EN ISO 10650-1:2005
(Main)Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)
Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)
ISO 10650-1:2004 specifies requirements and test methods for powered polymerization activators in the blue wavelength region intended for chair-side use in polymerization of dental polymer-based materials. ISO 10650-1:2004 applies to powered tungsten-halogen lamps and rechargeable battery-powered tungsten-halogen polymerization activators.
ISO 10650-1:2004 is not applicable to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances. ISO 10650-1:2004 takes priority over IEC 60601-1:1988 where specified in the individual clauses of this International Standard.
Zahnheilkunde - Lichtpolymerisationsgeräte - Teil 1: Quartz-Wolfram-Halogenlampen (ISO 10650-1:2004)
Art dentaire - Activateurs électriques de polymérisation - Partie 1: Lampes halogènes au tungstène à quartz (ISO 10650-1:2004)
L'ISO 10650-1:2004 spécifie les exigences et les méthodes d'essai applicables aux activateurs électriques de polymérisation dans le domaine de longueur d'onde du bleu destinés à être utilisés à proximité du fauteuil dentaire pour polymériser les produits à base de polymère dentaire. L'ISO 10650-1:2004 s'applique aux lampes électriques halogènes au tungstène et activateurs électriques de polymérisation halogènes au tungstène à pile rechargeable.
L'ISO 10650-1:2004 ne s'applique pas aux activateurs électriques de polymérisation utilisés en laboratoire pour la fabrication des restaurations indirectes, incrustations, prothèses ou autres appareils buccaux. Partout où cela est spécifié dans ses différents articles, l'ISO 10650-1:2004 a la priorité sur la CEI 60601-1:1988.
Zobozdravstvo – Polimerizacijski aktivatorji – 1. del: Halogenske svetilke »Quartz tungsten« (ISO 10650-1:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2005
Zobozdravstvo – Polimerizacijski aktivatorji – 1. del: Halogenske svetilke »Quartz
tungsten« (ISO 10650-1:2004)
Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps
(ISO 10650-1:2004)
Zahnheilkunde - Lichtpolymerisationsgeräte - Teil 1: Quartz-Wolfram-Halogenlampen
(ISO 10650-1:2004)
Art dentaire - Activateurs électriques de polymérisation - Partie 1: Lampes halogenes au
tungstene a quartz (ISO 10650-1:2004)
Ta slovenski standard je istoveten z: EN ISO 10650-1:2005
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10650-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2005
ICS 11.060.20
English Version
Dentistry - Powered polymerization activators - Part 1: Quartz
tungsten halogen lamps (ISO 10650-1:2004)
Art dentaire - Activateurs électriques de polymérisation - Zahnheilkunde - Lichtpolymerisationsgeräte - Teil 1:
Partie 1: Lampes halogènes au tungstène à quartz (ISO Quartz-Wolfram-Halogenlampen (ISO 10650-1:2004)
10650-1:2004)
This European Standard was approved by CEN on 4 September 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10650-1:2005: E
worldwide for CEN national Members.
Foreword
The text of ISO 10650-1:2004 has been prepared by Technical Committee ISO/TC 106
"Dentistry” of the International Organization for Standardization (ISO) and has been taken over
as EN ISO 10650-1:2005 by 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 2006, and conflicting national
standards shall be withdrawn at the latest by April 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 10650-1:2004 has been approved by CEN as EN ISO 10650-1:2005 without any
modifications.
INTERNATIONAL ISO
STANDARD 10650-1
First edition
2004-11-01
Dentistry — Powered polymerization
activators —
Part 1:
Quartz tungsten halogen lamps
Art dentaire — Activateurs électriques de polymérisation —
Partie 1: Lampes halogènes au tungstène à quartz
Reference number
ISO 10650-1:2004(E)
©
ISO 2004
ISO 10650-1:2004(E)
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ii © ISO 2004 – All rights reserved
ISO 10650-1:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification. 1
5 Requirements . 2
5.1 General. 2
5.2 Radiant exitance. 2
5.3 Electrical requirements . 3
6 Sampling . 3
7 Test methods. 3
7.1 General. 3
7.2 Radiant exitance. 4
8 Information to be supplied by the manufacturer . 17
8.1 Instructions for use. 17
8.2 Technical description . 17
9 Marking. 18
Annex A (normative) Sequence of testing . 19
ISO 10650-1:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10650-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This first edition of ISO 10650-1 together with ISO 10650-2 cancels and replaces ISO/TS 10650:1999, which
has been technically revised.
ISO 10650 consists of the following parts, under the general title Dentistry — Powered polymerization
activators:
Part 1: Quartz tungsten-halogen lamps
The following part is under preparation:
Part 2: Light-emitting diode (LED) lamps
iv © ISO 2004 – All rights reserved
ISO 10650-1:2004(E)
Introduction
This International Standard specifies requirements and test methods for powered polymerization activators in
the 190 nm to 385 nm wavelength region and the wavelength region above 515 nm. No requirement is given
for the 400 nm to 515 nm wavelength region. This International Standard uses wavelength regions based on
cut-off filters. Thus, the 190 nm to 385 nm region includes not only the ultraviolet region but also the near-blue
wavelength region of around 380 nm. The 400 nm to 515 nm region is taken as the blue region for powered
polymerization activation. The region above 515 nm reaches approximately 1 100 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 60601-1:1988, the basic International Standard on safety of medical
electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 60601-1:1988.
INTERNATIONAL STANDARD ISO 10650-1:2004(E)
Dentistry — Powered polymerization activators —
Part 1:
Quartz tungsten halogen lamps
1 Scope
This part of ISO 10650 specifies requirements and test methods for powered polymerization activators in the
blue wavelength region intended for chair-side use in polymerization of dental polymer-based materials. This
part of ISO 10650 applies to powered tungsten-halogen lamps and rechargeable battery-powered tungsten-
halogen polymerization activators.
This Part of ISO 10650 is not applicable to powered polymerization activators used in laboratory fabrication of
indirect restorations, veneers, dentures or other oral dental appliances. This part of ISO 10650 takes priority
over IEC 60601-1:1988 where specified in the individual clauses of this International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
Standard: Electromagnetic compatibility — Requirements and test
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and IEC 60601-1:1988,
Clause 2, and the following apply.
3.1
powered polymerization activator
device for producing light in the blue wavelength region, intended for chair-side use in polymerizing polymer-
based filling, restorative and luting materials
4 Classification
For the purposes of this part of ISO 10650, powered polymerization activators are classified, according to their
power supply, as follows:
Type 1: polymerization activators powered with a mains supply;
Type 2: polymerization activators powered with a rechargeable battery supply.
ISO 10650-1:2004(E)
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 should be ca
...
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