• I.S. EN ISO 8871-3:2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICALS USE - PART 3: DETERMINATION OF RELEASED-PARTICLE COUNT

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-04-2019

    Language(s):  English

    Published date:  23-07-2004

    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 Determination of visible-particle count
    4 Determination of subvisible-particle count
    Bibliography

    Abstract - (Show below) - (Hide below)

    Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.

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

    Committee TC 76
    Development Note Supersedes I.S. EN ISO 8871 (08/2004)
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Superseded

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

    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
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