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    I.S. EN ISO 13408-2:2018

    Current The latest, up-to-date edition.

    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2018

    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)

    National Foreword
    European foreword
    Endorsement notice
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
    5 Sterilizing filter characterization
    6 Process and equipment characterization
    7 Fluid definition
    8 Process definition
    9 Validation
    10 Routine monitoring and control
    11 Product release from sterilizing filtration
    12 Maintaining process effectiveness
    Annex A (informative) - Guidance on the application
            of this document
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 90/385/EEC
             on active implantable medical devices
             [OJ L 189] aimed to be covered
    Annex ZB (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC on
             medical devices [OJ L 169] aimed to be covered
    Annex ZC (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 98/79/EC on in vitro diagnostic
             medical devices [OJ L 331] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Defines requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1.

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

    Development Note Supersedes I.S. EN 13824. (07/2011)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

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

    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
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