Overview
EN ISO 10808:2010 (ISO 10808:2010) - Nanotechnologies - provides requirements and guidance for the characterization of airborne nanoparticles in inhalation exposure chambers used in inhalation toxicity testing. The standard focuses on monitoring and reporting particle mass, particle size distribution, particle number concentration and composition to support reliable inhalation toxicology studies and exposure assessment for nanomaterials.
Key topics and requirements
- Scope and purpose
- Specifies how to characterize nanoparticles in inhalation exposure chambers (nose-only, whole-body) for toxicity testing.
- Particle measurement systems
- Recommends use of systems such as Differential Mobility Analyzers (DEMC/DEMS), Condensation Particle Counters (CPC) and integrated DMAS for number‑based size distribution and concentration measurement.
- Advises morphological and compositional analysis using TEM/SEM with EDXA.
- Measured parameters
- Number concentration, number-based size distribution (e.g., CMD, GMD, GSD), mass concentration, surface area (where relevant) and chemical composition.
- Monitoring locations
- Emphasizes sampling from the animal’s breathing zone to ensure representative exposure data.
- Data assessment and reporting
- Defines how to calculate and report geometric mean diameter (GMD), geometric standard deviation (GSD) and other distribution statistics.
- Includes requirements for test reports to document chamber performance and nanoparticle characterization.
- References and harmonization
- Normative references include ISO 15900, ISO/TS 27687 and relevant OECD inhalation test guidelines (TG 403, 412, 413).
Applications and users
Who uses EN ISO 10808:2010:
- Inhalation toxicologists and academic researchers conducting nano‑inhalation studies.
- Contract research organizations (CROs) and laboratories running animal inhalation exposure chambers.
- Regulatory bodies and safety assessors evaluating inhalation risk of nanomaterials.
- Occupational hygienists and industrial R&D teams designing exposure controls and risk mitigation.
- Instrument manufacturers and QA personnel validating chamber monitoring systems.
Practical uses:
- Designing and validating inhalation exposure studies for nanoparticles (e.g., TiO2, silica, carbon-based).
- Generating standardized exposure metrics for regulatory submissions, risk assessments and reproducible research.
- Ensuring representative sampling (breathing zone) and multi-parameter characterization (number, size, mass, composition).
Related standards
- ISO 15900 - Differential electrical mobility analysis for aerosol particles
- ISO/TS 27687 - Nanotechnologies terminology and definitions
- OECD TG 403, 412, 413 and GD 39 - Inhalation toxicity guidance
Keywords: EN ISO 10808:2010, ISO 10808:2010, nanotechnologies, nanoparticles, inhalation exposure chambers, inhalation toxicity testing, DMAS, particle size distribution, number concentration, TEM, SEM.