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  • AAMI ISO 13408-6:2005

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  19-07-2015

    Language(s):  English

    Published date:  01-01-2013

    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 13408-6:2005
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
       4.1 General
       4.2 Management responsibility
       4.3 Design control
       4.4 Measuring instruments and measuring systems
    5 Design of isolator systems
       5.1 General
       5.2 Types of isolators
       5.3 Materials of construction
       5.4 Air-handling system
       5.5 Operator interface
       5.6 Ancillary equipment
    6 Facility requirements
       6.1 Surrounding room classification
       6.2 Process utilities
    7 User requirements
       7.1 Product/process application
       7.2 Ergonomics
       7.3 Cleaning
       7.4 Bio-decontamination
    8 Validation
       8.1 General
       8.2 Design qualification
       8.3 Installation qualification
       8.4 Operational qualification
       8.5 Performance qualification
       8.6 Review and approval of validation
       8.7 Requalification
    9 Routine monitoring and control
       9.1 Procedures
       9.2 System integrity
       9.3 Bio-decontamination process monitoring
       9.4 Environmental monitoring
       9.5 Change control
       9.6 Maintenance and calibration
    10 Personnel training
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

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

    Committee WG 09
    Document Type Standard
    Product Note Reconfirmed 2005
    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
    IEST RP CC006.2 : 1997 TESTING CLEANROOMS
    ISO 10648-1:1997 Containment enclosures — Part 1: Design principles
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems — Requirements
    ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    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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