The law
One European limit binds. It is written for workers, and we design everyone to it.
Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of workers to artificial optical radiation is the only legally binding exposure limit in the EU.
ANNEX I, TABLE 1.1
30 J/m²
Effective dose limit per eight-hour day, 180–400 nm, skin and eye — that is 3 mJ/cm².
ANNEX I, TABLE 1.2
S(222) = 0.1316
The spectral weighting the Directive assigns to 222 nm.
3 ÷ 0.1316
22.8 mJ/cm²
The permitted unweighted dose at 222 nm over eight hours. Rounded to 23 in most literature.
22.8 ÷ 28,800 s
0.79 µW/cm²
The maximum intensity if a lamp ran continuously for the whole eight hours. Lamps are stronger than this — which is why duty cycle exists.
Derivation as set out by UV Medico A/S in "Confirmation that UV222 complies with UVC radiation limit values", 22 September 2021, citing Annex I of the Directive. In Europe these limits apply in place of Chapter 4 of IEC 62471: the CENELEC common modification to EN 62471:2008 says so on its endorsement page.
Greece
Transposed by Presidential Decree 82/2010 (ΦΕΚ 145/Α, 1 September 2010), "Ελάχιστες προδιαγραφές υγείας και ασφάλειας όσον αφορά στην έκθεση των εργαζομένων σε κινδύνους προερχόμενους από φυσικούς παράγοντες (τεχνητή οπτική ακτινοβολία)". This is the text a plant's safety officer will ask for.
Cyprus
Transposed by Regulations of 2010 made under the Safety and Health at Work Law. The Department of Labour Inspection publishes a non-binding guide of good practice for applying Directive 2006/25/EC.
A note on scope. The Directive protects workers. Patients, visitors and customers are not formally within it — but there is no other European limit, so every Icarus 222 installation is designed to the same 22.8 mJ/cm² per eight hours at a standing eye height of 180 cm, for everyone in the room.
How the limit is held
Measured lamp, configured duty cycle, two sensors, trained installer.
In the manufacturer's own words, from the compliance letter of 22 September 2021.
"Each UV222™ lamp is measured in a UV-calibrated goniometer from Viso Systems. From these measurements, both the spatial distribution of light and the spectral intensity within 190–850 nm are known."
"The brightness of the lamp is strongest in the center position perpendicular to the front glass and is emitted at a distance of one metre: 13 µW/cm². Thus, for distances of less than about 4 metres, the lamp will exceed the limit value for UVC irradiation if the lamp is switched on continuously."
"To accommodate this, the lamp software is configured when installing for an operation cycle determined by the lamp's location in the room … the distance from the lamp to the standard 'safety eye height', i.e. 180 cm, as well as the maximum useful life of the room is entered. From these two inputs, the proportion of time the lamp must be switched on to keep the irradiated dose below the limit value is calculated."
"To ensure that these values are entered correctly and in such a way that the limit value is not exceeded, the lamp is installed solely by electrical installers undergoing training at UV Medico. As an additional safety, each lamp has a LIDAR (16-point laser rangefinder) and a motion sensor."
UV Medico A/S, Confirmation that UV222™ complies with UVC radiation limit values, 22 September 2021 (English translation). Icarus 222's installers are trained by UV Medico.
The limits, side by side
Three bodies publish a 222 nm limit. Only one is law here.
| Source | Eye, 8 h | Skin, 8 h | Standing |
|---|---|---|---|
| Directive 2006/25/EC · ICNIRP | 23 mJ/cm² | 23 mJ/cm² | Binding law for workers in Cyprus and Greece. What every Icarus 222 installation is designed to. |
| ACGIH TLV 2022 (United States) | 160 mJ/cm² | 480 mJ/cm² | Voluntary US threshold, raised at the end of 2021. About 7× and 21× the European limit. No legal standing in the EU. |
| ACGIH TLV 2021 | 23 mJ/cm² | 23 mJ/cm² | The US value in force when the 2021 compliance documents were written; identical to ICNIRP at the time. |
Figures as published by UV Medico A/S, "What is the current TLV?", uvmedico.com knowledge base: "ACGIH 2022 Threshold Limit Value for 222 nm is: Eyes: 160 mJ/cm², Skin: 480 mJ/cm²"; "ICNIRP Threshold Limit Value for 222 nm is: 23 mJ/cm²". The Directive's exact figure is 22.8 mJ/cm².
CE marking
What the EU Declaration of Conformity covers — and what kind of product this is.
"UV Medico products are developed, tested and CE marked to international standards for luminaire and photobiological safety. Every UV222 installation is designed with an installation-specific exposure assessment." — uvmedico.com/compliance
| EU legislation | Harmonised standards cited | What it means |
|---|---|---|
| Low Voltage Directive 2014/35/EU | EN 60335-1 (household and similar electrical appliances — general) · EN 60335-2-65 (air-cleaning appliances) | UV222 is placed on the market as an electrical air-cleaning appliance. |
| EMC Directive 2014/30/EU | EN 62233 · EN 61000-3-2 · EN 61000-3-3 · EN 55014-1 · EN 55014-2 | Electromagnetic compatibility — the full appliance set. An EMC test report can be requested for endoscopy and ICU settings. |
| RoHS 2011/65/EU | EN 50581 | Restriction of hazardous substances. The lamp is mercury-free. |
| Declared in addition | ISO 15858 · IEC 62471 · IEC PAS 63313 · ACGIH TLV | Stated as complied with on the Declaration. See the next section for exactly what each means. |
EU Declaration of Conformity, UV Medico A/S, Åbyhøj, Denmark, signed 28 April 2021 — product "Germicidal Compact Far UV light, Type: UV222". A manufacturer's self-declaration, which is the normal route under the LVD and EMC Directives. UV Medico's current published design standards also list EN IEC 60598-1, EN IEC 60598-2, EN IEC 62471-6 and ANSI/IES RP-27.1-22.
