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  • BS ISO 13408-7 : 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2015

    Language(s):  English

    Published date:  01-01-2012

    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 Aseptic process definition
    6 Manufacturing environment
    7 Equipment
    8 Personnel
    9 Manufacture of the product
    10 Process simulation
    11 Test for sterility
    Annex A (informative) - Risk assessment for aseptic
            processing - Quality risk management method
    Annex B (informative) - Selection of a sample for testing
            for microbial contamination
    Annex C (informative) - Testing options for process
            simulation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.

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

    Committee CH/198
    Development Note Renumbered and superseded by BS EN ISO 13408-7. (08/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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