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  • 14/30266295 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-01-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    0 Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
    5 Process definition
    6 Manufacturing environment
    7 Equipment
    8 Personnel
    9 Manufacture of product
    10 Process simulation and process confirmation
    11 Finished product release: test for sterility
    12 Finished product release: testing for biological
       contamination that cannot be detected by the
       test for sterility
    Annex A (informative) - Examples of specific risks for CBHP
    Annex B (normative) - Decision trees for application of risk
            assessment for starting materials
    Annex C (informative) - Containment facilities
    Annex D (normative) - CBHP starting material
    Annex E (normative) - Containment requirements
            for procured, non-sterile starting materials
            before entering the manufacturing area
    Annex F (informative) - Typical elements of a process definition
    Bibliography

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

    Comment Closes On
    Committee CH/198
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By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 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
    AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    CFR 16(PTS1000-END) : 0 COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 29463-1:2017 High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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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