Far-UVC Compliance and Certifications

Yes. UV Medico A/S is certified to ISO 13485:2016 by DNV (certificate C814005), valid from 30 September 2026 to 29 September 2029.

ISO 13485:2016, ISO 9001 and ISO 14001. UV222™ products are CE marked and tested for RoHS (2011/65/EU), the Low Voltage Directive (2014/35/EU) and EMC (2014/30/EU). UV222™ lamps are mercury-free.

The certified scope is: “Manufacture, Sales and Distribution of Far-UVC solution for medical devices disinfecting, cleaning and rinsing.” It describes the activities our quality management system covers: manufacture, sales and distribution. It does not classify UV222™ products as medical devices (see the next question).

No. ISO 13485 certifies how we work: the quality management system behind our manufacturing, sales and distribution, held to the standard used in healthcare manufacturing. UV222™ products are not designed as medical devices; they are CE marked under the applicable EU product directives. What customers get is the quality control, traceability and documentation that hospitals and GMP cleanrooms expect from their suppliers.

Two bodies set 8-hour limits at 222 nm:

Which limit should you use?

• In the EU: EU Directive 2006/25/EC makes the ICNIRP values legally binding for workplace exposure. Use these unless your national authority states otherwise.
• Outside the EU: follow your national regulation and internal SOPs (Standard Operating Procedure). Where none applies, the ACGIH TLVs are a widely used occupational reference, for example in the US.
• Why the values differ: the ICNIRP values date from 2004 and cover the broad UV range. The ACGIH 2022 values are newer and specific to 222 nm, based on more recent research, which is why they are higher.

Not sure which limit applies to your site? Our team can advise as part of the installation-specific exposure assessment. Contact us →

Every UV Medico UV222™ installation includes an installation-specific exposure assessment:

1. We measure each product’s spectrum and light distribution in our own facilities and calculate its effective exposure limit.
2. Every standard fixture comes with an individual light measurement report.
3. We simulate lamp placement, room layout and reflections to avoid overexposure hot spots.
4. The lamp software calculates the time-integrated dose from duty cycle and occupancy-sensor input.
5. On site, point measurements are taken with a meter calibrated to the UV222™ spectrum.

The krypton-chloride lamps used for Far-UVC emit mainly at 222 nm, but without filtering, they also emit a small amount of longer UV-C wavelengths. These penetrate deeper into skin and eyes and have much lower exposure limits, so they restrict how much light an unfiltered lamp can deliver. UV222™ uses an optical filter that concentrates the output at 222 nm.

The result: under the ACGIH TLV (2022), a filtered UV222™ lamp can deliver roughly 3–5 times more 222 nm light within the same 8-hour exposure limit than an unfiltered lamp.

In the EU, the ICNIRP-based limit applies (see “What are the exposure limits for 222 nm Far-UVC?” above).

Learn more about filtered UV222™ Far-UVC →

Far-UVC at 222 nm has been studied for more than 20 years. More than 100 peer-reviewed studies have been published, and approximately half of them focus on safety.

What the safety studies have actually tested (a few examples from these many studies):

• Long-term chronic exposure (66 weeks): Cancer-prone hairless mice exposed 8 h/day, 5 days a week, at up to 400 mJ/cm², above the ICNIRP limit. No skin cancer, precancerous lesions or excess mortality. (Welch et al. 2022)
• All skin tones: Live human skin from donors of differing age, sex and ethnicity (Fitzpatrick I–VI) dosed at 100 and 500 mJ/cm². No significant DNA damage at 100 mJ/cm² and minimal at 500 mJ/cm², consistent across all skin tones. (Buonanno et al. 2025)
• Extreme human over-exposure (nearly 800× the limit): A volunteer exposed his forearms to up to 18,000 mJ/cm², nearly 800 times the ICNIRP limit of 23 mJ/cm². No erythema at any dose; at 6,000 mJ/cm² a faint surface yellowing appeared and resolved within 24 hours. (Eadie et al. 2021)
• Photosensitive and broken skin: Patients with photosensitivity disorders dosed to the ICNIRP daily limit, plus open pressure ulcers and surgical sites. No erythema, no irritation and no delayed healing. (Christou 2025; Goh 2021; Fukui 2022)
• Eyes in real settings (36 months): Ophthalmologists working under filtered 222 nm lamps for three years, plus 37 office participants at 50 mJ/cm². No photokeratitis, cataract or irritation; the corneal damage threshold was more than 150× the limit. (Sugihara 2024; Kousha 2023; Kaidzu 2021)

Together, the studies show low to no risk for eyes and skin at exposures within the maximum exposure limits. As with any UV source, exposure must stay within the applicable limit, which is why every installation includes an exposure assessment.