1、February 2016 English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.20!%LS(“2414805www.din.d
2、eDIN EN ISO 10650Dentistry Powered polymerization activators (ISO 10650:2015);English version EN ISO 10650:2015,English translation of DIN EN ISO 10650:2016-02Zahnheilkunde Polymerisationslampen (ISO 10650:2015);Englische Fassung EN ISO 10650:2015,Englische bersetzung von DIN EN ISO 10650:2016-02Mde
3、cine bucco-dentaire Activateurs lectriques de polymrisation (ISO 10650:2015);Version anglaise EN ISO 10650:2015,Traduction anglaise de DIN EN ISO 10650:2016-02SupersedesDIN EN ISO 10650-1:2006-01 andDIN EN ISO 10650-2:2007-11www.beuth.deDocument comprises 23 pagesDTranslation by DIN-Sprachendienst.I
4、n case of doubt, the German-language original shall be considered authoritative.03.16DIN EN ISO 10650:2016-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 10650:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical C
5、ommittee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committees NA 014-00-01 AA Fllungswerkstoffe and NA 014-00-01-04 AK Lichtpolymerisationsgerte. The DIN Stand
6、ards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 9687 DIN EN ISO 9687 ISO 15223-1 DIN EN ISO 15223-1 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750-1-2) IEC 62471 DIN EN 62471 (VD
7、E 0837-471) Amendments This standard differs from DIN EN ISO 10650-1:2006-01 and DIN EN ISO 10650-2:2007-11 as follows: a) the blue wavelength region has been limited to 200 nm to 385 nm; b) the test procedure described in 7.2 “Radiant exitance” has been adapted to LED-diode lamps; c) the informatio
8、n to be supplied by the manufacturer and the marking requirements have been updated. Previous editions DIN EN ISO 10650-1: 2006-01 DIN EN ISO 10650-2: 2007-11 DIN EN ISO 10650:2016-02 3 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: Gen
9、eral requirements for basic safety and essential performance DIN EN 60601-1-2 (VDE 0750-1-2), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 62471 (VDE 0837-471),
10、Photobiological safety of lamps and lamp systems DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 9687, Dentistry Graphical symbols for dental instruments DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requi
11、rements DIN EN ISO 10650:2016-02 4 Page intentionally left blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10650 September 2015 ICS 11.060.20 Supersedes EN ISO 10650-1:2005,EN ISO 10650-2:2007English Version Dentistry - Powered polymerization activators (ISO 10650:2015) Mdecine bucco-
12、dentaire - Activateurs lectriques de polymrisation (ISO 10650:2015) Zahnheilkunde - Polymerisationslampen (ISO 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
13、 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 offici
14、al 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 A
15、ustria, 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, Sw
16、eden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for
17、CEN national Members. Ref. No. EN ISO 10650:2015 EContents Page Foreword .4Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Classification 75 Requirements 75.1 General .75.1.1 Design 75.1.2 Connection 75.1.3 Operating controls 75.1.4 Cleaning, disinfection, and steriliza
18、tion . 75.1.5 Excessive temperatures . 75.2 Radiant exitance 85.2.1 Radiant exitance in the 385 nm to 515 nm (blue) wavelength region 85.2.2 Radiant exitance in the 200 nm to 385 nm wavelength region . 85.2.3 Radiant exitance in the wavelength region above 515 nm 85.3 Electrical safety requirements.
19、 86 Sampling 87 Test methods . 87.1 General . 87.1.1 General provisions for tests 87.1.2 Atmospheric conditions 97.2 Radiant exitance 97.2.1 Apparatus . 97.2.2 Procedures . 117.2.3 Treatment of results. 148 Information to be supplied by the manufacturer 168.1 Instructions for use 168.2 Technical des
20、cription . 179 Marking .1710 Packaging 17Bibliography .19European foreword .32 EN ISO 10650:2015 (E) DIN EN ISO 10650:2016-02European 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 “Dentis
21、try” 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. Attenti
22、on 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-CENEL
23、EC 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, Ice
24、land, 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 modificat
25、ion. 3EN ISO 10650:2015 (E)DIN EN ISO 10650:2016-02ForewordISO (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
26、 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 Internationa
27、l 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 t
28、ypes 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 b
29、e 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 inform
30、ation 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 ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the
31、 following URL: Foreword - Supplementary informationThe 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 follo
32、wing 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.4 EN ISO 10650:2015 (E) DIN EN ISO 10650:2016-02IntroductionThis Internati
33、onal 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
34、 region is no less than the manufacturers 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 ta
35、ken 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 bo
36、dy 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 t
37、o IEC 60601-1, the basic International Standard on safety of medical electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 60601-1.5EN ISO 10650:2015 (E)DIN EN ISO 10650:2016-021 ScopeThis International Standard specifies requirements and test methods for powered p
38、olymerization 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 inte
39、rnal 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 resto
40、rations, 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 referencesThe following documents, in whole or in part, are normatively referenced in this doc
41、ument 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 VocabularyISO 9687, Dentistry Graphical symbols for dental equipmentISO
42、15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance + Amendment 1:2012IEC 60601-1-2, Medical elec
43、trical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility Requirements and testIEC 80601-2-60, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment3 Terms and definitionsFor
44、 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 3.3.1powered polymerization activatordevice producing light primarily in the 385 nm to 515 nm region, intended for chairside use in polymer
45、izing polymer-based filling, restorative, and luting materials3.2light-emitting diode lampssemiconductor-based light emitting lamps6 EN ISO 10650:2015 (E) DIN EN ISO 10650:2016-023.3fully charged batterybattery which at the beginning is 100 % of the first full charge4 ClassificationPowered polymeriz
46、ation activators are classified, according to their lamps and power supply, as follows:Class 1: Quartz-tungsten-halogen lampsType 1: Polymerization activators powered with mains supply.Type 2: Polymerization activators powered with rechargeable battery supply.Class 2: Light-emitting diode (LED) lamp
47、sType 1: Polymerization activators powered with mains supply.Type 2: Polymerization activators powered with rechargeable battery/capacitor.5 Requirements5.1 General5.1.1 DesignThe construction of powered polymerization activators shall provide for safe and reliable operation. If field-repairable, th
48、e 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 ConnectionPowered polymerization activators shall be capable of bei
49、ng disconnected and reconnected from the supply for cleaning and disinfection.Compliance shall be checked by manual inspection.5.1.3 Operating controlsOperating 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 sterilizationIEC 60601-1 applies.The issue corresponds to IEC 60601-1:2005+A1:2012, 7.9.2.12.5.1.5 Excessive temperaturesIEC 80601-2-60 applies.NOTE The issue corresponds to IEC 80601-2-60:2012
