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ISO INTERNATIONAL STANDARD. Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps - PDF Free Download
ISO INTERNATIONAL STANDARD. Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps
Download "ISO INTERNATIONAL STANDARD. Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps"
Evelyn Cain
1 Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO First edition Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps Art dentaire Activateurs électriques de polymérisation Partie 2: Lampes à diodes émettrices de lumière (LED) Reference number ISO :2007(E) ISO 2007
2 ISO :2007(E) Provläsningsexemplar / Preview PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel Fax Web Published in Switzerland ii ISO 2007 All rights reserved
3 Provläsningsexemplar / Preview ISO :2007(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 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. This first edition, together with ISO , cancels and replaces ISO/TS 10650:1999, which has been technically revised. ISO consists of the following parts, under the general title Dentistry Powered polymerization activators: Part 1: Quartz tungsten halogen lamps Part 2: Light-emitting diode (LED) lamps ISO 2007 All rights reserved iii
4 ISO :2007(E) Provläsningsexemplar / Preview Introduction This part of ISO specifies requirements and test methods for light emitting diodes (LED) type powered polymerization activators in the 190 nm to 385 nm wavelength region and the wavelength region above 515 nm. No requirements are 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 nm, which is the detection limit of the detector specified in this document. 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 document. Nevertheless, the values obtained using these test methods are used in conjunction with this document. This part of ISO refers to IEC :2005, the basic International Standard on safety of medical electrical equipment, wherever relevant, by stating the respective clause numbers of IEC :2005. iv ISO 2007 All rights reserved
5 Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO :2007(E) Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps 1 Scope This part of ISO specifies requirements and test methods for powered polymerization activators with light-emitting diodes (LED) in the blue wavelength region intended for chair-side use in polymerization of dental polymer-based restorative materials. This part of ISO 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 takes priority over IEC :2005 where specified in the individual clauses of this part of ISO 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 ISO :2004, Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps IEC :2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO , IEC and the following apply. 3.1 light-emitting diode (LED) lamp semiconductor-based light emitting source 3.2 fully charged battery battery which has at the beginning a charge of 80 % to 100 % of the first full charge 4 Classification For the purposes of this document, powered polymerization activators with light emitting diodes are classified as specified in ISO ISO 2007 All rights reserved 1
6 ISO :2007(E) Provläsningsexemplar / Preview 5 Requirements 5.1 General ISO :2004, 5.1 applies. Test the LED lamps at each continuous irradiation mode or pulse mode of 10 s or longer stated by the manufacturer. 5.2 Radiant exitance Radiant exitance in the 400 nm to 515 nm (blue) wavelength region This part of ISO does not specify a requirement value for the radiant exitance in the 400 nm to 515 nm (blue) wavelength region. The manufacturer shall provide information on the radiant exitance in the 400 nm to 515 nm region as determined by the test method described in 7.2. The radiant exitance in the 400 nm to 515 nm region shall be not less than the manufacturer s stated value when tested in accordance with and 7.2.2, at the stated operating voltage. For Type 2 polymerization activators with light-emitting diodes, an initially fully-charged powered polymerization activator shall be tested for compliance with this requirement Radiant exitance in the 190 nm to 385 nm wavelength region The radiant exitance in the 190 nm to 385 nm region shall be no more than W/m 2 (200 mw/cm 2 ) when tested in accordance with and 7.2.2, at the stated operating voltage. For Type 2 polymerization activators with light-emitting diodes, an initially fully-charged powered polymerization activator shall be tested for compliance with this requirement Radiant exitance in the wavelength region above 515 nm The radiant exitance in the wavelength region above 515 nm shall be no more than W/m 2 (100 mw/cm 2 ) when tested in accordance with and 7.2.2, at the stated operating voltage. For Type 2 polymerization activators with light-emitting diodes, an initially fully-charged powered polymerization activator shall be tested for compliance with this requirement. 5.3 Electrical requirements ISO :2004, 5.3 applies. 6 Sampling ISO :2004, Clause 6 applies. 7 Test methods 7.1 General ISO :2004, 7.1 applies. Measurements of the LED lamp shall be performed at each continuous irradiation mode or pulse mode of 10 s or longer stated by the manufacturer. 2 ISO 2007 All rights reserved
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