ISO/FDIS 10650

Formatted: French (Switzerland)
ISO/DISFDIS 10650
Formatted: French (Switzerland)
ISO/TC 106/SC 6
Secretariat: DIN
Date: 2025-11-142026-01-28
Dentistry — Powered polymerization activators
Médecine bucco-dentaire — Activateurs électriques de polymérisation
DISFDIS stage
Warning for WD’s and CD’s
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change
without notice and may not be referred to as an International Standard.
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.
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ISO/DISFDIS 10650:20252026(en)
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Formatted: French (Switzerland)
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Formatted: German (Germany)
Formatted: German (Germany)
Published in Switzerland
Formatted: German (Germany)
Field Code Changed
iii
ISO/DISFDIS 10650:20252026(en)
Contents
Foreword . iv
Introduction . iv
Scope . iv
Normative references . iv
Terms and definitions . iv
Classification . iv
Requirements . iv
General . iv
Radiant exitance . iv
Instructions for use . iv
Marking . iv
Packaging . iv
Sampling . iv
Measurement and test methods . iv
General . iv
Inspections . iv
Measurement of the optical cross-sectional area of the light guide/light-emitting tip . iv
Measurement of radiant exitance . iv
Information (instructions for use) to be supplied by the manufacturer . iv
Marking . iv
Packaging . iv
Bibliography . iv
Foreword . vi
Introduction . viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification. 2
5 Requirements . 3
5.1 General. 3
5.2 Radiant exitance . 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
7.2 Inspections . 5
7.3 Measurement of the optical cross-sectional area of the light guide/light-emitting tip . 5
7.4 Measurement of radiant exitance . 5
8 Information (instructions for use) to be supplied by the manufacturer . 15
iv
ISO/DISFDIS 10650:20252026(en)
9 Marking . 16
10 Packaging . 17
Bibliography . 18

v
ISO/DISFDIS 10650:20252026(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. IEC
[1] [2]
60601-1, IEC 60601-1-2, IEC 62366-1 and IEC 80601-2-60)references to IEC 60601-1 , IEC 60601-1-2 ,
[3] [4]
IEC 62366-1 and EN IEC 80601-2-60 ) have been deleted;
— a requirement for the manufacturer to provide information about protective filtering devices has been
added in 8.2 h);
— content was added to Clause 8: “Revision date or other version identifier of the instructions for use”;
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ISO/DISFDIS 10650:20252026(en)
— 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.
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ISO/DISFDIS 10650:20252026(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 polymer-
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 polymer-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 polymer-based material manufacturers.
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 resin-based composites, 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 60601-1IEC 60601-1 specifies requirements pertaining to the basic safety and essential performance of
[4]
medical electrical equipment and medical electrical systems. IEC 80601-2-60EN IEC 80601-2-60 specifies
requirements pertaining to the basic safety and essential performance of dental units, dental patient chairs,
dental handpieces and dental operating lights. Requirements of IEC 60601-1 and IEC 80601-2-60IEC 60601-
[1] [4]
1 and EN IEC 80601-2-60 applicable to powered polymerization activators are not duplicated in this
document.
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ISO/DISFDIS 10650:20252026(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 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 60601-1:2005+AMD1:2012+AMD:2020, Medical electrical equipment —- Part 1: General requirements for
Formatted: Font: Italic
basic safety and essential performance
Formatted: Font: Italic
ISO 1942, Dentistry — Vocabulary
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 17664-1, 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
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
Formatted: English (United States)
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/DISFDIS 10650:20252026(en)
3.2
Formatted: English (United States)
light-emitting diode (LED) lamps
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
Formatted: English (United States)
radiant exitance
M ; M
e
density of exiting radiant flux with respect to area at a point on a real or imaginary surface
𝑑𝑑𝛷𝛷
e
𝑀𝑀 =
e
𝑑𝑑𝑑𝑑
where Φ is radiant flux and A is the area from which the radiant flux leaves
e Formatted: Font: Italic
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] , modified — The original Notes 1, 2, 4 and 5 to entry have been
deleted.]
3.5
Formatted: English (United States)
irradiance
E , E
e
density of incident radiant flux with respect to area at a point on a real or imaginary surface
𝑑𝑑𝛷𝛷
e
𝐸𝐸 =
e
𝑑𝑑𝑑𝑑
where Φ is radiant flux and A is the area on which the radiant flux is incident
e Formatted: Font: Italic
Note 1 to entry: The irradiance is expressed in watt per square metre (W/m ).
[6]
[SOURCE: CIE e-ILV, 17-21-053, modified] , modified — The original Notes 1, 3 and 4 to entry have been
deleted.]
3.6
Formatted: English (United States)
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:
Formatted: German (Germany)
— Type 1: Polymerization activators powered by mains supply;
— Type 2: Polymerization activators powered by rechargeable battery supply;
— Type 3: Polymerization activators powered by connection to a dental unit.
— Class 2: Light-emitting diode (LED) lamps:
ISO/DISFDIS 10650:20252026(en)
— Type 1: Polymerization activators powered by mains supply;
— Type 2: Polymerization activators powered by rechargeable battery/capacitor;
— Type 3: Polymerization activators powered by connection to a dental unit.
5 Requirements
5.1 General
5.1.1 Design
The construction of powered polymerization activators shall provide for safe and reliable operation. If field-
repairable, the powered polymerization activator shall be capable of being easily disassembled and
reassembled for maintenance and repair, using readily available tools or those supplied by the manufacturer.
Test conformity in accordance with 7.2.1.
5.1.2 Connection
Type 1 and Type 3 powered polymerization activators shall be capable of being disconnected and reconnected
from the supply for cleaning and disinfection.
Conformity shall be checked in accordance with 7.2.2.
5.1.3 Operating controls
Operating controls shall be designed and located to minimize accidental activation.
Conformity shall be checked by 7.2.1 and 7.2.2.
5.2 Radiant exitance
5.2.1 General
The requirements for radiant exitance shall be met when tested at each continuous irradiation mode or pulse
mode time period as specified by the manufacturer. If no time period is specified, the time period shall be 20
s.
For Type 1 polymerization activators, the requirement applies at the operating voltage (rated voltage).
For Type 2 polymerization activators, the requirement applies only to a fully charged powered polymerization
activator.
For Type 3 Polymerization activators, the requirement applies at the operating voltage (rated voltage)
delivered by the dental unit.
5.2.2 Radiant exitance in the 380 nm to 515 nm wavelength region
Formatted: English (United States)
The radiant exitance in the 380 nm to 515 nm wavelength region shall not be more than 40 000 W/m (4 000
mW/cm ) when tested in accordance with 7.4, either Method A (7.4.1) or Method B (7.4.2).
The manufacturer shall provide information on the radiant exitance in this region as determined by the test
methods in 7.4. The radiant exitance shall vary by no more than ±20 % of the manufacturer’s stated radiant
exitance (see Clause 8.1, list item o)). Test for conformity in accordance with 7.2.3.
ISO/DISFDIS 10650:20252026(en)
5.2.3 Radiant exitance in the wavelength region below 380 nm
Formatted: English (United States)
The radiant exitance in the wavelength region below 380 nm shall be no more than 2 000 W/m (200
mW/cm ) when tested in accordance with 7.4, either Method A (7.4.1) or Method B (7.4.2).
5.2.4 Radiant exitance in the wavelength region above 515 nm
Formatted: English (United States)
The radiant exitance in the wavelength region above 515 nm shall be no more than 1 000
...