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  • ISO 18385:2016

    Current The latest, up-to-date edition.

    Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  28-01-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.

    The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables.

    ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).

    ISO 18385:2016 excludes microbiological testing.

    ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.

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

    Development Note Supersedes ISO/DIS 18385. (02/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    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 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
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    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
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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