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 polymerbased
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

Status
Published
Public Enquiry End Date
19-Jun-2017
Publication Date
13-Nov-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Oct-2018
Due Date
27-Dec-2018
Completion Date
14-Nov-2018

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SLOVENSKI STANDARD
SIST EN ISO 10650:2018
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
SIST EN ISO 10650:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10650:2018
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SIST EN ISO 10650:2018
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.
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SIST EN ISO 10650:2018
EN ISO 10650:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 10650:2018
EN ISO 10650:2018 (E)
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.

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SIST EN ISO 10650:2018
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SIST EN ISO 10650:2018
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
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SIST EN ISO 10650:2018
ISO 10650:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 10650:2018
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 2018 – All rights reserved iii
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SIST EN ISO 10650:2018
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 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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www .iso .org/iso/foreword .html.

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

equipment.

This second edition cancels and replaces the first edition (ISO 10650:2015), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— a test procedure using spectrometer (Method A, 7.4.1) was included;
— a test procedure using filters (Method B, 7.4.2) was modified;

— an upper limit to the radiant exitance for the 380 nm to 515 nm wavelength region was added.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 10650:2018
ISO 10650:2018(E)
Introduction

This document specifies requirements and test methods in the wavelength region below 380 nm,

the 380 nm to 515 nm wavelength region and the wavelength region above 515 nm for powered

polymerization activators. No minimum requirement value is given for the 380 nm to 515 nm

wavelength region. For the 380 nm to 515 nm wavelength region, the maximum radiant exitance has

been specified in order to mitigate risks for patients.

There is a risk of tissue damage caused by heat development during photo-polymerization when

sufficiently high irradiances are applied for long enough time. There is a risk of inadequate

polymerization of resin-based materials when irradiated by powered polymerization activators with

high radiant exitance for very short irradiation time resulting in insufficient combinations of irradiance

and irradiation time. There is also a risk of inadequate polymerization of resin-based materials when

irradiated with low irradiance and short irradiation time. There is no complete reciprocity between

irradiance and curing time, i.e. a time threshold exists under which the polymerization will not proceed

sufficiently. Therefore it is important to follow the instructions for use of the composite manufacturers.

This document refers to IEC 60601, the basic International Standard on safety of medical electrical

equipment, wherever relevant, by stating the respective clause numbers of IEC 60601.

© ISO 2018 – All rights reserved v
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SIST EN ISO 10650:2018
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SIST EN ISO 10650:2018
INTERNATIONAL STANDARD ISO 10650:2018(E)
Dentistry — Powered polymerization activators
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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
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

ISO 17664, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices

IEC 60601-1:2005+AMD1: 2012, 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 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

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, IEC 60601-1 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
© ISO 2018 – All rights reserved 1
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SIST EN ISO 10650:2018
ISO 10650:2018(E)
3.1
powered polymerization activator

device producing a light beam primarily in the 380 nm to 515 nm region, intended for chairside use in

polymerizing polymer-based filling, restorative and luting materials
3.2
light-emitting diode (LED) lamps
semiconductor-based light emitting lamps
3.3
fully charged battery
battery which at the beginning of the testing is 100 % of the first full charge
3.4
radiant exitance

quotient of the radiant flux leaving an element of the surface containing the point, by the area of

the element
3.5
irradiance

quotient of the radiant flux incident on an element of the surface containing the point, by the area of

the element
3.6
radiant flux
power emitted, transmitted or received in the form of radiation
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 wit
...

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