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  • BS 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Requirements and testing for biological evaluation

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-12-2023

    Language(s):  English

    Published date:  30-04-2015

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and 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 the measurements
            of natural rubber latex allergens
    Annex C (informative) - Amino acid analysis (AAA) by high
            pressure liquid chromatography (HPLC)
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EU Directive 93/42/EEC Medical Devices

    Abstract - (Show below) - (Hide below)

    Defines requirements for the evaluation of biological safety for medical gloves for single use. Also provides requirements for labelling and the disclosure of information relevant to the test methods used.

    Scope - (Show below) - (Hide below)

    This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

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

    Committee CH/205/3
    Development Note Together with BS EN 455-1 & BS EN 455-2 supersedes BS 4005(1996). Supersedes 96/563158 DC. (09/2005) Supersedes 13/30281504 DC. (04/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS 6183-4:2001 Protective equipment for cricketers Gloves for batsmen

    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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