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    I.S. EN ISO 13408-6:2021

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Aseptic processing of health care products - Part 6: Isolator systems

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-07-2021

    Language(s):  English

    Published date:  16-06-2021

    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 Quality system elements
    5 Basic principle of isolator systems
    6 Isolator system specification
    7 Design of isolator systems
    8 Validation
    9 Routine monitoring and control
    10 Personnel training
    Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
    Annex B (informative) Isolator system — Explanation of terms used and flow of air and
    material
    Annex C (informative) Isolator system — Direct/indirect product contact surfaces
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies the requirements for and provides guidance on the specification, selection,
    qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.

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

    Committee TC 198
    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    Status Superseded
    Superseded By
    Supersedes
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