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

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.”

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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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