ISO TR 13014-2012 PDF

Full title and description

ISO/TR 13014:2012 — Nanotechnologies — Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment. This technical report provides informative guidance to toxicologists, health & safety professionals, regulators and laboratory staff on which physico‑chemical properties of manufactured nano‑objects and their aggregates/agglomerates should be identified and measured to support reproducible and interpretable toxicological testing of nanomaterials.

Abstract

ISO/TR 13014:2012 explains terminology, measurement concepts and the core physico‑chemical parameters that influence toxicological behaviour of manufactured nano‑objects. For each selected property the report describes relevance to toxicology, the measurand, examples of measurement methods and considerations on measurement expression, traceability and uncertainty. The report is informative (a Technical Report) rather than a set of normative test methods.

General information

• Status: Published.
• Publication date: May 2012 (published 2012‑05; commonly referenced as 7–8 May 2012).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.120 – Nanotechnologies (also associated with physical/chemical measurement categories).
• Edition / version: Edition 1 (2012).
• Number of pages: 33 pages (Technical Report).

Key bibliographic and lifecycle metadata above are taken from ISO’s catalogue entry for the technical report.

Scope

This Technical Report gives guidance for physico‑chemical characterization of manufactured nano‑objects and their aggregates/agglomerates (NOAA) presented for toxicological testing. Its purpose is to help ensure that the material under test is well‑described so toxicological results can be interpreted, compared and reproduced — e.g., by describing which properties should be measured, when characterization is needed and how results should be reported for toxicology studies.

Key topics and requirements

• Terminology and definitions relevant to nano‑objects, nanoparticles, nanofibres, aggregates and agglomerates.
• Guidance on when physico‑chemical characterization is necessary for toxicological studies.
• Core characterization parameters: particle size and size distribution; aggregation/agglomeration state in relevant media; particle shape and morphology; surface area (mass‑ and volume‑specific); chemical composition and crystallinity; surface chemistry and surface charge; solubility and dispersibility.
• Examples of measurement methods for each parameter and guidance on measurands.
• Recommendations on reporting, metrological traceability, measurement uncertainty and validation considerations to support interpretation of toxicology data.

The list above summarizes the principal topics addressed in the report and reflects its role as informative guidance rather than prescriptive test methods.

Typical use and users

Primary users are toxicologists, ecotoxicologists, laboratory managers, test method developers, regulators, risk assessors and occupational health professionals who need to design, interpret or evaluate toxicological testing of manufactured nanomaterials. The report is used to plan which physico‑chemical measurements to perform and how to report material characteristics in toxicology studies so results are comparable and reproducible across laboratories.

Related standards

ISO/TR 13014:2012 was developed by ISO/TC 229 (Nanotechnologies) and is related to a number of other ISO documents on nanomaterial vocabulary, characterization and safety (for example ISO/TS 80004 series for vocabulary, ISO/TS documents on measurement and reporting, and other ISO/TC 229 technical reports and specifications covering risk evaluation, SDS preparation and measurement techniques). The ISO/TC 229 catalogue lists related deliverables and updates in the nanotechnology standards portfolio.

Keywords

nanotechnologies; nano‑objects; nanoparticles; physico‑chemical characterization; toxicologic assessment; particle size; surface chemistry; aggregation; measurement uncertainty; ISO/TC 229.

FAQ

Q: What is this standard?

A: ISO/TR 13014:2012 is an ISO Technical Report that provides guidance (informative, not normative) on which physico‑chemical properties of manufactured nano‑objects should be characterized and reported to support toxicological testing and interpretation.

Q: What does it cover?

A: It covers terminology, when to perform characterization for toxicology, core parameters (size/distribution, aggregation state, shape, surface area, composition/crystallinity, surface chemistry/charge, solubility/dispersibility), example measurement methods and guidance on reporting, traceability and measurement uncertainty.

Q: Who typically uses it?

A: Toxicologists, ecotoxicologists, laboratory personnel, regulators, risk assessors and others involved in designing or interpreting toxicological studies of engineered nanomaterials use this report to ensure materials are characterised and described consistently.

Q: Is it current or superseded?

A: The document is published as ISO/TR 13014:2012 (Edition 1). Users should check the ISO catalogue or their national standards body for any amendments or later related publications; a corrigendum was issued in 2012 to correct the published text. For the most current normative requirements or new measurement‑method standards, check subsequent ISO/TC 229 outputs.

Q: Is it part of a series?

A: It is part of the ISO/TC 229 nanotechnologies work program and sits alongside other ISO technical reports and technical specifications addressing nanomaterial vocabulary, characterization methods and safety/risk guidance (for example ISO/TS and ISO/TR documents in the 13000–13999 range and the ISO/TS 80004 vocabulary series).

Q: What are the key keywords?

A: Nanotechnologies, nano‑objects, nanoparticles, physico‑chemical characterization, toxicology, particle size, surface chemistry, aggregation, measurement uncertainty, ISO/TC 229.