SIST EN ISO 10650:2015
(Main)Dentistry - Powered polymerization activators (ISO 10650:2015)
Dentistry - Powered polymerization activators (ISO 10650:2015)
This International Standard specifies requirements and test methods for powered polymerization
activators in the 385 nm – 515 nm wavelength region intended for chairside use in polymerization of
dental polymer-based materials. This International Standard 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 International Standard.
This International Standard does not cover powered polymerization activators used in laboratory
fabrication of indirect restorations, veneers, dentures, or other oral dental appliances. This
International Standard takes priority over IEC 60601-1 where specified in the individual clauses of this
International Standard.
Zahnheilkunde - Polymerisationslampen (ISO 10650:2015)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Polymerisationslampen im Wellen-längenbereich von 400 nm bis 515 nm fest, die für die Anwendung am Patientenstuhl zur Polymerisation von Dentalwerkstoffen auf Kunststoffbasis vorgesehen sind. Diese Internationale Norm gilt für wiederaufladbare batteriebetriebene Quarz-Wolfram-Halogenlampen und Lumineszenzdiodenlampen (LED). Polymerisations-lampen können über eine eingebaute Energieversorgung (wiederaufladbare Batterie) verfügen oder an die externe Stromversorgung (Stromnetz) angeschlossen sein. Laser oder Plasmalichtbogengeräte werden von dieser Norm nicht erfasst.
Diese Internationale Norm gilt nicht für Polymerisationslampen, die im Dentallabor zur Herstellung von indirekten Restaurationen, Veneers, Prothesen oder anderen oralen Anwendungen verwendet werden. Wo das in den einzelnen Abschnitten dieser Internationalen Norm festgelegt ist, hat dieser Teil von ISO 10650 Vorrang vor IEC 60601-1:2005+A1:2012.
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2015)
ISO 10650:2015 spécifie les exigences et les méthodes d'essai relatives aux activateurs électriques de polymérisation, dans le domaine de longueur d'onde de 385 nm à 515 nm, destinés à être utilisés à proximité du fauteuil dentaire pour polymériser les matériaux dentaires à base de polymères. La présente Norme internationale 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 pile 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 internationale.
ISO 10650:2015 ne s'applique pas aux activateurs électriques de polymérisation utilisés en laboratoire pour la fabrication des restaurations indirectes, facettes, prothèses ou autres appareils buccaux. Partout où cela est spécifié dans ses différents articles, la présente Norme internationale a la priorité sur l'IEC 60601‑1.
Zobozdravstvo - Polimerizacijski aktivatorji (ISO 10650:2015)
Ta mednarodni standard določa zahteve in preskusne metode za polimerizacijske aktivatorje v območju valovne dolžine od 385 nm do 515 nm, ki so namenjeni za uporabo v ordinaciji za polimerizacijo zobozdravstvenih materialov na osnovi polimerov. Ta mednarodni standard velja 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 mednarodni standard ne zajema laserjev ali naprav s plazemskim oblokom.
Ta mednarodni standard ne zajema polimerizacijskih aktivatorjev, ki se uporabljajo pri laboratorijski
izdelavi posrednih preureditev, lusk, protez ali drugih ustnih zobnih aparatov. Ta mednarodni standard ima prednost pred standardom IEC 60601-1, kjer je to navedeno v posameznih točkah tega mednarodnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10650:2015
01-december-2015
1DGRPHãþD
SIST EN ISO 10650-1:2005
SIST EN ISO 10650-2:2008
Zobozdravstvo - Polimerizacijski aktivatorji (ISO 10650:2015)
Dentistry - Powered polymerization activators (ISO 10650:2015)
Zahnheilkunde - Polymerisationslampen (ISO 10650:2015)
Médecine bucco-dentaire - Activateurs électriques de polymérisation (ISO 10650:2015)
Ta slovenski standard je istoveten z: EN ISO 10650:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 10650:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10650:2015
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SIST EN ISO 10650:2015
EN ISO 10650
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 10650-1:2005, EN ISO 10650-
2:2007
English Version
Dentistry - Powered polymerization activators (ISO
10650:2015)
Médecine bucco-dentaire - Activateurs électriques de Zahnheilkunde - Polymerisationslampen (ISO
polymérisation (ISO 10650:2015) 10650:2015)
This European Standard was approved by CEN on 22 August 2015.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10650:2015 E
worldwide for CEN national Members.
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SIST EN ISO 10650:2015
EN ISO 10650:2015 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10650:2015
EN ISO 10650:2015 (E)
European foreword
This document (EN ISO 10650:2015) 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 10650-1:2005, EN ISO 10650-2:2007.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10650:2015 has been approved by CEN as EN ISO 10650:2015 without any modification.
