Overview
EN ISO 10801:2010 (ISO 10801:2010) defines requirements and recommendations for generating metal nanoparticles as aerosols for inhalation toxicity testing using the evaporation/condensation method. The standard is intended for metals proven suitable with this technique (notably silver and gold). It describes generator performance, characterization, and reporting to support reproducible, controlled exposures for short- and long-term toxicity studies.
Key topics and technical requirements
- Generation principle: evaporation of bulk metal followed by condensation to form aerosolized nanoparticles (example method for silver is given in Annex A).
- Applicable materials: limited to metals with appropriate melting/evaporation behavior (e.g., silver, gold).
- Particle properties: requirements and guidance on size range (particle sizes up to 100 nm are covered), number concentration, shape, purity/impurities, and stability for continuous studies (method shown to provide stability suitable for up to 90 days).
- Characterization methods: use of differential mobility analysing systems (DMAS) and differential electrical mobility classifiers (DEMC) for particle size distribution; condensation particle counters (CPC) and filter sampling for number and mass concentration.
- System requirements: capacity and control, exposure chamber atmosphere specifications (whole‑body, head‑only, nose‑only), and system operational safety.
- Quality & reporting: requirements for documenting generator performance, sampling frequency, measurement methods, and a standardized test report to ensure reproducibility and regulatory acceptance.
Practical applications and users
- Who uses it: toxicologists, occupational and environmental health researchers, inhalation exposure laboratories, nanomaterial manufacturers, regulatory testing facilities, and contract research organizations (CROs).
- Where it applies: designing and conducting inhalation toxicity studies (acute, subacute, subchronic), validating nanoparticle generation systems, comparing exposure methods, and supporting regulatory submissions. The generated aerosols are suitable for animal exposure studies (whole‑body, head‑only, nose‑only) and for advanced in‑vitro methods (e.g., labs‑on‑a‑chip).
- Practical value: promotes reproducible aerosol generation and standardized measurement procedures, enabling comparable toxicology data across labs and supporting occupational risk assessment for engineered metal nanoparticles.
Related standards
- ISO/TS 27687 - Nanotechnologies: terminology for nano‑objects
- ISO 15900 - Differential electrical mobility analysis (DMAS/DEMC)
- ISO/IEC 17025 - Laboratory competence
- OECD TG 403, 412, 413 - Inhalation toxicity test guidelines (acute to 90‑day studies)
Keywords: EN ISO 10801:2010, ISO 10801:2010, nanotechnologies, metal nanoparticles, inhalation toxicity testing, evaporation/condensation method, silver nanoparticles, gold nanoparticles, aerosol generation, DMAS, DEMC, CPC.