CEN/TC 352 - Nanotechnologies

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 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.

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 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 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.

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 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 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 methods of determining nanoparticle size and shape distributions by acquiring and evaluating scanning electron microscope images and by obtaining and reporting accurate results.
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.
This document applies also to SEM-based size and shape measurements of larger than nanoscale particles.

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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 specifies how to capture, measure and analyse transmission electron microscopy images to obtain particle size and shape distributions in the nanoscale.
This document broadly is applicable to nano-objects as well as to particles with sizes larger than 100 nm. The exact working range of the method depends on the required uncertainty and on the performance of the transmission electron microscope. These elements can be evaluated according to the requirements described in this document.

This document specifies the characteristics of magnetic nanosuspensions to be measured and lists measurement methods for measuring these characteristics.
This is a generic document and does not deal with any particular application.

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 a method for measuring the scratch resistance and failure behaviour for advanced materials and coatings by means of nano- and micro- scale scratch experiments. The method provides data on both the physical damage to test-pieces and the friction generated between the probe and the test-piece under single pass and multiple pass conditions. The force range in these tests is from 1 μN up to 2 N.
The test method is not applicable to coatings as defined in EN ISO 4618 [18].

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 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.

This document identifies parameters and conditions, as part of an integrated measurement system, necessary to develop and validate methods for the application of asymmetrical-flow and centrifugal field-flow fractionation to the analysis of nano-objects and their aggregates and agglomerates dispersed in aqueous media. In addition to constituent fractionation, analysis can include size, size distribution, concentration and material identification using one or more suitable detectors. General guidelines and procedures are provided for application, and minimal reporting requirements necessary to reproduce a method and to convey critical aspects are specified.

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.

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.

ISO/TR 18401:2017 is intended to assist stakeholders who are making decisions about the direction, management and application of nanotechnologies to better understand selected key terms and definitions in the ISO/IEC 80004 vocabulary series for nanotechnologies.

This document provides guidelines for all waste management activities from the manufacturing and processing of manufactured nano-objects.
The guidelines apply to all actors in the waste management chain, namely MNO manufacturers, MNO modifiers, as well as waste disposal companies and carriers and consignees of WMP-MNOs.
This document does not intend to provide guidelines on the management and disposal of nanocomposites, waste derived from consumer products containing nano-objects or waste containing only naturally occurring or incidental nano-objects. Also excluded from the scope are any waste from non-nanoscale materials resulting from the manufacturing and processing of MNOs.

This document sets requirements for sampling and treatment of the complex matrices in order to obtain a liquid dispersion with sufficiently high concentration of the nano-objects of interest.
This document provides guidelines for detection and identification of specific nano-objects in complex matrices, such as liquid environmental compartments, waste water and consumer products (e.g. food, cosmetics). This document requires for the identification a priori knowledge of the nature of the nano-objects like their chemical composition. The selected detection and identification methods are based on a combination of size classification and chemical composition analysis. Identification can also be supported, e.g. by additional morphology characterization. Currently only Field Flow Fractionation, Electron Microscopy and single particle Inductively Coupled Plasma – Mass Spectrometry fulfil this combination condition.

This document provides protocol guidelines for determining explosivity and flammability characteristics of powders containing manufactured nano-objects. These explosivity and flammability characteristics are needed for safety data sheets for safe storage, handling and transport of any powder.
In particular, this document will provide protocol guidelines concerning:
-   the determination of flammability characteristics of powders containing nano-objects with regard to sensitivity to ignition sources;
-   the ability of a powder containing nano-objects to generate an explosive atmosphere and the assessment of its explosion characteristics.
This document is not suitable for use with recognized explosives, such as gunpowder and dynamite, explosives which do not require oxygen for combustion, or substances or mixtures of substances which may under some circumstances behave in a similar manner. Where any doubt exists about the existence of hazard due to explosive properties, it is best to seek expert advice.

This document provides guidelines for application of Life Cycle Assessments (LCA) of specific relevance to manufactured nanomaterials (MNMs), including their use in other products, according to EN ISO 14044:2006. It does not cover incidental nanomaterials.

ISO/TS 80004-12:2016 lists terms and definitions relevant to quantum phenomena in nanotechnologies.
All of these terms are important for nanotechnologies, but it is to be noted that many of them are not exclusively relevant to the nanoscale and can also be used to some extent to refer to larger scales.
The list of terms presented does not claim to provide exhaustive coverage of the whole spectrum of quantum concepts and phenomena in nanotechnology. It covers important phenomena as acknowledged by many stakeholders from academia, industry, etc.
ISO/TS 80004-12:2016 is intended to facilitate communication between organizations and individuals in industry and those who interact with them.

This Technical Specification provides a guidance for the responsible development of nanotechnologies taking into account:
-   Board Accountability;
-   Stakeholder Involvement;
-   Worker Health and Safety;
-   Benefits to and Risks for Public Health, Safety and the Environment;
-   Wider Social and Ethical Implications and Impacts;
-   Engagement with Business Partners;
-   Transparency and Disclosure.
NOTE 1   This Technical Specification contributes to social responsibility as defined in ISO 26000:2010.
NOTE 2   Nanotechnology activities include industrial production, R&D, services, and marketing of products.
This Technical Specification neither covers labelling and advertising aspects nor is it intended for certification purposes, nor does it imply any legally binding agreements.
This Technical Specification intends to cover nanotechnology activities involving manufactured nanomaterials, and where relevant incidental nanomaterials.

