ISO releases new standard

Recently, ISO has new developments, releasing new standards for nanotechnology determining particle size and shape distribution, medical device graphical symbol standards, low-speed automated driving system standards, etc. The latest ISO updates are summarized as follows:

ISO releases new nanotechnology standard determining particle size and shape distribution

The International Organization for Standardization (ISO) recently released a standard that provides important guidelines in the field of nanotechnology, especially regarding the use of scanning electron microscopes (SEMs): ISO 19749:2021 "Nanotechnology — Measurement of particle size and shape distribution by scanning electron microscopy."

Measuring the particle size and shape of nanoparticles is crucial for understanding their performance and potential applications in many fields. This international standard details data collection and analysis using scanning electron microscopy (SEM) to determine the size and shape of nanoparticles, with highly reproducible results. SEM produces images by scanning a focused electron beam over the surface and transmitting various signals indicating how electrons in the beam interact with the material, providing important information about the surface composition and morphology. SEM is indispensable and widely applied in many research, development, and manufacturing fields, including nanotechnology.

The new standard covers two morphological attributes of discrete and aggregated nano-objects (materials with at least one dimension in the nanoscale, i.e., between 1 nm and 100 nm) — size and shape. Additionally, the ISO standard will be widely applied because many scanning electron microscopes (SEMs) are used worldwide, making it an indispensable "main force" for nanoscale measurements.

ISO 19749 was developed by the second joint working group (JWG2) on "Measurement and Characterization" of ISO/TC229 "Nanotechnology" technical committee. The project was led by Dr. Andras Vladar (USA) from NIST and Dr. Tomoshige Sato (Japan) from JEOL, with significant contributions from international experts from France, Germany, Japan, and Mexico.

Vladimir Murashov, chair of the ANSI-recognized counterpart ISO/TC 229 "Nanotechnology" technical committee, said: "With the release of ISO 19749:2021, the US counterpart ISO TC 229 Technical Advisory Group (TAG) continues to lead the development of foundational standards that rigorously describe the two most fundamental characteristics of nanoparticles — size and shape. These foundational standards are necessary to further advance research and development, with the ultimate goal of unlocking the enormous potential of nanotechnology to address the world's most pressing challenges."

This standard complements ISO 21363 "Nanotechnology — Measurement of particle size and shape distribution by transmission electron microscopy," published in 2020 and led by the late Dr. Eric Grulke.

ISO releases standard on graphical symbols for medical devices

Information marked on medical devices must be correctly understood by all supply chain participants using different languages, regardless of the language they speak. Therefore, a set of internationally recognized graphical symbols is required. ISO has just revised the international standard defining these symbols.

ISO 15223-1 "Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements" is a globally applicable standard for outer packaging and internal supplementary information of various medical devices. ISO has just revised this standard, modifying definitions and descriptions and including some new symbols to meet various regulatory requirements.

For medical device manufacturers trading with other countries, this standard ensures consistency in conveying information and eliminates ambiguity. This standard is also useful for consumers of imported medical devices, improving their understanding and ensuring they are fully informed when choosing products.

ISO 15223-1 was developed by ISO/TC 210 — "Quality management and related aspects for medical devices" technical committee, with the secretariat held by ANSI, the US member of ISO.

ISO releases standard on low-speed automated driving systems

Low-speed automated driving (LSAD) systems offer opportunities to reduce congestion and carbon emissions in cities, thereby contributing to net-zero goals and many United Nations Sustainable Development Goals. Designed to operate on predefined routes in low-speed environments, they are typically used in commercial, business, or university campuses.

However, the development of this technology has been hindered by the lack of international standards defining performance and safety requirements — until now. To address this, ISO has just released a new standard to help accelerate progress safely and sustainably.

ISO 22737 "Intelligent transport systems — Low-speed automated driving (LSAD) systems on predefined routes — Performance requirements, system requirements and performance test procedures" provides a common language to facilitate the development and safe deployment of this technology worldwide.

Dr. Siddartha Khastgir, project leader of the expert group developing this standard, stated that the increased use of low-speed automated driving (LSAD) systems will lead to changes in the transportation of people, goods, and services.

"By defining minimum requirements and test procedures for low-speed automated driving systems, this new standard will enable the safe development of this environmentally friendly transportation option."

ISO 22737 was developed by ISO/TC 204 "Intelligent transport systems" technical committee, with the secretariat held by ANSI, the US member of ISO.