Overview
ISO/TR 19057:2017 - "Nanotechnologies - Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability" is a Technical Report from ISO/TC 229. It reviews acellular in vitro test systems and analytical methods used to evaluate the biodurability (resistance to dissolution and mechanical disintegration) of nanomaterials and their ligands in simulated biological and environmental media. The report focuses on acellular methodologies and explicitly excludes in vitro cellular or animal biodurability tests.
Key topics
- Scope and definitions: clear terminology (biodurability, dissolution, ligands, biopersistence) and normative context.
- Rationale and objectives: why biodurability matters for nanomaterial safety, environmental fate, and risk assessment.
- Simulated media: descriptions of physiological media (lung airway lining fluids, phagolysosomal fluid, saliva, gastric and intestinal fluids, simulated sweat) and environmental waters (freshwater, seawater, estuarine).
- Test systems and protocols: review of acellular dissolution approaches including static dissolution, continuous flow systems (CFS), batch/batch-filter, and tangential flow filtration.
- Analytical methods: techniques to quantify dissolved mass and characterize ligands such as UV‑Vis spectroscopy, single-particle ICP‑MS (spICP‑MS), gel permeation chromatography (GPC), MALDI‑MS, ATR‑FTIR, and LC‑MS/MS.
- Data interpretation and modelling: dissolution kinetics, dissolution rates and rate constants, halftime and lifetime estimates, and theoretical models (e.g., shrinking-sphere and shrinking-fibre concepts).
- Assessing assay validity and biological relevance: guidance on applicability, limitations, and use in risk assessment.
Practical applications
ISO/TR 19057:2017 supports practical decision-making across the lifecycle of nanomaterials:
- Designing safer nanomaterials by understanding dissolution behavior and ligand stability.
- Informing occupational and environmental risk assessments through biodurability data.
- Selecting appropriate acellular in vitro test systems and analytical workflows for regulatory dossiers or research studies.
- Interpreting dissolution kinetics for product stewardship, environmental fate modelling, and exposure assessment.
Who should use this report
- Nanomaterials researchers and laboratory scientists performing acellular dissolution testing.
- Toxicologists and risk assessors evaluating persistence and biopersistence of particulate materials.
- Product developers and materials engineers aiming to optimize coatings/ligands for controlled durability.
- Regulatory authorities and standards developers seeking harmonized approaches for biodurability data.
Related standards
ISO/TR 19057:2017 references and aligns with other ISO/IEC documents and relevant standards on terminology and testing (examples in the report include ISO/TR 13329:2012, ISO 26824:2013, ISO 17733:2015, and EN 18748:1999).