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  • 14/30289934 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-02-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Definitions and abbreviations
    4 Types of products
    5 Quality systems
    6 Contamination prevention in manufacturing
    7 Quality assurance and monitoring of manufacturing
      environments
    8 Post-production treatment of products
    9 Product packaging, labelling and documentation
    Annex A (normative) - Compliance testing
    Annex B (informative) - Methods currently used for
            postproduction treatment and its effects on DNA
    Bibliography

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

    Comment Closes On
    Committee FSM/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    ISO 14644-8:2013 Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
    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 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 31000:2009 Risk management Principles and guidelines
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    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 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
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