Standards - EUON
Health
This section gives an overview of standards in the field of health published by the international standardisation bodies from 2017–2020. Fourteen health standards were published by ISO (8), CEN (4) and OECD (2). Most standards addressed the issue of health and safety when being exposed to nanomaterials. Set up and measurements in human health toxicity studies of nanomaterials were covered in most standards issued between 2017–2020. Many standards addressed two routes – inhalation and dermal exposure.
Most standards published in 2017–2020 were developed by ISO. Several technical committees contributed to nanomaterial standardisation work in the health field:
- ISO/TC 229 – Nanotechnologies.
- ISO/TC 194 – Biological and clinical evaluation of medical devices.
- ISO/TC 146 – Air quality.
Between 2017–2020, the ISO standards mostly focused on the exposure to nanomaterials. However, two standards addressed nanomaterials in medical applications – medical devices and biosensing. The following health standards were published by ISO in the period under analysis:
- ISO (2017). ISO/TR 10993-22. Biological evaluation of medical devices — Part 22: Guidance on nanomaterials. Available at: https://www.iso.org/standard/65918.html
- ISO (2017). ISO/TR 19601. Nanotechnologies — Aerosol generation for air exposure studies of nano-objects and their aggregates and agglomerates (NOAA). Available at: https://www.iso.org/standard/65451.html?browse=tc
- ISO (2017). ISO/TR 19057. Nanotechnologies — Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability. Available at: https://www.iso.org/standard/63836.html?browse=tc
- ISO (2017). ISO/TS 21623. Workplace exposure — Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA). Available at: https://www.iso.org/standard/71272.html
- ISO (2018). ISO/TR 12885. Nanotechnologies — Health and safety practices in occupational settings. Available at: https://www.iso.org/standard/67446.html?browse=tc
- ISO (2018). Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles. Available at: https://www.iso.org/standard/63698.html?browse=tc
- ISO (2019). ISO/TR 22019. Nanotechnologies — Considerations for performing toxicokinetic studies with nanomaterials. Available at: https://www.iso.org/standard/72381.html?browse=tc
- ISO (2020). ISO/TS 21412. Nanotechnologies — Nano-object-assembled layers for electrochemical bio-sensing applications — Specification of characteristics and measurement methods. Available at: https://www.iso.org/standard/70874.html?browse=tc
All standards published by CEN focused on the inhalation and dermal exposure to nanomaterials. Interestingly, one standard was specifically addressing the exposure to nanomaterials in textile products. The following committees contributed to developing these standards:
- CEN/TC 352 – Nanotechnologies.
- CEN/TC 248 – Textiles and textile products.
- CEN/TC 137 – Assessment of workplace exposure to chemical and biological agents.
- CEN published the following health standards from 2017–2020:
- CEN (2018). CEN ISO/TS 21623. Workplace exposure — Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017). Available at: https://standards.cencenelec.eu/dyn/www/f?p=205:110:0::::FSP_PROJECT:38306&cs=1D2F94781F706E045B877052D323189AF
- CEN (2018). EN 17058. Workplace exposure — Assessment of exposure by inhalation of nano-objects and their aggregates and agglomerates. Available at: https://standards.cencenelec.eu/dyn/www/f?p=205:110:0::::FSP_PROJECT:37668&cs=19FEB6BCFB77F685FE126B3A506F05BAC
- CEN (2018). Workplace exposure — Measurement of exposure by inhalation of nano-objects and their aggregates and agglomerates — Metrics to be used such as number concentration, surface area concentration and mass concentration. Available at: https://standards.cencenelec.eu/dyn/www/f?p=205:110:0::::FSP_PROJECT:40120&cs=11B1E52FDA8F8DC995066C158A4434884
- CEN (2019). CEN/TR 17222. Textile products and nanotechnologies — Guidance on tests to simulate nanoparticle release — Skin exposure. Available at: https://standards.cencenelec.eu/dyn/www/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:37917,6229&cs=125C978D064AC99A7064E74456BA72A91
In 2017–2020, OECD published two test guidelines for human toxicity studies of nanomaterials addressing one exposure rout – inhalation:
- OECD (2018). Test guideline 412. 28-day (subacute) inhalation toxicity study. Available at: https://www.oecd-ilibrary.org/docserver/9789264070783-en.pdf?expires=1648036564&id=id&accname=guest&checksum=FE20514124EFDF88FE09C7452B695342
- OECD (2018). Test guideline 413. 90-day (subchronic) inhalation toxicity study. Available at: https://www.oecd-ilibrary.org/docserver/9789264070806-en.pdf?expires=1648036652&id=id&accname=guest&checksum=76109787501BA387F52F34F62BA84347