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  • UNI EN ISO 13408-5 : 2011

    Current The latest, up-to-date edition.

    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE

    Available format(s): 

    Language(s): 

    Published date:  14-09-2011

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
    5 Process and equipment characterization
    6 Sterilizing agent characterization
    7 SIP process
    8 Validation
    9 Routine monitoring and control
    10 Personnel training
    Annex A (informative) - Steam sterilization in place
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 90/385/EEC on Active Implantable
             Medical Devices
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC on Medical Devices
    Annex ZC (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 98/79/EC on in vitro diagnostic medical
             devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the general requirements for sterilization in place (SIP) applied to product contact surfaces of the 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 CT 44
    Development Note Supersedes UNI EN 13824. (10/2011)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    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 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
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    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
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    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
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