Dentistry - Protective filtering devices intended for use with powered polymerization activators (ISO/DIS 7260:2026)

This document specifies requirements, test methods, and labeling for protective filtering devices intended for protection against retinal blue light exposure from powered polymerization activators in the scope of ISO 10650:2018, i.e., powered polymerization activators using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization. This document does not apply to protective filtering devices for lasers or plasma arc devices.

Zahnheilkunde - Schutzfilter zur Verwendung mit elektrischen Polymerisationsgeräten (ISO/DIS 7260:2026)

Médecine bucco-dentaire - Dispositifs de protection filtrants destinés à être utilisés avec des activateurs électriques de polymérisation (ISO/DIS 7260:2026)

Zobozdravstvo - Zaščitne filtrirne naprave namenjene za uporabo z električnimi polimerizacijskimi aktivatorji (ISO/DIS 7260:2026)

Ta dokument določa zahteve, preskusne metode in označevanje zaščitnih filtrirnih naprav, namenjenih za zaščito pred izpostavljenostjo mrežnice modri svetlobi iz aktivatorjev za polimerizacijo v okviru ISO 10650:2018, tj. aktivatorjev za polimerizacijo, ki uporabljajo kremen-volfram halogenske žarnice ali svetleče diode (LED) za aktivacijo polimerizacije. Ta dokument ne velja za zaščitne filtrirne naprave za laserje ali naprave s plazemskim lokom.

General Information

Status
Not Published
Public Enquiry End Date
30-May-2026
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
26-Mar-2026
Due Date
13-Aug-2026

Overview

oSIST prEN ISO 7260:2026:2026 – Dentistry - Protective filtering devices intended for use with powered polymerization activators – is a comprehensive standard developed by CEN and ISO for the dental sector. This international standard specifies the requirements, test methods, and labeling for protective filtering devices designed to reduce retinal blue light exposure when using powered polymerization activators such as quartz-tungsten halogen lamps and LEDs, as described in ISO 10650:2018. It provides guidance on performance, construction, and instructions for both eyewear and filters used in dental procedures involving light-curing technologies. The standard does not address protective devices for lasers or plasma arc sources.

Key Topics

  • Blue-Light Hazard Mitigation: Defines limits for blue-light weighted transmittance (380 nm to 550 nm) to help prevent photochemically induced retinal injuries for both patients and dental staff.
  • Types of Protective Devices: Covers requirements for protective filtering eyewear, handheld protective filters, and filters attached to polymerization devices.
  • Construction and Quality: Sets specifications for area protected, material and surface quality, field of view, and resistance to cleaning and disinfection protocols.
  • Testing Methods: Outlines standardized laboratory procedures for measuring spectral transmittance using spectrophotometric equipment, verification of apparatus accuracy, and protocols for validating filter performance.
  • Labeling and Documentation: Lists mandatory markings such as model number, manufacturer identification, and compliance with relevant standards, ensuring traceability and proper usage.
  • Packaging and Instructions: Details necessary packaging practices and the essential information to be included with instructions for use, such as cleaning procedures and warnings regarding improper use.

Applications

The oSIST prEN ISO 7260:2026:2026 standard is crucial for:

  • Dental Clinics: Ensuring the safety of both practitioners and patients during procedures that utilize powered polymerization activators for curing resin-based materials (fillings, cements, sealants, etc.).
  • Dental Equipment Manufacturers: Guiding the design, production, and quality assurance of filtering eyewear and shields to comply with blue light safety requirements.
  • Regulatory Compliance: Offering a harmonized reference for authorities requiring conformity of personal protective equipment (PPE) in dental environments.
  • Healthcare Providers: Supporting oral healthcare professionals in selecting and maintaining appropriate protective filtering devices to minimize occupational hazard from blue light exposure.
  • Procurement and Safety Officers: Assisting in the specification, evaluation, and approval of compliant safety products for dental practices.