3
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SIST EN ISO 10650:2015
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SIST EN ISO 10650:2015
INTERNATIONAL ISO
STANDARD 10650
First edition
2015-09-15
Dentistry — Powered polymerization
activators
Médecine bucco-dentaire — Activateurs électriques de polymérisation
Reference number
ISO 10650:2015(E)
©
ISO 2015
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SIST EN ISO 10650:2015
ISO 10650:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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Tel. +41 22 749 01 11
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copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 10650:2015
ISO 10650:2015(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 . 2
5.1.4 Cleaning, disinfection, and sterilization . 2
5.1.5 Excessive temperatures . 2
5.2 Radiant exitance . 3
5.2.1 Radiant exitance in the 385 nm to 515 nm (blue) wavelength region . 3
5.2.2 Radiant exitance in the 200 nm to 385 nm wavelength region . 3
5.2.3 Radiant exitance in the wavelength region above 515 nm . 3
5.3 Electrical safety requirements. 3
6 Sampling . 3
7 Test methods . 3
7.1 General . 3
7.1.1 General provisions for tests. 3
7.1.2 Atmospheric conditions . 4
7.2 Radiant exitance . 4
7.2.1 Apparatus . 4
7.2.2 Procedures . 6
7.2.3 Treatment of results. 9
8 Information to be supplied by the manufacturer .11
8.1 Instructions for use .11
8.2 Technical description .12
9 Marking .12
10 Packaging .12
Bibliography .14
© ISO 2015 – All rights reserved iii
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SIST EN ISO 10650:2015
ISO 10650:2015(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 the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This first edition of ISO 10650 cancels and replaces ISO 10650-1:2004 and ISO 10650-2:2007, which
have been technically revised with the following changes:
— limitation of blue wavelength region to: 200 nm to 385 nm;
— test procedure 7.2 radiant exitance was adopted to LED-diode lamps;
— information to be supplied by the manufacturer and marking requirements were updated.
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SIST EN ISO 10650:2015
ISO 10650:2015(E)
Introduction
This International Standard specifies requirements and test methods in the 200 nm to 385 nm
wavelength region and the wavelength region above 515 nm for powered polymerization activators.
No minimum requirement value is given for the 385 nm to 515 nm wavelength region. The value in the
385 nm to 515 nm wavelength region is no less than the manufacturer’s stated value.
This International Standard uses wavelength regions based on cut-off filters. Thus, the 200 nm to
385 nm region includes not only the ultraviolet region but also the near blue wavelength region of around
380 nm. The 385 nm to 515 nm region is taken as the region for powered polymerization activation.
The region above 515 nm reaches approximately 1100 nm, which is the detection limit of the detector
specified in this International Standard. The test methods described do not give absolute values nor do
they reflect energy emitted as black body radiation. The measured values are not true radiant exitance
but are values obtained using the methods described in this International Standard. Nevertheless, the
values obtained using these test methods are used in conjunction with this International Standard.
This International Standard refers to IEC 60601-1, the basic International Standard on safety of medical
electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 60601-1.
© ISO 2015 – All rights reserved v
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SIST EN ISO 10650:2015
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SIST EN ISO 10650:2015
INTERNATIONAL STANDARD ISO 10650:2015(E)
Dentistry — Powered polymerization activators
1 Scope
This International Standard specifies requirements and test methods for powered polymerization
activators in the 385 nm – 515 nm wavelength region intended for chairside use in polymerization of
dental polymer-based materials. This International Standard 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 International Standard.
This International Standard does not cover powered polymerization activators used in laboratory
fabrication of indirect restorations, veneers, dentures, or other oral dental appliances. This
International Standard takes priority over IEC 60601-1 where specified in the individual clauses of this
International Standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 9687, Dentistry — Graphical symbols for dental equipment
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
IEC 60601-1, 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 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for 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 and IEC 60601-1 apply.
NOTE The issue corresponds to IEC 60601-1:2005+A1:2012, Clause 3.
3.1
powered polymerization activator
device producing light primarily in the 385 nm to 515 nm region, intended for chairside use in
polymerizing polymer-based filling, restorative, and luting materials
3.2
light-emitting diode lamps
semiconductor-based light emitting lamps
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SIST EN ISO 10650:2015
ISO 10650:2015(E)
3.3
fully charged battery
battery which at the beginning is 100 % of the first full charge
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 diode (LED) lamps
Type 1: Polymerization activators powered with mains supply.
Type 2: Polymerization activators powered with rechargeable battery/capacitor.
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. IEC 60601-1:2005+A1:2012 applies.
5.1.2 Connection
Powered polymerization activators shall be capable of being disconnected and reconnected from the
supply for cleaning and disinfection.
Compliance shall be checked by manual inspection.
5.1.3 Operating controls
Operating controls shall be designed and located to minimize accidental activation.
Testing shall be carried out by visual and manual inspection.
5.1.4 Cleaning, disinfection, and sterilization
IEC 60601-1 applies.
The issue corresponds to IEC 60601-1:2005+A1:2012, 7.9.2.12.
5.1.5 Excessive temperatures
IEC 80601-2-60 applies.
NOTE The issue corresponds to IEC 80601-2-60:2012, 20
...
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