By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchIn April 2018, the International Standardization Organization (ISO) published standard ISO 19007:2018, “Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles.” The standard specifies a method for evaluating the effects of nano-objects and their aggregates and agglomerates on cellular viability using the MTS assay. The assay design includes performance requirements and… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials. The Testing Program for the Testing of Manufactured Nanomaterials tested 11 manufactured nanomaterials to generate information, including their… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchIn 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 sp. Nauplii.” ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp.… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchIn October 2017, the International Organization for Standardization (ISO) published standard ISO/TR 19057:2017, “Nanotechnologies — Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability.” The standard reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe International Organization for Standardization (ISO) has published standard ISO/TS 80004-13:2017, “Nanotechnologies — Vocabulary — Part 13: Graphene and related two-dimensional (2D) materials.” According to ISO, over the last decade, interest has arisen in graphene due to its “many exceptional properties.” More recently, other materials with a similar structure have also shown promising properties, including… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,ResearchThe 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 productions, cellulose nanomaterials can be manufactured by conversion of wood pulp through chemical, biological, or mechanical processes. Due to their renewable nature and unique properties, cellulose nanomaterials have… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe International Organization for Standardization (ISO) recently published standard ISO/TR 19601:2017, “Nanotechnologies — Aerosol generation for air exposure studies of nano-objects and their aggregates and agglomerates (NOAA).” ISO states that, to evaluate the inhalation toxicity of NOAA, it is important to consider certain parameters that make the toxicity testing relevant to human exposure. Three critical… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe International Organization for Standardization (ISO) published standard ISO/TR 18401:2017, “Nanotechnologies — Plain language explanation of selected terms from the ISO/IEC 80004 series.” The standard is intended to assist stakeholders who are making decisions about the direction, management, and application of nanotechnologies to understand better selected key terms and definitions in the ISO/IEC 80004 vocabulary… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe International Organization for Standardization (ISO) recently announced publication of standard ISO/TS 18827:2017, “Nanotechnologies — Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials.” The introduction states that the use of metal or metal oxide-based nanomaterials has dramatically increased in biomedical and industrial applications. The scientific… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in InternationalIn January 2017, the International Organization for Standardization (ISO) published International Electrotechnical Commission (IEC)/Technical Specification (TS) 80004-9:2017, “Nanotechnologies — Vocabulary — Part 9: Nano-enabled electrotechnical products and systems.” IEC/TS 80004-9:2017 specifies terms and definitions for electrotechnical products and systems reliant on nanomaterials for their essential functionalities. ISO states that it is intended to facilitate communications… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Occupational Health and Safety IssuesOn November 21, 2016, the International Organization for Standardization (ISO) released ISO/TR 18637:2016, “Nanotechnologies — Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs).” ISO notes that occupational exposure limits (OEL) are generally substance-specific. In some case, there is insufficient data to develop… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in ResearchThe International Organization for Standardization (ISO) recently published ISO/TR 18196:2016, “Nanotechnologies — Measurement technique matrix for the characterization of nano-objects.” The document provides a matrix intended to guide users to commercially available techniques relevant to the measurements of common physiochemical parameters for nano-objects. Some techniques are also applicable to nanostructured materials. As scientific advances are… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in ResearchThe International Organization for Standardization (ISO) published ISO/TR 16196:2016, “Nanotechnologies — Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials.” The goal of the standard is to assist scientists and experts to understand, plan, choose, and address issues relevant to nanomaterials before and during toxicological testing. The descriptions of sample… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe International Organization for Standardization (ISO) has published a Technical Report (TR) providing guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment. ISO states that TR 13014:2012, Nanotechnologies — Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, “is intended to assist health scientists and experts to understand, plan, identify,… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,Occupational Health and Safety Issues,OECDOn May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,Occupational Health and Safety IssuesThe International Organization for Standardization (ISO) has published a new standard, ISO/TR 13121:2011, which describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials to protect the health and safety of the public, consumers, workers, and the environment. According to ISO, the standard offers… Continue Reading
By Lynn L. Bergeson on Posted in International,Occupational Health and Safety Issues,ResearchOn January 26, 2011, the International Organization for Standardization (ISO) announced the availability of a new standard, ISO 10808:2010, entitled “Nanotechnologies — Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing.” The standard is intended to ensure that the results of inhalation toxicity tests of airborne nanoparticles are reliable and harmonized worldwide. According to ISO,… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,OECDIn a September 22, 2010, report entitled Current Developments/Activities on the Safety of Manufactured Nanomaterials, the Organization for Economic Cooperation and Development (OECD) provides information on current and planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended the seventh meeting of OECD’s Working Party on Manufactured Nanomaterials… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn July 9, 2010, the American National Standards Institute (ANSI) will host a webinar to discuss draft international guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects. The European Committee for Standardization (CEN) Technical Committee (TC) 352 Nanotechnologies and the International Organization for Standardization (ISO) TC 229 Nanotechnologies are jointly developing a Technical… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,OECDDuring the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn September 25, 2008, the International Organization for Standardization (ISO) announced the availability of ISO/TS 27687:2008, Nanotechnologies — Terminology and Definitions for Nano-Objects — Nanoparticle, Nanofibre and Nanoplate, which provides terms and definitions related to particles in the field of nanotechnologies. ISO states that it is “intended to facilitate communications between organizations and individuals in industry… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,OECDOn June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies — tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and… Continue Reading
By Lynn L. Bergeson on Posted in Federal,International,Legal/Regulatory Issues,OECD,United StatesOn December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research: On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to… Continue Reading
