Overview
ISO/TR 17302:2015 - Nanotechnologies: Framework for identifying vocabulary development for nanotechnology applications in human healthcare provides a taxonomic framework to guide the development and harmonization of vocabulary for clinical uses of nanotechnology. Rather than attempting a formal definition of “nanomedicine,” the Technical Report maps where nanotechnologies intersect the clinical value chain and identifies terminology needs to improve communication across research, clinical, regulatory and industry stakeholders.
Key topics
- Scope and purpose: Focuses on clinical applications of nanotechnologies in human healthcare and on where these technologies will impact the practice of medicine.
- Clinical value chain taxonomy: Divides applications into four segments - prediction & prevention, diagnosis, therapy, and monitoring - and describes how nanotechnologies map to each segment.
- Terminology development: Provides a framework and method for identifying terms that need definition and harmonization within each segment of the clinical workflow.
- Technical observations: Notes practical size considerations (e.g., commonly referenced ~100 nm boundary from ISO nanoscale definitions) and recognizes variability in biological contexts where larger particles may be relevant.
- Supporting resources: Annexes list existing nanomedicine terms and ontology/terminology resources to aid standardizers and subject-matter experts.
Practical applications
ISO/TR 17302:2015 is intended to improve clarity and interoperability across sectors by enabling consistent vocabulary for:
- Diagnostics - in vivo and in vitro nanoparticle imaging, biosensors and analyte detection workflows.
- Therapeutics - targeted drug delivery systems, nanoscale scaffolds, coatings and material-modified implants.
- Prevention - nano-coatings, antiseptics and surface nanotexturing for infection control and vaccine-related technologies.
- Monitoring - post-therapy surveillance using nanotechnology-enabled sensing and biomarkers.
The framework helps authors of guidance, labeling, clinical protocols and regulatory submissions to use consistent, unambiguous terminology.
Who should use this standard
- Medical and life-science researchers and developers of nanotechnology-enabled products
- Pharmaceutical, diagnostic and medical device manufacturers
- Regulatory professionals, patent attorneys and patent offices
- Institutional review boards, ethics committees and accreditation organizations
- Standards developers and informatics/ontology specialists working on nanomedicine terminology
Related standards and resources
ISO/TR 17302 complements other ISO nanotechnology work and terminology/measurement documents by focusing specifically on vocabulary needs in clinical healthcare. Users should consult existing ISO nanoscale and nanotechnology guidance and ontology resources listed in the Technical Report’s annexes when developing harmonized definitions.
Keywords: ISO TR 17302:2015, nanotechnologies, nanomedicine vocabulary, clinical value chain, diagnostics, therapy, healthcare terminology, nano-standards.