Related Standards

  • ISO 10650:2018 – Dentistry - Powered polymerization activators
  • ISO 12609-1:2021 – Eye and face protection against intense light sources for cosmetic and medical applications
  • ISO 21530 – Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants
  • ISO 17664-1 & ISO 17664-2 – Processing of healthcare products - Information supplied by the manufacturer for medical device processing
  • CIE S 017 – International Lighting Vocabulary
  • ICNIRP Guidelines – Limits of exposure to incoherent visible and infrared radiation

Practical Value

By implementing oSIST prEN ISO 7260:2026:2026, dental practices and manufacturers ensure essential protection from the well-documented risks of blue light exposure during polymerization processes. This standard delivers robust, evidence-based guidance for the evaluation and selection of PPE, helps lower the incidence of eye injuries, enhances workplace safety, and ensures compliance with international dental equipment safety regulations.

Keywords: dentistry standards, protective filtering devices, blue light hazard, polymerization activators, dental safety, PPE, LED curing light, dental equipment compliance, ISO 7260, CEN standards, eye protection, dental curing lights

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Frequently Asked Questions

oSIST prEN ISO 7260:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Protective filtering devices intended for use with powered polymerization activators (ISO/DIS 7260:2026)". This standard covers: This document specifies requirements, test methods, and labeling for protective filtering devices intended for protection against retinal blue light exposure from powered polymerization activators in the scope of ISO 10650:2018, i.e., powered polymerization activators using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization. This document does not apply to protective filtering devices for lasers or plasma arc devices.

This document specifies requirements, test methods, and labeling for protective filtering devices intended for protection against retinal blue light exposure from powered polymerization activators in the scope of ISO 10650:2018, i.e., powered polymerization activators using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization. This document does not apply to protective filtering devices for lasers or plasma arc devices.

oSIST prEN ISO 7260:2026 is classified under the following ICS (International Classification for Standards) categories: 11.060.20 - Dental equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

oSIST prEN ISO 7260:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-maj-2026
Zobozdravstvo - Zaščitne filtrirne naprave namenjene za uporabo z električnimi
polimerizacijskimi aktivatorji (ISO/DIS 7260:2026)
Dentistry - Protective filtering devices intended for use with powered polymerization
activators (ISO/DIS 7260:2026)
Zahnheilkunde - Schutzfilter zur Verwendung mit elektrischen Polymerisationsgeräten
(ISO/DIS 7260:2026)
Médecine bucco-dentaire - Dispositifs de protection filtrants destinés à être utilisés avec
des activateurs électriques de polymérisation (ISO/DIS 7260:2026)
Ta slovenski standard je istoveten z: prEN ISO 7260
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 7260
ISO/TC 106/SC 6
Dentistry — Protective filtering
Secretariat: DIN
devices intended for use with
Voting begins on:
powered polymerization activators
2026-03-16
ICS: 11.060.20
Voting terminates on:
2026-06-08
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 7260:2026(en)
DRAFT
ISO/DIS 7260:2026(en)
International
Standard
ISO/DIS 7260
ISO/TC 106/SC 6
Dentistry — Protective filtering
Secretariat: DIN
devices intended for use with
Voting begins on:
powered polymerization activators
ICS: 11.060.20
Voting terminates on:
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: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7260:2026(en)
ii
ISO/DIS 7260:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Requirements . 2
4.1 Blue-light weighted transmittance .2
4.2 Construction of protective filtering eyewear .3
4.2.1 General .3
4.2.2 Area to be protected .3
4.2.3 Frames and lateral protection . .3
4.2.4 Material and surface quality .3
4.2.5 Field of view .3
4.3 Construction of handheld protective filters .3
4.3.1 Size .3
4.3.2 Material and surface quality .3
4.4 Construction of protective filters attached to powered polymerization activators .3
4.4.1 Material and surface quality .3
4.5 Processing .3
5  Sampling . 4
6  Measurement and test methods . 4
6.1 General .4
6.2 Test conditions .4
6.3 Transmittance and blue-light weighted transmittance measurements .4
6.3.1 Overview .4
6.3.2 Apparatus .5
6.3.3 Control filters .6
6.3.4 Test specimen .6
6.3.5 Verification of transmittance measurement accuracy .7
6.3.6 Blue-light weighted transmittance measurement .7
7  Marking . . 8
8  Packaging. 9
8.1 Packaging construction .9
8.2 Packaging information .9
9 Instructions for use . . 9
Annex A (informative)  Rationale for blue-light weighted transmittance requirement .10
Bibliography .15

