Overview
ISO 10801:2010 - Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method - specifies requirements and recommendations for producing metal nanoparticle aerosols suitable for inhalation toxicity testing. The standard focuses on the evaporation/condensation method (evaporate a metal vapor, then cool to nucleate and condense nanoparticles) and is applicable to metals demonstrated to work with this technique, notably silver and gold. Annex A contains a worked example for silver; generated aerosols can provide stable particle size distributions (sizes up to ~100 nm) and continuous operation suitable for studies up to 90 days.
Key topics and technical requirements
- Generation principle: Evaporation of a metal precursor followed by controlled quench/condensation to form nanoparticles.
- System preparation and control: Parameters such as evaporation temperature, carrier flow, quench length and temperature gradients must be selected and controlled to achieve stable aerosol output.
- Nanoparticle properties: Requirements and characterization for particle size distribution, number concentration, shape, purity/impurities, stability, and suitability for inhalation studies.
- Performance characterization:
- Size distribution measurement using DMAS (differential mobility analysing system) / DEMC (differential electrical mobility classifier) and detectors such as CPC (condensation particle counter).
- Filter sampling and microscopy for mass concentration and morphology.
- Guidance on sampling frequency and interfaces to exposure chambers to avoid sampling bias and deposition loss.
- Exposure systems: Preparation and compatibility with inhalation exposure chambers (whole‑body, head/neck-only or nose-only) and monitoring to meet OECD inhalation test guidance.
- Safety and operational requirements: Capacity control, atmosphere monitoring, and system operational safety for continuous exposure testing.
- Reporting: Requirements for documenting methods, characterization data and test results.
Practical applications and users
ISO 10801:2010 is relevant to:
- Toxicologists and inhalation exposure researchers conducting animal inhalation studies (acute to subchronic).
- Aerosol scientists and laboratory engineers designing or operating evaporation/condensation nanoparticle generators.
- Occupational hygiene and safety professionals evaluating worker exposure to engineered metal nanoparticles.
- Manufacturers of nanoparticle generation systems and instrument vendors validating generator performance.
- Regulators and test laboratories implementing standardized methods for nanomaterial inhalation toxicity testing.
Related standards and references
- ISO/TS 27687 - Nanotechnologies terminology
- ISO 15900 - Differential electrical mobility analysis
- ISO/IEC 17025 - Laboratory competence
- OECD Test Guidelines: TG 403, TG 412, TG 413 for inhalation toxicity studies
Keywords: ISO 10801:2010, nanotechnologies, metal nanoparticles, evaporation/condensation method, inhalation toxicity testing, silver nanoparticles, gold nanoparticles, aerosol generation, DMAS, CPC, DEMC.