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  • AAMI ISO 13408-2 : 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: STERILIZING FILTRATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-04-2018

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO 13408-2:2018
    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 Annex A of this document
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes 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)

    Document Type Standard
    Product Note Reconfirmed 2003
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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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