Not a medical device
UV222 is declared under the appliance standards, not under the Medical Device Regulation 2017/745. It carries CE as disinfection equipment for rooms, and it makes no clinical claim for any patient. We say this plainly to hospitals, because a QA committee will check.
The lamp inside carries no CE of its own
The Care222® module is a component. Its manufacturer, Ushio Inc. of Himeji, Japan, declares it under RoHS 2011/65/EU and states that as a spare part it is not CE marked as finished equipment. Full CE conformity belongs to the finished UV222 device, and that is where it sits.
Standards, stated precisely
Three standards are named on every far-UVC datasheet. Here is what each one actually establishes.
ISO 15858:2016
UV-C devices — safety information — permissible human exposure
A seven-page requirements standard for any UVC device that can expose people. UV222 is designed and configured to meet its exposure requirements (clause 5.2), as carried to 222 nm through the spectral weighting of the Directive; that is attested by the manufacturer and by Aarhus University's Department of Electrical and Computer Engineering (17 December 2021).
What it is not: a certificate. There is no such thing as "ISO 15858 certified". Anyone who says so is describing something that does not exist.
IEC / EN 62471
Photobiological safety of lamps and lamp systems
Defines weighting functions, exposure limits, measurement methods and risk groups for any lamp. The Declaration states conformity. The lamp as a continuous source is assessed under it; as an installed system with dose control, the effective exposure at 180 cm is held below the Directive's 30 J/m² per eight hours — which, in Europe, are the limits that apply in place of the standard's own Chapter 4.
What we do not claim: an "Exempt" risk group. No effective germicidal UVC source is exempt as a bare, continuous lamp. The safety is in the system.
IEC PAS 63313
Position statement on germicidal UV-C irradiation — safety
A publicly available specification setting out the safety position for germicidal UVC. Declared as complied with. It carries no certificate either.
ICNIRP guidelines and the ACGIH TLVs are exposure guidelines from scientific bodies, not standards. The Directive adopted ICNIRP's figures into law; ACGIH's are advisory and American.
The manufacturer
UV Medico A/S, Denmark
Designs and manufactures far-UVC solutions in Åbyhøj, Aarhus. Certified to ISO 9001:2015 (quality management) and ISO 14001:2015 (environmental management) — certificates C733217 and C733218 as published on uvmedico.com. Member of R3 Nordic, PDA, ISPE, IUVA, Advanced-UV and EPIC.
"UV222™ operates in compliance with regulations from local European authorities regarding exposure to artificial optical radiation, including the Danish Working Environment Authority."
uvmedico.com/compliance
The lamp inside
Ushio Care222®, Himeji, Japan
Module UXFL70-222B4-UIA, manufactured by Ushio Inc. at Himeji, Hyogo, and distributed in Europe by Ushio Europe B.V. Ushio's declaration of 28 December 2020 covers RoHS 2011/65/EU and lists the bill of materials: a bandpass filter and a deep-UV cut filter — the two filters that make the source "filtered" — a quartz window, and a krypton–chlorine–neon gas fill. No mercury.
Ushio Inc. Declaration of Conformity, UXFL70-222B4-UIA, 28 December 2020, test report XF-20201109-2.
The dossier
Documents available on request — and what each one proves.
We would rather you knew the limits of each document before you asked for it than after.
| Document | Issued by | Proves |
|---|---|---|
| EU Declaration of Conformity — UV222 | UV Medico A/S · 28 Apr 2021 | CE under LVD, EMC and RoHS with the harmonised standards above; ISO 15858, IEC 62471 and IEC PAS 63313 declared in addition. |
| Confirmation of compliance with UVC radiation limit values | UV Medico A/S · 22 Sep 2021 | The Directive derivation to 22.8 mJ/cm² and 0.79 µW/cm²; goniometer measurement; 13 µW/cm² at 1 m; duty cycle; LIDAR and motion sensor. |
| UV222 in full compliance with ISO 15858 | Aarhus University, Dept. of Electrical and Computer Engineering · 17 Dec 2021 | A university attestation that the exposure requirements of ISO 15858 are met at 222 nm. Scientific attestation, not third-party certification. |
| ISO 9001:2015 and ISO 14001:2015 certificates | Certification body, for UV Medico A/S | Quality and environmental management systems of the manufacturer. |
| Confederation of Danish Industry attestation | Dansk Industri · 17 Sep 2021 | That UV Medico A/S is a duly existing Danish company (CVR 42602582), entitled to manufacture and export ultraviolet light fixtures for germicidal purposes. |
| Ushio Care222® module Declaration of Conformity | Ushio Inc., Himeji · 28 Dec 2020 | RoHS conformity of the module and its bill of materials, including both filters. |
| Effectiveness of UV222 lamps | Aarhus University, Institute for Biomedicine, for UV Medico | Laboratory and field reductions of SARS-CoV-2 and surface bacteria. Authors are affiliated with UV Medico and say so; not peer-reviewed. For independent evidence see the Technology page. |
| Icarus 222 commissioning record | Icarus 222 · per installation | Point measurements at 1.83 m with a 222 nm-selective radiometer, lamp configuration, signage and the client's signed training record — in line with ISO 15858 clause 4.4. |
Need the dossier for a supplier audit?
Tell us which documents your QA requires and we will send the current versions with a cover note on what each covers.