iii
ISO/DIS 7260:2026(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, Subcommitee 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 is the first edition of this document.
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 7260:2026(en)
Introduction
Light emitted from powered polymerization activators may exceed limit values for photochemical retinal
exposure to visible (blue) light under certain circumstances. Exposure limit values are specified in ICNIRP
[1]
Guidelines on limits of exposure to incoherent visible and infrared radiation and applied in IEC 62471 .
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). Most
powered polymerization activators have emission spectra that match the absorbance spectrum of the
photoinitiator camphorquinone, characterized by an absorption maximum of 468 nm. Some curing lights
have more than one emission peak to match the absorption of other photoinitiators in the wavelength range
approximately from 380 nm to 420 nm.
Powered polymerization activators have relatively small emission surfaces, typically 5 mm to 12 mm
diameter, and high radiance values, up to 3000 times higher than that of LED sources for indoor lighting. The
combination of the spectral emission, high power and small size of powered polymerization activators poses
a risk of exceeding the limits specified for retinal blue light exposure.
Both patients and oral healthcare providers may be exposed to visible light from powered polymerization
activators. Exposure may be either direct or indirect (i.e. reflected or scattered).
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. Such protective
filtering devices can be in the form of protective filtering eyewear, handheld protective filters or protective
filters attached to powered polymerization activators.

v
DRAFT International Standard ISO/DIS 7260:2026(en)
Dentistry — Protective filtering devices intended for use with
powered polymerization activators
1 Scope
This document specifies requirements, test methods, and labeling for protective filtering devices intended
for protection against retinal blue-light hazard exposure in the wavelength range from 380 nm to 550 nm
from powered polymerization activators in the scope of ISO 10650, i.e. powered polymerization activators
using quartz-tungsten halogen lamps or light emitting diodes (LED) to activate polymerization.
This document does not apply to protective filtering devices for lasers or plasma arc devices.
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 12609-1:2021, Eye and face protection against intense light sources used on humans and animals for
cosmetic and medical applications — Part 1: Specification for products
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
ISO 17664-2, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18526-4, Eye and face protection — Test methods — Part 4: Headforms
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
CIE S 017, ILV: International Lighting Vocabulary
ICNIRP Guidelines on limits of exposure to incoherent visible and infrared radiation, International
Commission on Non-Ionizing Radiation Protection, Health Physics 105(1):74-96; 2013
International Commission on Non-Ionizing Radiation Protection (ICNIRP), ICNIRP Guidelines on limits of
exposure to incoherent visible and infrared radiation, Health Physics 105(1):74-96; 2013
3  Terms and definitions
For the purposes of this document, the terms and definitions given in CIE S 017 and ISO 1942 as well as the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp

