Standards

 

In building scientific data for regulatory and other approvals, recognized and standardised protocols are essential. Materials at the nanoscale in several cases need different experimental conditions and these may not be reflected in current standards for a material at bulk scale.

  • The OECD has had a long process considering global consensus on documentation and new characterization and test requirements for manufactured nanomaterials. See more about the OECD Working Party on Manufactured Nanomaterials (http://www.oecd.org/science/nanosafety/) and OECD Guidance and Guidelines (http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm).

  • Standardization bodies including ISO (The International Standardization Organization) and CEN (The European Committee for Standardization) are undertaking actions to make new and update existing standards and technical specifications. See more at the CEN (https://standards.cen.eu/) and ISO (https://www.iso.org/store.html).


Internationally approved Standards, Technical Guidelines and Guidance Documents gives better confidence to regulators across the globe. This allows enables mutual acceptance of data (MAD) and greater confidence for testing of nanomaterials by producers and users and data provided for market access. However, these processes are often long and transferring new techniques and methods developed in laboratories for standardization requires strong coordination among different scientists and regulators around the world.


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