Overview
ISO/TR 18637:2016 - Nanotechnologies: Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs) - is a Technical Report from ISO/TC 229 that summarizes state-of-the-art methods for deriving occupational exposure limits (OELs) and occupational exposure bands (OEBs) for manufactured nano-objects, aggregates and agglomerates (NOAAs). The document presents an evidence-based framework to support occupational health risk management, hazard communication and control-band decision-making where nano-specific toxicity and exposure data are limited.
Key topics
- Frameworks for OEL/OEB development: description of general processes, evidence-based approaches, and feasibility considerations for setting exposure limits and bands for NOAAs.
- Substance-specific OELs: overview and evaluation of existing OELs for selected nanomaterials (e.g., carbon nanotubes, TiO2, fullerenes) and discussion of data and methodological differences.
- Categorical OELs and read-across: approaches that derive limits for groups of nanomaterials based on physico‑chemical properties and biological mode-of-action.
- Initial/default OEBs and control banding: methods to assign hazard bands/OEBs when specific toxicity data are lacking and integration with control-banding tools.
- Hazard and exposure assessment challenges: practical issues in sampling and measurement (distinguishing background nanoparticles, measurement of CNTs/CNFs, mass vs. particle metrics) and uncertainty in current methods.
- Case studies and evaluation: comparisons of national and organizational approaches (e.g., NIOSH, OECD, national frameworks) and critical analysis of methodological impacts on derived OELs.
Applications
ISO/TR 18637:2016 is intended to:
- Support development and validation of OELs and OEBs for engineered nanomaterials used in industry.
- Inform occupational health risk assessments, exposure monitoring strategies and selection of engineering controls.
- Guide hazard communication and implementation of control-banding approaches where detailed toxicology is unavailable.
- Help harmonize methodological approaches to improve consistency in worker protection across jurisdictions.
Who should use this standard
- Occupational safety and health professionals in government, industry and academia
- Industrial hygienists and risk assessors developing exposure limits or banding schemes
- Regulators and standards developers seeking harmonized methods
- Small- and medium-sized enterprises using control-banding tools to manage nano‑material risks
Related standards
- ISO/TS 12901-2 (control banding for nanomaterials)
- NIOSH Current Intelligence Bulletin approaches and OECD reports on categorization of manufactured nanomaterials
Keywords: ISO/TR 18637:2016, nanotechnologies, occupational exposure limits, OEL, occupational exposure bands, OEB, NOAAs, nano-objects, aggregates, agglomerates, control banding, occupational hygiene, exposure assessment.
Open preview (PDF)Nanotechnologies — Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs)
