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  • BS ISO 18362:2016

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Manufacture of cell-based health care products. Control of microbial risks during processing

    Available format(s): 

    Withdrawn date:  07-02-2023

    Language(s): 

    Published date:  31-01-2016

    Publisher:  British Standards Institution

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

    Foreword
    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 sterilit
    Annex A (informative) - Examples of microbial risks for CBHP
    Annex B (normative) - Decision trees for application of risk
            assessment for cell-based 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

    Abstract - (Show below) - (Hide below)

    Defines the minimum requirements for, and gives guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination.

    Scope - (Show below) - (Hide below)

    This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled \'sterile\' and to CBHPs not labelled \'sterile\'.

    This International Standard is not applicable to:

    • procurement and transport of cell-based starting material used in processing of a CBHP,

    • cell banking,

    • control of genetic material,

    • control of non-microbial product contamination,

    • in vitro diagnostics (IVDs), or

    • natural medicines.

    EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.

    This International Standard does not define biosafety containment requirements.

    This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

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

    Committee CH/198
    Development Note Supersedes 14/30266295 DC. (02/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    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 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    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 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    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 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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