ISO/DIS 7260:2026(en)
3.1
protective filtering device
optical element intended to protect the eye from incident radiation by attenuating that radiation, generally
within a given wavelength range
[2]
[SOURCE: ISO 4007:2018 , 3.10.1.1, modified ― "filter" replaced with "protective filtering device"; “lens”
replaced with “optical element”; Notes to entry removed]
3.2
powered polymerization activator
device producing a light beam primarily in the 380 to 515 nm region, intended for chairside use in
polymerizing polymer-based dental materials (e.g. filling, restorative and luting materials, cements, bonding
agents, sealants, primers)
[SOURCE: ISO 10650:2018, 3.6, modified ― expanded the range of applicable materials]
3.3
exposure limit value
maximum level of exposure of optical radiation to the eye or skin that is not expected to result in adverse
biological effects
[2]
[SOURCE: ISO 4007:2018 , 3.4.14, modified - Note 1 to entry removed]
3.4
blue-light hazard
potential for a photochemically induced retinal injury resulting from optical radiation exposure in the
wavelength range 300 nm to 700 nm
[2]
[SOURCE: ISO 4007:2018 , 3.1.7]
3.5
spectral transmittance
τ(λ)
ratio of the spectral radiant flux or luminous flux transmitted by the material to the incident spectral radiant
flux or luminous flux at any specified wavelength, λ, for a specified angle of incidence
[2]
[SOURCE: ISO 4007:2018 , 3.10.1.22]
3.6
blue-light weighted transmittance
τ
B
normalized value of the spectral transmittance averaged between 380 nm and 550 nm, weighted by the
blue-light hazard function
[2]
[SOURCE: ISO 4007:2018 , 3.10.1.36, modified — added “weighted” to the term and replaced 500 nm with
550 nm to encompass the entire wavelength range over which the blue-light hazard weighting function has
a value of > 0,01]
4  Requirements
4.1  Blue-light weighted transmittance
The blue-light weighted transmittance, τ , over the wavelength range from 380 nm to 550 nm of the
B
protective filtering device shall not exceed 5,0 %.
Test in accordance with 6.3.
NOTE Further information about the rationale for the limit specified in this subclause is provided in Annex A.

ISO/DIS 7260:2026(en)
4.2  Construction of protective filtering eyewear
4.2.1  General
If the protective filtering device is designed to be worn as eyewear (e.g. spectacles, goggles), then the
requirements of ISO 12609-1:2021, Clause 5.3 shall apply.
4.2.2  Area to be protected
ISO 12609-1:2021, 9.1 shall apply. Unless the manufacturer specifies the headform(s) (in accordance with
ISO 18526-4) that is/are compatible with the protective filtering eyewear, the headform 1-M per ISO 18526-4
shall be used as the default.
4.2.3  Frames and lateral protection
Frames and lateral protection through which exposure to incident optical radiation could occur to the eyes
shall provide at least the same level of protection as specified in 4.1 for the minimum area to be protected in
accordance with 4.2.2.
4.2.4  Material and surface quality
Except for a marginal area 5 mm wide, protective filtering eyewear shall be free from defects likely to impair
vision when in use (such as bubbles, scratches, inclusions, dull spots, pitting, mould marks, scouring, grains,
pocking, scaling and undulation) when visually inspected.
4.2.5  Field of view
ISO 12609-1:2021, 9.4 shall apply.
4.3  Construction of handheld protective filters
4.3.1  Size
The minimum size of the transparent protective filter area of the device, excluding the handle, shall be no
smaller than a circle having a diameter of 150 mm. The shape of the filter area is not restricted to being
circular.
4.3.2  Material and surface quality
Except for a marginal area 5 mm wide, filters shall be free from significant defects likely to impair vision
when in use (such as bubbles, scratches, inclusions, dull spots, pitting, mould marks, scouring, grains,
pocking, scaling and undulation) when visually inspected.
4.4  Construction of protective filters attached to powered polymerization activators
4.4.1  Material and surface quality
Except for a marginal area 5 mm wide, filters shall be free from defects likely to impair vision when in use
(such as bubbles, scratches, inclusions, dull spots, pitting, mould marks, scouring, grains, pocking, scaling
and undulation) when visually inspected. This requirement does not apply if the protective filter attached to
the powered polymerization activator is not intended to enable seeing the operating field through the filter.
4.5  Processing
Surfaces of the protective filtering device shall be suitable for processing using the protocol(s) recommended
by the manufacturer without deterioration of surfaces or marking.

ISO/DIS 7260:2026(en)
Test conformity of resistance against cleaning and disinfection in accordance with ISO 21530. In addition
to evaluating compliance with the inspection and evaluation criteria specified in ISO 21530, evaluate
compliance with the blue-light weighted transmittance requirement specified in 4.1 in accordance with 6.3
after completing the ISO 21530 test method.
5  Sampling
One representative protective filtering device shall be evaluated for conformance with the requirements
specified in this document.
6  Measurement and test methods
6.1  General
All tests described in th
...

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