oSIST prEN ISO 10650:2025

Dentistry - Powered polymerization activators (ISO/DIS 10650:2025)

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.

Zahnheilkunde- Polymerisationslampen (ISO/DIS 10650:2025)

Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO/DIS 10650:2025)

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 s'applique aux lampes halogènes au tungstène à quartz et aux lampes à diodes électroluminescentes (LED). Les activateurs électriques de polymérisation peuvent avoir une alimentation électrique interne (à batterie rechargeable) ou être raccordés à une alimentation électrique externe (secteur). Les dispositifs à lasers ou à arc plasma ne sont pas couverts par la présente norme.
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/DIS 10650:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Apr-2025
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 27-Feb-2025
• Due Date: 17-Jul-2025
• Ref Project: prEN ISO 10650 - Dentistry - Powered polymerization activators (ISO/DIS 10650:2025)

Relations

• Revises: SIST EN ISO 10650:2018 - Dentistry - Powered polymerization activators (ISO 10650:2018)
• Effective Date: 30-Oct-2024

Standards Content (Sample)

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.
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)
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
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
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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equi
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