SIST EN ISO 10650-1:2005

Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)

This standard gives requrirements and test methods for polymerization activators with powered tungsten-halogen lamps in the blue wavelength region intended for chairside use in polymerization of dental resin-based materials. This standard is also applicable to recharchable battery-powered polymerization activators.
It does not cover powered polymerization activators used in dental laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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)

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

• Status: Withdrawn
• Publication Date: 30-Nov-2005
• Withdrawal Date: 01-Nov-2015
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 30-Oct-2015
• Due Date: 22-Nov-2015
• Completion Date: 02-Nov-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 10650-1:2005 - Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)

Relations

• Replaced By: SIST EN ISO 10650:2015 - Dentistry - Powered polymerization activators (ISO 10650:2015)
• Effective Date: 07-Oct-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10650-1:2005
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
SIST EN ISO 10650-1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10650-1:2005

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SIST EN ISO 10650-1:2005
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 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.

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SIST EN ISO 10650-1:2005
EN ISO 10650-1:2005 (E)






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.

2

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SIST EN ISO 10650-1:2005


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

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SIST EN ISO 10650-1:2005
ISO 10650-1:2004(E)
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©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 10650-1:2005
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 2004 – All rights reserved iii

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SIST EN ISO 10650-1:2005
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

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SIST EN ISO 10650-1:2005
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.

© ISO 2004 – All rights reserved v

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SIST EN ISO 10650-1:2005

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SIST EN ISO 10650-1:2005
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 2004 – All rights reserved 1

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SIST EN ISO 10650-1:2005
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 capable of being easily disassembled and
reassembled for maintenance and repair, using readily available tools or those supplied by the manufacturer.
IEC 60601-1:1988, Clause 59 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 inspection
5.1.4 Cleaning and disinfection
IEC 60601-1:1988, Clause 44.7 applies.
5.1.5 Excessive temperatures
IEC 60601-1:1988, Clause 42 applies.
5.2 Radiant exitance
5.2.1 Radiant exitance in the 400 nm to 515 nm (blue) wavelength region
This International Standard does not specify a requirement for the radiant exitance in the 400 nm to 515 nm
(blue) wavelength region. The manufacturer shall provide information on the radiant exitance in this region as
determined by the test method in 7.2. The radiant exitance in the 400 nm to 515 nm region shall not be less
than the manufacturer's stated value when tested in accordance with 7.2. For Type 2 polymerization activators,
the requirement applies only to a fully charged powered polymerization activator.
5.2.2 Radiant exitance in the 190 nm to 385 nm wavelength region
2 2
The radiant exitance in the 190 nm to 385 nm region shall be no more than 2 000 W/m (200 mW/cm ) at the
operating voltage, 90 % of the operating voltage and 110 % of the operating voltage when tested in
accordance with 7.2. For Type 2 polymerization activators, the requirement applies only to a fully charged
powered polymerization activator.
5.2.3 Radiant exitance in the wavelength region above 515 nm
2
The radiant exitance in the wavelength region above 515 nm shall be no more than 1 000 W/m
2
(100 mW/cm ) at the operating voltage, 90 % of the operating voltage and 110 % of the operating voltage
when tested in accordance with 7.2. For Type 2 polymerization activators, the requirement applies only to a
fully charged powered polymerization activator.
2 © ISO 2004 – All rights reserved

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SIST EN ISO 10650-1:2005
ISO 10650-1:2004(E)
5.3 Electrical requirements
The requirements for the following equipment and conditions are governed by the cited clauses and/or
subclauses of IEC 60601:
a) power input IEC 60601-1:1988, Clause 7;
b) single-fault conditions IEC 60601-1:1988, 3.6 and Clause 52;
c) protection against electric shock hazards IEC 60601-1:1988, Clause 13;
d) enclosures and protective covers IEC 60601-1:1988, Clause 16;
e) leakage IEC 60601-1:1988, 44.4;
f) protective earthing IEC 60601-1:1988, Clause 58;
g) continuous leakage currents IEC 60601-1:1988, Clause 19;
h) dielectric strength IEC 60601-1:1988, Clause 20;
i) interruption of the power supply IEC 60601-1:1988, Clause 49;
j) abnormal operating and fault conditions IEC 60601-1:1988, Clause 52;
k) components and general assembly IEC 60601-1:1988, Clause 56;
l) mains parts, components and assembly IEC 60601-1:1988, Clause 57;
m) electromagnetic compatibility IEC 60601-1-2.
6 Sampling
At least one powered polymerization activator, with a light guide (optic tip) as specified by the manufacturer for
each model series, shall be evaluated for compliance with this International Standard.
7 Test methods
7.1 General
7.1.1 General provisions for tests
The sequence of tests shall be in accordance with Annex A.
All tests described in this International Standard are type tests. Type tests shall be made on one
representative sample of the item being tested.
IEC 60601-1:1988, 4.1 and 4.2 apply.
Unless otherwise specified, do not repeat any of these tests.
© ISO 2004 – All rights reserved 3

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SIST EN ISO 10650-1:2005
ISO 10650-1:2004(E)
7.1.2 Atmospheric conditions
After the powered polymerization activator being tested has been set up for normal use, tests shall be carried
out under the following conditions:
a) ambient temperature of (23 ± 2) °C;
b) relative humidity of (50 ± 10) %.
7.1.3 Other conditions
IEC 60601-1:1988, 4.6 d) applies.
7.1.4 Supply and test voltages, type of current, nature of supply, frequency
IEC 60601-1:1988, 4.7 applies.
7.1.5 Preconditioning
IEC 60601-1:1988, 4.8 applies.
7.1.6 Conditioning
The test arrangement and the powered polymerization activator shall be conditioned in an environment at
(23 ± 2) °C for 4 h before testing.
7.1.7 Repairs and modifications
IEC 60601-1:1988, 4.9 applies.
7.2 Radiant exitance
7.2.1 Apparatus
7.2.1.1 Apparatus for measuring the optical cross-sectional area of the optic tip
7.2.1.1.1 Micrometer, reading in millimetres, with an accuracy to 0,02 mm, or any other measuring device
with an equivalent accuracy.
7.2.1.2 Apparatus for measuring the irradiance
7.2.1.2.1 Radiometer, calibrated, used to measure the radiated power (in watts).
The radiometer shall have a flat response (uniform spectral sensitivity) within the wavelength region from
1)
190 nm to 1 100 nm, independent of the angle of radiation incidence .
The entrance aperture of the radiometer shall be larger than the cross-section of the optic tip of the powered
polymerization activator, so that all radiant emission is measured by the radiometer. The edge of the optic tip
should be at least 2 mm from the edge of the entrance aperture.

1) Molectron Power Meter PM 500D-2 and Molectron Detector PM-3 are the trade n
...