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December 17, 2018

ISO Publishes Specification for Developing Representative Test Materials Consisting of Nano-Objects in Dry Powder Form

Lynn L. Bergeson Carla N. Hutton

In December 2018, the International Standardization Organization (ISO) published standard SO/TS 16195:2018, “Nanotechnologies — Specification for developing representative test materials consisting of nano-objects in dry powder form.”  The standard specifies development of representative test materials consisting of nano-objects in dry powder form to enable test method development and improve comparability of data for nanotechnology applications.  The standard specifies that for dry powders of nano-objects, the following minimum information be gathered and provided in a verification report to qualify the material as a nanoscale representative test material:

  • Information describing the manufacturing process;
  • Information on the quality management of its manufacturing process;
  • Data from physico-chemical measurements representing the principal features of the representative test material; and
  • Data on the stability and homogeneity of the above parameters.

ISO states that conformity to the standard, expressed in the form of a verification report, “will provide a level of assurance that the representative test material is homogeneous, statistically representative of the manufacturing process, and has stability.”  This will increase the likelihood that measurements that are undertaken on the representative test material are comparable across testing laboratories, “even for properties for which methods are being developed and for which homogeneity and stability have not been quantitatively assessed.”