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  • ONORM EN 455-3 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION

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    Superseded date:  20-01-2024

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    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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    Abstract - (Show below) - (Hide below)

    Dieser Teil der EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er enthält Anforderungen für die Kennzeichnung und die Angaben von Informationen über die angewendeten Prüfmethoden. Diese ÖNORM legt Prüfverfahren für die Biokompatibilität und Anforderungen an die Kennzeichnung der Biokompatibilität medizinischer Handschuhe zum einmaligen Gebrauch fest. Diese Norm enthält ebenfalls einen Überblick über immunologische Verfahren für die Bestimmung löslicher Proteine und Allergene.

    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    Status Superseded
    Superseded By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 13718-2 : 2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

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

    ONORM EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ONORM EN ISO 10993-10 : 2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ONORM EN ISO 10993-1 : 2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 21171:2006 Medical gloves — Determination of removable surface powder
    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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