• NEN 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): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

    Sorry this product is not available in your region.

    Add To Cart

    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 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.

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

    Development Note Draft AMD 1 2016 issued on November 2016. (01/2017)
    Document Type Standard
    Publisher Netherlands Standards
    Status Current
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective