ISO/TC 229 - Nanotechnologies

This document specifies methods for characterizing the chemical properties of powders or liquid dispersions containing graphene-related two-dimensional material (GR2M), using a set of suitable measurement techniques. This document covers the determination of elemental composition, oxygen to carbon ratio, trace metal impurities, weight percentage of chemical species and functional groups present, by use of the following techniques: — X-ray photoelectron spectroscopy (XPS); — thermogravimetric analysis (TGA); — inductively coupled plasma mass spectrometry (ICP-MS); —Fourier-transform infrared spectroscopy (FTIR). This document covers sample preparation, protocols and data analysis for the different techniques.

This document specifies the characteristics and their respective measurement methods of graphene-related 2D materials in sheet and particle forms for commercial applications with the aim of classification of the materials. The classification framework consists of the following elements: a) relevant material characteristics for commercial use; b) identification of applicable measurement methods; c) a range of the characteristic measured values when applicable; d) syntax to guide consistent naming and descriptions; e) an applicable technical data sheet template.

This document specifies a method to quantify and identify air concentration (number of particles/cm3) of particles of either carbon black or amorphous silica, or both, by size in air samples collected in a mixed dust, industrial, manufacturing environment. This method is applicable to air samples collected with an electrical low pressure cascade impactor (ELPCI) for sampling in manufacturing environments where there are a variety of particle types contributing to the overall atmosphere. This method is applicable only to environments with chemically and physically distinct particles contributing to aerosols or where confounders can be controlled (e.g. diesel sources).

This document specifies a procedure to evaluate acute phototoxicity of nanoparticles (NPs), suspended in cell culture media, by measuring the relative reduction in cellular viability under near ultraviolet (UVA) exposure (315 nm to 400 nm). The measurement is intended to assess the potential for acute phototoxicity of NPs by comparing NP photoactivity in vitro to a positive control chlorpromazine. It is not designed to predict other joint effects of nanomaterials and light, such as genotoxicity, photo-allergy or photo-mutagenicity. The method is also applicable to NP aggregates and agglomerates.

This document specifies the determination of the bulk crystallinity (crystalline contribution relative to the total crystalline and amorphous contributions in the material) of cellulose nanomaterials using powder X-ray diffraction followed by deconvolution of the diffraction patterns based on Rietveld analysis. It is applicable to all types of cellulose nanomaterials, assuming a representative sample.

This document provides guidance on the development of content for, and consistency in, the communication of information on safety, health and environmental matters in safety data sheets (SDS) for substances classified as manufactured nanomaterials (and materials or products that contain manufactured nanomaterials). It provides additional information on safety issues associated with manufactured nanomaterials. It provides supplemental guidance to ISO 11014 on the preparation of SDSs.

This document defines terms for graphene, graphene-related two-dimensional (2D) materials and other 2D materials. It includes related terms for production methods, properties and characterization. It is intended to facilitate communication between organizations and individuals in research, industry and other interested parties and those who interact with them.

This document provides guidance on occupational health and safety measures relating to materials that contain and release engineered or manufactured NOAA during their life cycle, including the use of engineering controls and appropriate personal protective equipment, guidance on dealing with spills and accidental releases and guidance on appropriate handling of these materials during disposal. This document is intended to be used by competent personnel, such as health and safety managers, production managers, environmental managers, industrial/occupational hygienists and others with responsibility for the safe operation of facilities engaged in production, handling, processing and disposal of these materials.

This document specifies parameters, conditions and considerations for the reliable detection, characterization and quantification of nano-objects in aqueous suspension by spICP-MS. Particle number concentration, particle mass, particle mass concentration, particle spherical equivalent diameter, and number-based size distribution are considered the main measurands, but the technique also allows for determination of the dissolved element mass fraction in the sample. This document provides general guidelines and procedures related to spICP-MS application, and specifies minimal reporting requirements.

This document describes a method for performing positron annihilation lifetime measurements using a 22Na positron source that decays with β+ emission. The β+ (positron) lifetime is determined from a measurement of the lifetime of the ortho-positronium which ranges from 1 ns to 10 ns (ascribed to a pore size from approximately 0,3 nm to 1,3 nm in diameter), as observed for polymeric materials in which the positronium atoms mostly annihilate via a two-gamma annihilation process. This document is not applicable to thin surface layers (that are less than several micrometers). This document does not apply to measuring: — non-positronium forming materials; — positronium-forming materials that induce a spin conversion reaction; — positronium-forming materials that contain chemicals influencing the annihilation process of ortho-positronium by chemical reactions; — positronium-forming materials that contain mesoporous silica gels with a large contribution from the three-gamma annihilation process.

