ASTM President Meets with Standards Officials in Asia

In February, ASTM International President Andrew Kireta visited Asia to meet with multiple standards-related organizations. A summary of acitivities follows.

Singapore

In Singapore, Kireta signed an agreement for ASTM to develop a joint standard in robotics with Enterprise Singapore, which has been an ASTM memorandum of understanding (MoU) partner since 2003. This collaboration will synergize the two organizations’ mutual expertise and efforts in the robotics realm.

Also in Singapore, Kireta gave opening remarks at a hybrid event, “Standards and Innovation in Additive Manufacturing,” in partnership with National Additive Manufacturing Innovation Cluster (NAMIC) Singapore. Kireta also visited A*STAR’s Advanced Remanufacturing and Technology Centre (ARTC) and Additive Innovation Centre (AIC), organizations with which ASTM has a close partnership.

Korea

In Korea, Kireta, along with Teresa Cendrowska, vice president, global cooperation with ASTM, met with Young-gil Cheon and the aerospace team at Korea Conformity Laboratories (KCL). ASTM and KCL anticipate increased collaboration regarding information exchange in the areas of aerospace and unmanned aircraft systems.

While in Korea, Kireta, Cendrowska, and Elvin Chia, ASTM’s director of outreach in Asia, met with Kwang Hae Oh, acting administrator of the Korean Agency for Technology and Standards. Topics of mutual interest to ASTM and KATS were discussed, including Korea-hosted APEC meetings, the International Summit on AI, ASTM’s “Standardization Impact Report,” and the recently awarded Standardization Center of Excellence (SCoE).

KATS and ASTM have been MoU partners since 2006.

Japan

During Kireta’s visit to Japan, he discussed the role of standards in innovation and standardization workforce development with staff from the New Energy and Industrial Technology Development Organization’s Technology and Innovation Center and the Ministry of Economy, Trade and Industry’s Innovation and Environmental Policy Bureau.

U.S. FDA Recognizes ASTM Test Method

The United States Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has formally recognized ASTM International’s standard test method for measuring the size of nanoparticles in aqueous media using dynamic light scattering (E3247) in its Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, also known as the CDER Quality Standards Program.

The test method was developed by ASTM’s nanotechnology committee (E56). Technical lead Vince Hackley of the National Institute of Standards and Technology (NIST), along with a task group, worked closely with critical stakeholders to achieve the final consensus document. Experts from across multiple FDA centers and the FDA Nanotechnology Task Force, chaired by Anil Patri, engaged with E56 to ensure the standard met regulatory needs and requirements.

The CDER Quality Standards Program “communicate(s) to external stakeholders that FDA experts have evaluated a consensus standard and determined that the standard is potentially useful to industry and FDA staff.” The test method was previously recognized in full by the FDA Standards Recognition Program administered by the Center for Devices and Radiological Health (CDRH).

Recognition by the CDRH program is the process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act.

FDA recognition validates the work of the committee and the important role that E56 plays in supporting the safe and effective development of nanotechnology-based medical products. Recognized standards are directly beneficial to industry, as they establish a clear pathway for regulatory submission and approval and provide confidence in measurement data.

On Feb. 12, Jeff Grove, ASTM’s vice president of global policy and communications, spoke at the NATO Use of Civil Standards Workshop in Athens, Greece. Grove discussed ASTM’s role as a NATO partner organization and its work to strengthen the NATO alliance through standards.

In February, James Olshefsky, ASTM International’s head of global outreach, traveled to Dubai to participate as one of the welcoming speakers at the American Concrete Institute’s (ACI) Middle East Conference. A great opportunity to highlight the longstanding partnership between ASTM and ACI, the conference afforded ASTM the opportunity to further foster relationships in the construction sector in the region.