prEN ISO 10650

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.
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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
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10650:2025(en)
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
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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10650:2025(en)
ii
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
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
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
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

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
...