ISO/TS 13830:2013 provides guidance on the content of voluntary labels for consumer products containing manufactured nano-objects.

ISO/TR 11811:2012 establishes techniques for the evaluation of tribological performance of sliding contacts with a lateral size of between a few nanometres and 10 µm, and where the applied load is between 50 µN and 100 mN. It describes procedures for undertaking these measurements, and provides guidance on the effect of parameters on test results. It does not cover existing SPM techniques, such as frictional force microscopy and atomic force microscopy (AFM).

ISO 10808:2010 specifies requirements for, and gives guidance on, the characterization of airborne nanoparticles in inhalation exposure chambers for the purpose of inhalation toxicity studies in terms of particle mass, size distribution, number concentration and composition.

ISO 10801:2010 gives requirements and recommendations for generating metal nanoparticles as aerosols suitable for inhalation toxicity testing by the evaporation/condensation method. Its application is limited to metals such as gold and silver which have been proven to generate nanoparticles suitable for inhalation toxicity testing using the technique specified.

ISO 29701:2010 describes the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems. The test is suitable for use with nanomaterial samples dispersed in aqueous media, e.g. water, serum or reaction medium, and to such media incubated with nanomaterials for an appropriate duration at 37 °C.
ISO 29701:2010 is restricted to test samples for in vitro systems, but the methods can also be adapted to nanomaterials to be administered to animals by parenteral routes.

ISO/TS 80004-13:2017 lists terms and definitions for graphene and related two-dimensional (2D) materials, and includes related terms naming production methods, properties and their characterization.
It is intended to facilitate communication between organizations and individuals in research, industry and other interested parties and those who interact with them.

ISO/TS 19590:2017 specifies a method for the detection of nanoparticles in aqueous suspensions and characterization of the particle number and particle mass concentration and the number-based size distribution using ICP-MS in a time-resolved mode to determine the mass of individual nanoparticles and ionic concentrations.
The method is applicable for the determination of the size of inorganic nanoparticles (e.g. metal and metal oxides like Au, Ag, TiO2, BVO4, etc.), with size ranges of 10 nm to 100 nm (and larger particles up to 1 000 nm to 2 000 nm) in aqueous suspensions. Metal compounds other than oxides (e.g. sulfides, etc.), metal composites or coated particles with a metal core can be determined if the chemical composition and density are known. Particle number concentrations that can be determined in aqueous suspensions range from 106 particles/L to 109 particles/L which corresponds to mass concentrations in the range of approximately 1 ng/L to 1 000 ng/L (for 60 nm Au particles). Actual numbers depend on the type of mass spectrometer used and the type of nanoparticle analysed.
In addition to the particle concentrations, ionic concentrations in the suspension can also be determined. Limits of detection are comparable with standard ICP-MS measurements. Note that nanoparticles with sizes smaller than the particle size detection limit of the spICP-MS method may be quantified as ionic.
The method proposed in this document is not applicable for the detection and characterization of organic or carbon-based nanoparticles like encapsulates, fullerenes and carbon nanotubes (CNT). In addition, it is not applicable for elements other than carbon and that are difficult to determine with ICP-MS. Reference [5] gives an overview of elements that can be detected and the minimum particle sizes that can be determined with spICP-MS.

ISO/TS 80004-11:2017 lists terms and definitions, and specifies an extensible taxonomic terminology framework for nanolayers, nanocoatings, nanofilms, and related terms in the field of nanotechnologies.

ISO/TS 80004-2:2015 lists terms and definitions related to particles in the field of nanotechnologies.

ISO/TS 80004-1:2015 lists terms and definitions related to core terms in the field of nanotechnologies. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.

ISO/TS 80004-4:2011 gives terms and definitions for materials in the field of nanotechnologies where one or more components are nanoscale regions and the materials exhibit properties attributable to the presence of those nanoscale regions. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.
Materials classified as nanostructured have an internal or surface structure with a significant fraction of features, grains, voids or precipitates in the nanoscale. Articles that contain nano-objects or nanostructured materials are not necessarily nanostructured materials themselves.
ISO/TS 80004-4:2011 includes nanodispersion.

This Technical Specification provides guidelines 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 guidance for relevant and reliable measurement.

ISO/TS 12025:2012 provides methodology 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. In addition to information in terms of mass, the aerosol is characterized for particle concentrations and size distributions.
ISO/TS 12025:2012 provides information on factors to be considered when selecting from 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 recommended in ISO/TS 12025:2012.

ISO/TS 80004-6:2013 lists terms and definitions relevant to the characterization of nano-objects.

ISO/TS 80004-8:2013 gives terms and definitions related to nanomanufacturing processes in the field of nanotechnologies. It forms one part of multi-part terminology and definitions documentation covering the different aspects of nanotechnologies.

ISO/TS 80004-3:2010 lists terms and definitions related to carbon nano-objects in the field of nanotechnologies. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.

ISO/TS 17200:2013 lists fundamental characteristics which are commonly determined for nanoparticles in powder form. ISO/TS 17200:2013 prescribes specific measurement methods for each of these characteristics.

ISO/TS 27687:2008 lists unambiguous terms and definitions related to particles in the field of nanotechnologies. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.

This part of ISO/TS 80004 lists terms and definitions related to core terms in the field of nanotechnologies. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.

This Technical Specification lists terms and definitions related to particles in the field of nanotechnologies. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.