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  • UNE-EN 455-3:2015

    Current The latest, up-to-date edition.

    Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  03-06-2015

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    5 Test methods
    6 Test report
    Annex A (normative) method for the determination of aqueous
                        extractable proteins in natural rubber
                        gloves using the modified Lowry assay
    Annex B (informative) Immunological methods for determination
                          of leachable proteins and allergens
                          from medical gloves
    Annex C (informative) Amino acid analysis (AAA) by high
                          pressure liquid chromatography (HPLC)
    Annex D (informative) Glossary
    Annex E (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
                           addressing essential requirements and
                           other provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Defines requirements for evaluating biological safety for single use medical gloves.

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

    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    ASTM D 5712 : 2015 : REDLINE Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    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
    ASTM D 7427 : 2016 : REDLINE Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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