Overview
ISO/TS 16195:2018 - Nanotechnologies: Specification for developing representative test materials consisting of nano-objects in dry powder form - defines how to produce and document representative test materials (RTMs) of nano-objects in dry powder form. The technical specification helps laboratories, manufacturers and standards bodies create powders that support test method development, improve data comparability, and enable reliable inter‑laboratory evaluations when certified reference materials are unavailable.
Key topics and technical requirements
ISO/TS 16195:2018 focuses on physico‑chemical characterization, quality management and reporting. Major requirements include:
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Size and shape
- Measure size distribution of primary particles and aggregates using particle-counting imaging methods (e.g., TEM, SEM, AFM).
- Report representative sizes (mean, percentiles) and clearly state whether distributions refer to primary particles or aggregates.
- Provide representative micrographs with scale bars and sample/preparation details.
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Specific surface area
- Determine surface area (for example by BET gas adsorption) and report the method and results.
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Bulk chemical composition
- Quantify elemental or chemical composition using appropriate methods (e.g., XRF, ICP‑MS, AAS, titrimetry) with metrological traceability where applicable.
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Crystal structure
- Identify crystalline phases (e.g., by X‑ray diffraction) or report amorphous character.
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Stability and homogeneity
- Assess stability and homogeneity (e.g., per ISO Guide 35) including effects of temperature, humidity, vibration and radiation; recommend storage/packaging.
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Documentation and verification report
- Include manufacturing process description, quality management information, measurement data, and stability/homogeneity evidence in a verification report suitable for test method development.
Applications and users
ISO/TS 16195:2018 is practical for:
- Test laboratories and inter‑laboratory studies developing or validating nanoparticle measurement methods.
- Producers of nanomaterials who need standardized RTMs to demonstrate material consistency.
- Standards developers and accreditation bodies using RTMs to improve method comparability.
- Regulatory agencies and researchers requiring robust material characterization for safety, toxicology and performance testing.
Using RTMs developed to ISO/TS 16195 improves reproducibility of measurements across labs and supports method development where certified reference materials are not yet available.
Related standards
Commonly used alongside:
- ISO Guide 31, ISO Guide 35 (reference materials guidance)
- ISO/TS 80004‑1/2/3 (nanotechnology vocabulary)
- ISO 9276‑1/2/3/6, ISO 13322‑1 (particle sizing and image analysis)
- ISO 9277 (BET specific surface area)
Keywords: ISO/TS 16195:2018, nanotechnologies, representative test material, nano-objects, dry powder, physico-chemical characterization, size distribution, specific surface area, crystal structure, stability, metrological traceability.