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  • EN ISO 10650:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Dentistry - Powered polymerization activators (ISO 10650:2015)

    Available format(s): 

    Superseded date:  02-02-2019

    Language(s): 

    Published date:  30-09-2015

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Requirements
    6 Sampling
    7 Test methods
    8 Information to be supplied by the manufacturer
    9 Marking
    10 Packaging
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 10650:2015 specifies requirements and test methods for powered polymerization 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 internal 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.ISO 10650:2015 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 IEC 60601‑1 where specified in the individual clauses of this International Standard.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 55
    Development Note Supersedes EN ISO 10650-1 & EN ISO 10650-2. (10/2015)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-2-57:2011 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
    IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 1942:2009 Dentistry Vocabulary
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    ISO 9687:2015 Dentistry Graphical symbols for dental equipment
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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