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Nanotechnologies in the field of medicine have also been considered by standardisation bodies.At European level, the European Standardisation Committee (CEN) has a dedicated technical committee TC 352 that has been working with nanotechnologies.While the organisation’s working group WG3 is focussing on ‘Health, Safety and environmental aspects’, it has not yet published any document directly relating to nanomedicine.
At the international level, the International Organisation for Standardisation (ISO) is responsible for the standardisation of nanotechnologies with its TC 229.Similar to CEN/TC 352, the International Technical Committee comprises a working group on health safety and environmental aspects.
The seventh part of the ISO 80004 series on nanotechnology vocabulary is dedicated to nanomedicine (ISO/TS 80004-7:2011 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare).It defines general terms such as ‘nanointervention’ (i.e. manipulation at the cellular and subcellular level using nano-scale properties of materials or systems), as well as terms related to structural entities (e.g. ‘stealth nano-object’, ‘nanoarray’, ‘nanopore sensor’, ‘nanocapsule’, etc.).
While standardisation bodies have nanotechnology committees, nanotechnologies are cross-sectoral and are therefore relevant in other specific TCs of ISO. The EU FP7 project NanoSTAIR identified all ISO/TCs working with nanotechnologies.At the international level, the consortium identified several relevant technical committees working with health issues :
- ISO/TC 150 Implants for surgery
- ISO/TC 150/SC2 Cardiovascular implants and extracorporeal systems
- ISO/TC 194 Biological evaluation of medical devices
- ISO/TC 215 Health informatics
ISO/TC 194 is also currently developing a specific guidance on nanomaterials for the biological evaluation of medical devices (ISO/NP TR 10993-22); this document is still in draft stage.