EN ISO 10650:2018
(Main)Dentistry - Powered polymerization activators (ISO 10650:2018)
Dentistry - Powered polymerization activators (ISO 10650:2018)
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 10650:2018)
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2018)
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 10650:2018)
Ta dokument določa zahteve in preskusne metode za polimerizacijske aktivatorje v območju valovne dolžine od 380 nm do 515 nm, ki so namenjeni za uporabo v ordinaciji za polimerizacijo zobozdravstvenih materialov na osnovi polimerov.
Ta dokument se uporablja za halogenske svetilke »Quartz tungsten« in svetilke s svetlečimi diodami (LED). Polimerizacijski aktivatorji imajo lahko notranje napajanje (napajanje prek polnilne baterije) ali so povezani z zunanjim napajalnim omrežjem. Ta standard ne zajema laserjev ali naprav s plazemskim oblokom.
Ta dokument ne zajema polimerizacijskih aktivatorjev, ki se uporabljajo pri laboratorijski izdelavi posrednih preureditev, lusk, protez ali drugih ustnih zobnih aparatov.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2018
1DGRPHãþD
SIST EN ISO 10650:2015
Zobozdravstvo - Polimerizacijski aktivatorji (ISO 10650:2018)
Dentistry - Powered polymerization activators (ISO 10650:2018)
Zahnheilkunde - Polymerisationslampen (ISO 10650:2018)
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2018)
Ta slovenski standard je istoveten z: EN ISO 10650:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10650
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 10650:2015
English Version
Dentistry - Powered polymerization activators (ISO
10650:2018)
Médecine bucco-dentaire - Activateurs électriques de Zahnheilkunde - Polymerisationslampen (ISO
polymérisation (ISO 10650:2018) 10650:2018)
This European Standard was approved by CEN on 21 July 2018.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10650:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10650:2018) 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 April 2019, and conflicting national standards shall be
withdrawn at the latest by April 2019.
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 10650:2015.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10650:2018 has been approved by CEN as EN ISO 10650:2018 without any modification.
INTERNATIONAL ISO
STANDARD 10650
Second edition
2018-08
Dentistry — Powered polymerization
activators
Médecine bucco-dentaire — Activateurs électriques de polymérisation
Reference number
ISO 10650:2018(E)
©
ISO 2018
ISO 10650:2018(E)
© ISO 2018
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ISO 10650:2018(E)
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 . 3
5.1.4 Cleaning, disinfection and sterilization . 3
5.1.5 Excessive temperatures . 3
5.2 Radiant exitance . 3
5.2.1 Radiant exitance in the 380 nm to 515 nm wavelength region . 3
5.2.2 Radiant exitance in the wavelength region below 380 nm . 3
5.2.3 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
ISO 10650:2018(E)
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).
Attention is drawn to the possibility that some of t
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