• PD ISO/TR 13014:2012

    Current The latest, up-to-date edition.

    Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-12-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Symbols and abbreviated terms
    4 Importance of physico-chemical properties to
      toxicological assessment
    5 Parameters for the physico-chemical characterization
      of manufactured nano-objects prior to
      toxicological assessment
    6 Expression of measurement results and uncertainties
    7 Reporting
    Annex A (informative) - Diagram illustrating the use of
            physico-chemical characterization in
            toxicological testing
    Annex B (informative) - Example measurement methods
            and standards
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for the physico-chemical characterization of manufactured nano-objects and their aggregates and agglomerates (NOAA) greater than 100 nm presented for toxicological testing in order to aid in assessing and interpreting the toxicological impact of manufactured nano-objects and to allow the material under test to be differentiated from seemingly similar materials.

    Scope - (Show below) - (Hide below)

    This Technical Report provides guidance for the physico-chemical characterization of manufactured nano- objects and their aggregates and agglomerates (NOAA) greater than 100nm presented for toxicological testing in order to aid in assessing and interpreting the toxicological impact of manufactured nano-objects and to allow the material under test to be differentiated from seemingly similar materials. For each of the selected properties, a description, clarification, relevance, measurand and example measurement methods are provided.

    This Technical Report will be of value to parties (e.g. toxicologists, ecotoxicologists, regulators, health and safety professionals) interested in assessing and interpreting the potential toxicological effect of manufactured NOAAs.

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

    Committee NTI/1
    Document Type Standard
    Publisher British Standards Institution
    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 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    ISO/TS 27687:2008 Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate
    ISO 1942-2:1989 Dental vocabulary Part 2: Dental materials
    ISO 8780-1:1990 Pigments and extenders — Methods of dispersion for assessment of dispersion characteristics — Part 1: Introduction
    ISO 7579:2009 Dyestuffs — Determination of solubility in organic solvents — Gravimetric and photometric methods
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 3252:1999 Powder metallurgy Vocabulary
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 472:2013 Plastics Vocabulary
    ISO 1213-1:1993 Solid mineral fuels Vocabulary Part 1: Terms relating to coal preparation
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 6141:2015 Gas analysis Contents of certificates for calibration gas mixtures
    ISO 6107-6:2004 Water quality Vocabulary Part 6:
    ISO 9276-6:2008 Representation of results of particle size analysis — Part 6: Descriptive and quantitative representation of particle shape and morphology
    ISO Guide 34:2009 General requirements for the competence of reference material producers
    ISO 21501-1:2009 Determination of particle size distribution — Single particle light interaction methods — Part 1: Light scattering aerosol spectrometer
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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