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    I.S. EN 455-4:2009

    Current The latest, up-to-date edition.

    MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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
                          shelf life by real time stability
                          studies
    Annex B (informative) - Guidance on conducting and
                            analyzing accelerated ageing
                            studies
    Annex C (informative) - Determination of the shelf life
                            of a significantly modified
                            product
    Annex ZA (informative) - Relationship between this
                             European Standard and the
                             Essential Requirements of EU
                             Directive 93/42/EEC Medical
                             Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for shelf life for medical gloves for single use.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 2578:1993 Plastics Determination of time-temperature limits after prolonged exposure to heat
    ISO 11346:2014 Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use
    EN ISO 2578 : 1998 PLASTICS - DETERMINATION OF TIME-TEMPERATURE LIMITS AFTER PROLONGED EXPOSURE TO HEAT
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 291:2008 Plastics Standard atmospheres for conditioning and testing
    EN ISO 291:2008 Plastics - Standard atmospheres for conditioning and testing (ISO 291:2008)
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