This document provides: a) a review of radioisotope labelling methods that can be used for nanomaterials; b) the advantages and disadvantages of each radioisotope labelling method; c) information on the selection of a matched pair of nanomaterial and radioisotope labelling method to ensure the in vivo integrity of radioisotope-labelled nanomaterials or the stability of their performance.

This document specifies the characteristics of samples of silica with ordered nanopore array (SONA) to be measured in powder form and the industrially available measurement methods used to determine said characteristics. This document provides a sound base for the research, development and commercialization of SONA for various applications. This document excludes silica-gel, fumed silica and chemically modified SONA. NOTE The pore size of SONA ranges usually from one nanometre to several tens of nanometres.

This document defines terms related to liposomes in nanotechnologies, within the context of biological systems and biomedical applications. In this context, liposomes are one form of lipid-based nanomaterials. This document does not address terms that can be relevant to other types of lipid-based particles (e.g. solid lipid nanoparticles).

This document provides an extraction method using the proteinase K (PK) for nanomaterials deposited in the lung. This document specifies the advantages of the PK digestion method and examples of nanomaterials to which it can be applied. This document focuses on extracting nanomaterials from lung tissue and separating nanoparticles from their ionic counterparts. This method is potentially (or theoretically) applicable to any particles that are insoluble during the PK digestion process.

This document provides an overview of the methods used to determine the nanoparticle number concentration in liquid dispersions and aerosols. The methods described are the ensemble measurement techniques of differential centrifugal sedimentation (DCS), multi-angle dynamic light scattering (MDLS), small-angle X-ray scattering (SAXS) and ultraviolet-visible spectroscopy (UV-vis) and the particle counting methods of particle tracking analysis (PTA), resistive pulse sensing (RPS), single particle inductively coupled plasma mass spectrometry (spICP-MS), condensation particle counter (CPC), and differential mobility analysing system (DMAS). This document provides information on the use of each technique, along with considerations on sample preparation, advantages and limitations.

The document provides information on the measurement of nanomaterial mass in tissue after inhalation exposure, which can inform on lung clearance behaviour and translocation.

This document specifies requirements and recommendations for performance assessment methods for superhydrophobic surfaces and coatings subjected to mechanical stress, solar radiation and weathering, liquids, and thermal cycling, where applicable, based on the agreement between interested parties. The performance assessment is carried out based on comparative measurements of the advancing and receding angles and the calculation of the contact angle hysteresis before and after the above-mentioned working/environmental conditions. This document does not address safety and environmental related issues of such coatings. This document is applicable to any superhydrophobic surfaces and coatings (i.e. nanostructured) on which the measurement of the advancing and receding angles is possible.

This document specifies the characteristics and performance(s) of the superhydrophobic textiles containing nanomaterials and nanostructures (TCNNs) based on contact angle measurement before and after being subjected to washing/drying (laundry), ironing processes, light sources and abrasion, that are to be determined by agreement between customer and supplier. This document solely covers woven and nonwoven fabrics. This document does not address safety and health related issues.

This document specifies a mild oxidation method to determine the content of carbon impurities (carbon material content not in the form of CNT, including amorphous carbon and trace amountd of other types of structured carbon) less stable than multiwall carbon nanotubes (MWCNTs) by thermogravimetric analysis (TGA) under carbon dioxide atmosphere. This document is applicable to the characterization of carbon impurities content in MWCNT samples prepared by chemical vapour deposition (CVD). Measurement of carbon impurities in MWCNT samples prepared by other methods can refer to this document. This method is not applicable to functionalized MWCNT samples or MWCNT samples with encapsulant species. NOTE This method is applicable for the case of TG curves with a single-stage.

This document defines core terms in the field of nanotechnology. This document is intended to facilitate communication between organizations and individuals in industry and those who interact with them.

This document specifies the performance evaluation of nanosuspensions containing clay nanoplates for quorum quenching in crop production. This document does not cover safety and environmental aspects.

This document describes the characteristics of working suspensions of nano-objects to be considered when conducting in vitro assays to evaluate inherent nano-object toxicity. In addition, the document identifies applicable measurement methods for these characteristics. This document is applicable to nano-objects, and their aggregates and agglomerates greater than 100 nm. This document intends to help clarify whether observed toxic effects come from tested nano-objects themselves or from uncontrolled sources.

This document defines terms and definitions for different types of cellulose nanomaterials including secondary components found in cellulose nanomaterials originating from their manufacturing processes. This document also provides information on cellulose micromaterials in Annex B. Where necessary, terms from the ISO/IEC 80004 series are included in this document. Terms in this document are applicable to all types of cellulose nanomaterials, regardless of production methods and their origin (plants, animals, algae or bacteria).

This document describes minimum requirements for performance evaluation of applying fluorescent nanoparticles in quantitative immuno-histochemistry.

