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  • ONORM EN ISO 10993-10 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

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    Superseded date:  28-07-2023

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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    Abstract - (Show below) - (Hide below)

    Dieser Teil der Norm beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihrer Bestandteile hinsichtlich des Hervorrufens einer Irritation und einer Allergie vom verzögerten Typ. Es sind enthalten: a) vor der Prüfung durchzuführende Überlegungen; b) die Durchführung der Prüfung; c) Schlüsselfaktoren bei der Auslegung der Ergebnisse.

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

    Committee TC 179
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ONORM EN 14683 : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
    ONORM EN 455-3 : 2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION

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

    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
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