News & Analysis as of

International Organization for Standardization Manufacturers

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

Bergeson & Campbell, P.C.

ISO Publishes Standard Evaluating Methods for Assessing the Release of Nanomaterials from Commercial, Nanomaterial-Containing...

The International Organization for Standardization (ISO) has published ISO/TR 22293:2021, “Evaluation of methods for assessing the release of nanomaterials from commercial, nanomaterial-containing polymer composites.” ISO...more

Bergeson & Campbell, P.C.

NIOSH Publishes One-Pager on Nanotechnology Research Center’s Accomplishments and Future Activities

On August 20, 2019, the National Institute for Occupational Safety and Health (NIOSH) posted a one-pager on the Nanotechnology Research Center (NTRC). NTRC conducts research to understand the potential effects on human health...more

Bergeson & Campbell, P.C.

ISO Guidance Specifies Characteristics and Measurement Methods for Antibacterial Silver Nanoparticles

The International Organization for Standardization (ISO) has published standard ISO/TS 20660:2019, “Nanotechnologies — Antibacterial silver nanoparticles — Specification of characteristics and measurement methods.” ...more

Bergeson & Campbell, P.C.

ISO Issues Method to Quantify Air Concentrations of Carbon Black and Amorphous Silica in the Nanoparticle Size Range in a Mixed...

The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range...more

Bergeson & Campbell, P.C.

ISO Publishes Standard on Considerations for the Measurement of Nano-Objects and Their Aggregates and Agglomerates in...

The International Organization for Standardization (ISO) has published standard ISO/TR 21386, “Nanotechnologies — Considerations for the measurement of nano-objects and their aggregates and agglomerates (NOAA) in...more

Bergeson & Campbell, P.C.

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...more

Bergeson & Campbell, P.C.

ISO Publishes Standard on Aquatic Toxicity Assessment of Manufactured Nanomaterials in Saltwater Lakes

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia...more

Bergeson & Campbell, P.C.

ISO Publishes Standard Terms and Definitions for Cellulose Nanomaterial

The International Organization for Standardization (ISO) has published standard ISO/TS 20477:2017, “Nanotechnologies — Standard terms and their definition for cellulose nanomaterial.” The standard states that in industrial...more

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