médecine bucco-dentaire - Activateurs électriques de Zahnheilkunde- Polymerisationslampen (ISO
polymérisation (ISO 10650:2026) 10650:2026)
This European Standard was approved by CEN on 10 May 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10650:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10650:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2027, and conflicting national standards shall
be withdrawn at the latest by January 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10650:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10650:2026 has been approved by CEN as EN ISO 10650:2026 without any modification.

International
Standard
ISO 10650
Third edition
Dentistry — Powered
2026-06
polymerization activators
Médecine bucco-dentaire — Activateurs électriques de
polymérisation
Reference number
ISO 10650:2026(en) © ISO 2026
ISO 10650:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10650:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 General .3
5.1.1 Design . .3
5.1.2 Connection .3
5.1.3 Operating controls .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 Instructions for use .4
5.4 Marking .4
5.5 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 .4
7.2 Inspections .4
7.2.1 Visual inspection of powered polymerization activator .4
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.13
Bibliography . 14

iii
ISO 10650:2026(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 document 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, 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 third edition cancels and replaces the second edition (ISO 10650:2018), which has been technically
revised.
The main changes are as follows:
— content has been added to the Introduction on blue light hazard to the retina from exposure to emission
from power polymerization activators and the use of protective filtering devices;
— an additional classification of powered polymerization activators along with corresponding requirements
and test methods have been added (i.e. Type 3, polymerization activators powered by connection to a
dental unit);
— Figure 3 and Figure 5 in the test procedure using filters (Method B, 7.4.2) have been corrected;
— requirements duplicated in the document from other medical device international standards (i.e.
[1] [2] [3] [4]
references to IEC 60601-1 , IEC 60601-1-2 , IEC 62366-1 and IEC 80601-2-60 ) have been deleted;
— a requirement for the manufacturer to provide information about protective filtering devices has been
added in 8.1, list item i);
— content was added to Clause 8: “Revision date or other version identifier of the instructions for use”;
— editorial updates.
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 10650:2026(en)
Introduction
Powered polymerization activators are used in dentistry to polymerize light-activated dental materials
by emitting optical radiation within specified wavelength ranges. They are commonly used in restorative,
orthodontic and preventive dental procedures to cure polymer-based materials, adhesives, sealants and
related materials. Powered polymerization activators are designed to deliver controlled irradiance, spectral
output and exposure duration to achieve adequate polymerization while minimizing thermal and biological
risks. The performance and safety of dental curing lights are critical to the clinical outcome, durability of
dental restorations and protection of patients and oral healthcare providers, necessitating standardized
requirements and test methods.
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 oral healthcare providers can be exposed to visible light from powered polymerization
activators. Exposure can 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.
[1]
IEC 60601-1 specifies requirements pertaining to the basic safety and essential performance of medical
[4]
electrical equipment and medical electrical systems. IEC 80601-2-60 specifies requirements pertaining
to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces
[1] [4]
and dental operating lights. Requirements of IEC 60601-1 and IEC 80601-2-60 applicable to powered
polymerization activators are not duplicated in this document.

v
International Standard ISO 10650:2026(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 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.
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 9687, Dentistry — Graphical symbols for dental equipment
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied — Part 1: General requirements
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
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
3.2
light-emitting diode lamp
LED lamp
semiconductor-based light emitting lamp

ISO 10650:2026(en)
3.3
fully charged battery
battery which at the beginning of the testing is 100 % of the first full charge
3.4
radiant exitance
M ; M
e
density of exiting radiant flux (3.6) with respect to area at a point on a real or imaginary surface
(1)
where Φ is radiant flux and A is the area from which the radiant flux leaves
e
Note 1 to entry: The radiant exitance is expressed in watt per square metre (W/m ).
[5]
[SOURCE: CIE e-ILV, 17-21-080 , modified — The original Notes 1, 2, 4 and 5 to entry have been deleted.]
3.5
irradiance
E , E
e
density of incident radiant flux (3.6) with respect to area at a point on a real or imaginary surface
(2)
where Φ is radiant flux and A is the area on which the radiant flux is incident
e
Note 1 to entry: The irradiance is expressed in watt per square metre (W/m ).
[6]
[SOURCE: CIE e-ILV, 17-21-053 , modified — The original Notes 1, 3 and 4 to entry have been deleted.]
3.6
radiant flux
power emitted, transmitted or received in the form of radiation
4 Classification
Powered polymerization activators are classified accord
...