BS EN ISO 10650-2015 Dentistry Powered polymerization activators《牙科学 动力聚合活化剂》.pdf

1、BSI Standards PublicationBS EN ISO 10650:2015Dentistry Poweredpolymerization activatorsBS EN ISO 10650:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 10650:2015. It supersedes BS EN ISO 10650-1:2005 and BS EN ISO 10650-2:2007 which are withdrawn.The UK

2、 participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract.

3、 Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 83218 5 ICS 11.060.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the autho

4、rity of the Standards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN 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 Dentis

5、try - Powered polymerization activators (ISO 10650:2015) Mdecine bucco-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

6、/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 Cen

7、tre 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 th

8、e 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, Nether

9、lands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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 righ

10、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10650:2015 EBS EN ISO 10650:2015EN ISO 10650:2015 (E) 3 European foreword This document (EN ISO 10650:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration wi

11、th 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 withdr

12、awn 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

13、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 Macedoni

14、a, 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

15、 EN ISO 10650:2015 without any modification. BS EN ISO 10650:2015ISO 10650:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 General . 25.1.1 Design 25.1.2 Connection 25.1.3 Operating controls 25.1.4 Cleaning, disinfec

16、tion, and sterilization . 25.1.5 Excessive temperatures . 25.2 Radiant exitance 35.2.1 Radiant exitance in the 385 nm to 515 nm (blue) wavelength region 35.2.2 Radiant exitance in the 200 nm to 385 nm wavelength region . 35.2.3 Radiant exitance in the wavelength region above 515 nm 35.3 Electrical s

17、afety requirements. 36 Sampling 37 Test methods . 37.1 General . 37.1.1 General provisions for tests 37.1.2 Atmospheric conditions 47.2 Radiant exitance 47.2.1 Apparatus . 47.2.2 Procedures 67.2.3 Treatment of results 98 Information to be supplied by the manufacturer 118.1 Instructions for use 118.2

18、 Technical description . 129 Marking .1210 Packaging 12Bibliography .14 ISO 2015 All rights reserved iiiContents PageBS EN ISO 10650:2015ISO 10650:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The w

19、ork 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-govern

20、mental, 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 t

21、he 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 poss

22、ibility 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 o

23、f 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

24、information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the 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

25、 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 marki

26、ng requirements were updated.iv ISO 2015 All rights reservedBS EN ISO 10650:2015ISO 10650:2015(E)IntroductionThis 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

27、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 manufacturers stated value.This International Standard uses wavelength regions based on cut-off filters. Thus, the 200 nm to 385 nm region includes n

28、ot 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 In

29、ternational 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 obta

30、ined 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 A

31、ll rights reserved vBS EN ISO 10650:2015BS EN ISO 10650:2015Dentistry Powered polymerization activators1 ScopeThis 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

32、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

33、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

34、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 document and are indispensable for its application. For dated references, only the edition cited applies. For un

35、dated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 9687, Dentistry Graphical symbols for dental equipmentISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be suppl

36、ied 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 electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibilit

37、y 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 the purposes of this document, the terms and definitions given in ISO 1942 and IEC 60601-1 apply.NOTE The is

38、sue 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 polymerizing polymer-based filling, restorative, and luting materials3.2light-emitting diode lampssemiconductor-base

39、d light emitting lampsINTERNATIONAL STANDARD ISO 10650:2015(E) ISO 2015 All rights reserved 1BS EN ISO 10650:2015ISO 10650:2015(E)3.3fully charged batterybattery which at the beginning is 100 % of the first full charge4 ClassificationPowered polymerization activators are classified, according to the

40、ir 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) lampsType 1: Polymerization activators powered with m

41、ains 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, the powered polymerization activator shall be capab

42、le 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 being disconnected and reconnected from the supply f

43、or 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 606

44、01-1 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, 201.11.1.2 ISO 2015 All rights reservedBS EN ISO 10650:2015ISO 10650:2015(E)5.2 Radiant exitanceThe requirements for radiant

45、exitance shall be met when tested at each continuous irradiation mode or pulse mode time period as specified by the manufacturer. If no time period is specified, the time period shall be 10 s.5.2.1 Radiant exitance in the 385 nm to 515 nm (blue) wavelength regionThis International Standard does not

46、specify a requirement value for the radiant exitance in the 385 nm to 515 nm wavelength region. The manufacture shall provide information on the radiant exitance in this region as determined by the test method in 7.2. The radiant exitance in the 385 nm to 515 nm region shall not be less than the man

47、ufacturers stated value at 90 %, 100 %, and 110 % of the operating voltage for Class 1 Type 1 and Class 2 Type 1. For Type 2 polymerization activators, the requirement applies only to a fully charged powered polymerization activator.5.2.2 Radiant exitance in the 200 nm to 385 nm wavelength regionThe

48、 radiant exitance in the 200 nm to 385 nm regions shall be no more than 2 000 W/m2(200 mW/cm2) for Class 1 Type 1 and Class 2 Type 1 at 90 %, 100 % and 110 % of the operating voltage when tested in accordance with 7.2. For Class 1 Type 2 and Class 2 Type 2 polymerization activators, the requirement

49、applies only to a fully charged powered polymerization activator.5.2.3 Radiant exitance in the wavelength region above 515 nmThe radiant exitance in the wavelength region above 515 nm shall be no more than 1 000 W/m2(100 mW/c m2) at the operating voltage for Class 1 Type 1 and Class 2 Type 1 at 90 %, 100 % and 110 % of the operating voltage when tested in accordance with 7.2. For Class 1 Type 2 and Class 2 Type 2 polymerization activators, the requirement applies only to a fully charged powered polymerization activator.5.3 El