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  • DIN EN ISO 13408-7:2015-11

    Current The latest, up-to-date edition.

    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)

    Available format(s):  Hardcopy, PDF

    Language(s):  German, English

    Published date:  01-01-2015

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    European 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
    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)

    This standard is included in DIN Handbook 406.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    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
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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