This document specifies a method for assessing the peroxidase-like activity of metal and metal oxide nanoparticles by spectrophotometry. This document can serve as a reference for the measurements of peroxidase-like activities in other types of nanoparticles.

This document describes the performance characteristics necessary to evaluate the detection performance of nanosensors for chemical and biomolecule detection. This document does not cover the analytical performance characteristics or the performance evaluation procedure of a specific sensor.

This document provides a reliable and repeatable method for simultaneous assessment of both exposure and toxicity of manufactured nano-objects (MNOs) using Tetrahymena sp. The ingested, internalized material (MNOs) indicates aquatic exposure. This document is intended to be used by all the centers working with nano(eco)toxicity of MNOs and capable of culturing of Tetrahymena sp. The method uses Tetrahymena sp. to assess exposure and effects of MNOs. In addition, the test can be used by centers (laboratories) interested in investigating the biological interaction of MNOs with living cells. This method is applicable to nano-objects such as nanoparticles, nanofibres of certain size (in a µm size range), nanoplates, as well as their aggregates and agglomerates.

This document reviews characterization of CNT and CNF aerosols for inhalation exposure studies. The document also provides useful information on appropriate characterization of CNT and CNF, which is required to evaluate and understand the inhalation toxicity of CNT and CNF aerosols. This document neither provides guidance on aerosol characterization for other carbon nanomaterials, nor provides guidance for characterization of carbon nanotube and nanofibre aerosols in the workplace or ambient air.

This document provides guidance and requirements for the determination of the mean (spherical) equivalent diameter of nano-objects (i.e. particles, droplets or bubbles) dispersed in liquids using the static multiple light scattering (SMLS) technique. The technique is applicable to a wide range of materials and does not require dilution of concentrated samples.

This document specifies requirements and recommendations for the identification of measurands to characterize nano-objects and their agglomerates and aggregates, and to assess specific properties relevant to the performance of materials that contain them. It provides recommendations for relevant measurement.

This document describes a method for high throughput evaluation of cytotoxic response of 3D model cells exposed to NPs without optical interference. The method in this document is intended to be used in biological testing laboratories that are competent in the culture and growth of cells and the evaluation of cytotoxicity of NPs using 3D-model cells. This method applies to materials that consist of nano-objects such as nanoparticles, nanopowders, nanofibres, nanotubes, and nanowires, as well as aggregates and agglomerates of these materials.

This document specifies characteristics to be measured of magnetic beads in suspension and powder forms for nucleic acid extraction applications. This document deals with magnetic beads that contain a substantial amount of magnetic nanoparticles (which can be superparamagnetic). Potential applicable measurement methods are listed for the individual characteristics. Specifically, this document lists critical characteristics of magnetic beads and suspensions, and additional characteristics to describe the magnetic beads and the suspension for nucleic acid extraction. Health, safety and environmental aspects of magnetic beads are not within the scope of this document.

This document specifies the antimicrobial performance assessment method of textiles containing manufactured (metals/metal oxides) nanomaterials (TCMNMs). The textiles in this document include fabric, yarn and fibre in which manufactured nanomaterials are used during production or finishing process. Further, this document also specifies protocols to determine the quantity of nanomaterials released from textile following washing and/or exposure to artificial human body sweat. This document only covers the antibacterial, antifungal, and the anti-odour performance assessment method of TCMNMs. This document does not cover textiles that have therapeutic application as well as environment, health and safety (EHS) issues related to TCMNMs. Further, it does not cover the release of nanomaterials from TCMNMs as a result of aging, dry attrition and abrasion, although it is considered as an effective factor in releasing nanomaterials.

This document describes methods for the measurement of particle size distributions for cellulose nanocrystals using atomic force microscopy and transmission electron microscopy. The document provides a protocol for the reproducible dispersion of the material using ultrasonication, as assessed using dynamic light scattering. Sample preparation for microscopy, image acquisition and data analysis are included.

This document describes a near-infrared optical absorption method to estimate the in vitro cellular uptake of carbon nanomaterials including both internalized and/or tightly adhered to the cell membrane from liquid dispersions. This is a simple method to screen carbon nanomaterials uptake; additional analysis using a different technique can be required if quantification is desired.

This document describes a methodology of a label free and real-time detection for non-invasive monitoring of cell-based assays to assess toxicity of nanomaterials to eukaryotic and prokaryotic cells.

This document reviews and evaluates the utility of available methods to assess material released from commercial polymer composites in support of product use and safety decisions, and describes what revised or additional methods are needed. The document is not focused on describing methods per se; rather the goal is to describe information that is appropriate for consideration in the selection of methods to support decision-making.

