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  • ANSI/AAMI/ISO 13408-4:2005(R2014)

    Current The latest, up-to-date edition.

    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  13-10-2014

    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 ANSI/AAMI adoption
    of ISO 13408-4:2005
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
    5 Process and equipment characterization
    6 Cleaning agent characterization
    7 CIP process
    8 Validation
    9 Routine monitoring and control
    10 Personnel training
    Annex A (informative) - Description of
            sampling methods
    Annex B (informative) - Calculation examples
            for acceptance criteria
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

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

    Committee WG 09
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
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