ISO INTERNATIONAL STANDARD 10650 Second edition 2018-08 Dentistry Powered polymerization activators Médecine bucco-dentaire - Activateurs électriques de polymérisation Reference number IS0 10650:2018(E) so International Organization for Standardization =Shenzhen Institute of Standards and Technology 9972181 @IS02018 ards Bodies Not for Resale, 2018/11/23 08:50:33 IS0 10650:2018(E) COPYRIGHTPROTECTEDDOCUMENT @IS02018 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 below or Iso's member body in the country of the requester. ISO copyright office CP 401·Ch.deBlandonnet8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ganizationfor Standardization icensee-Shenzhen Instte of Standards andecIS0g&- All rights reserved rious National Standards Bodies Not for Resale, 2018/11/23 08:50:33 IS0 10650:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 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 exitancein the380nm to515nm 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.. 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 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 .5 Apparatus. 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 ntemaional ganzationS2All rights reserved iii ee=Shenzhen Institute of Standards and Technology 9972181 Tanoutlicensena Not for Resale, 2018/11/23 08:50:33