This document specifies methods of determining nanoparticle size and shape distributions by acquiring and evaluating scanning electron microscope images and by obtaining and reporting accurate results. NOTE 1 This document applies to particles with a lower size limit that depends on the required uncertainty and on the suitable performance of the SEM, which is to be proven first -according to the requirements described in this document. NOTE 2 This document applies also to SEM-based size and shape measurements of larger than nanoscale particles.

This document provides guidance for sample preparation, data acquisition by transmission electron microscopy, data processing, and three-dimensional image reconstruction to measure size and shape parameters of nano-objects on rod-shaped supports. The method is applicable to samples dispersed on or within an electron-transparent rod-shaped support.

This document describes methods for the quantification of nano-object release from powders as a result of treatment, ranging from handling to high energy dispersion, by measuring aerosols liberated after a defined aerosolization procedure. Particle number concentration and size distribution of the aerosol are measured and the mass concentration is derived. This document provides information on factors to be considered when selecting among the available methods for powder sampling and treatment procedures and specifies minimum requirements for test sample preparation, test protocol development, measuring particle release and reporting data. In order to characterize the full size range of particles generated, the measurement of nano-objects as well as agglomerates and aggregates is adressed in this document. This document does not include the characterization of particle sizes within the powder. Tribological methods are excluded where direct mechanical friction is applied to grind or abrade the material.

This document specifies characteristics to be measured and measurement methods for clay nanoplate samples in powder and suspension forms used for gas-barrier films. In addition, measurement protocols for the individual characteristics are described. This document does not deal with characteristics of post-manufacturing modification of clay nanoplates. This document does not cover considerations specific to health and safety issues either during manufacturing or use.

This document defines terms related to the characterization of nano-objects in the field of nanotechnologies. It is intended to facilitate communication between organizations and individuals in research, industry and other interested parties and those who interact with them.

IEC TR 63258:2021 is a Technical Report focused on the practical protocol of ellipsometry to evaluate the thickness of nanoscale films. This document does not include any specification of the ellipsometers, but suggests how to minimize the data variation to improve data reproducibility.

This document specifies characteristics to be measured of individualized cellulose nanofibril (iCNF) samples in suspension and powder forms and their measurement methods. In addition, it provides sample preparation, measurement and data analysis procedures. This document does not apply to the characterization of iCNFs that have been modified after they are manufactured.

This document specifies the sequence of methods for characterizing the structural properties of graphene, bilayer graphene and graphene nanoplatelets from powders and liquid dispersions using a range of measurement techniques typically after the isolation of individual flakes on a substrate. The properties covered are the number of layers/thickness, the lateral flake size, the level of disorder, layer alignment and the specific surface area. Suggested measurement protocols, sample preparation routines and data analysis for the characterization of graphene from powders and dispersions are given.

This document specifies measurement protocols and test conditions to determine alterations to protein secondary structure induced by their interaction with nanomaterials using ultraviolet circular dichroism (UV-CD) spectroscopy. This document does not apply to the characterization of conformational changes of disordered proteins.

This document specifies characteristics to be measured of nanostructured porous alumina in powder form as catalyst support for vehicle exhaust emission control and their relevant measurement methods. It includes critical characteristics that are required to be measured and additional characteristics that are recommended to be measured, based upon agreement between the interested parties. Measurement methods for each characteristic are recommended. This document is applicable to nanostructured porous alumina for gasoline-powered cars. It does not apply to characteristics specific for health, the environment and safety issues.

This document defines terms related to nanomanufacturing processes in the field of nanotechnologies. All the process terms in this document are relevant to nanomanufacturing, however, many of the listed processes are not exclusively relevant to the nanoscale. Terms that are not exclusive are noted within the definitions. Depending on controllable conditions, such processes can result in material features at the nanoscale or, alternatively, at larger scales. There are many other terms that name tools, components, materials, systems control methods or metrology methods associated with nanomanufacturing that are beyond the scope of this document. Terms and definitions from other parts of the ISO/TS 80004 series are reproduced in Clause 3 for context and better understanding.

This document defines terms related to carbon nano-objects in the field of nanotechnologies. It is intended to facilitate communication between organizations' and individuals' research, industry and other interested parties and those who interact with them. Additional terms and definitions for graphene and two-dimensional materials (2D) materials are provided in ISO/TS 80004-13. Related carbon nanoscale materials are given in Annex A.

This document specifies the fundamental characteristics to be measured of a sample of engineered nanoparticles in powder form to determine the size, the chemical content and the surface area. This document also specifies measurement methods for determining each of the characteristics. It is intended to facilitate communication among consumers, regulators and industries with the necessary characteristics. It excludes characteristics that pertain to specific industrial applications of nanoparticles in powder form and detailed measurement protocols, as well as characteristics related to health, safety and environmental issues.