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    I.S. EN 17141:2020

    Current The latest, up-to-date edition.

    Cleanrooms and associated controlled environments - Biocontamination control

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-08-2020

    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)

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Establishment of microbiological control
    5 Demonstration of microbiological control
    6 Microbiological measurement methods
    Annex A (informative) Guidance for life science pharmaceutical and biopharmaceutical applications
    Annex B (informative) Guidance for life science medical device applications
    Annex C (informative) Guidance for healthcare/hospital applications
    Annex D (informative) Guidance for food applications
    Annex E (informative) Guidance on culture based microbiological measurement methods and sampler verification
    Annex F (informative) Rapid microbiological methods (RMM) and alternative real time microbiological detection methods (AMMs)
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments.

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

    Committee TC 243
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. This standard also refers to PDA TR 33: 2013
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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