UV sanitisers and germicidal UV lamps

Product definition

TUV sterilisers (also known as UV sanitisers or germicidal lamps) are appliances used to decontaminate surfaces or air from for example SARS-CoV-2, by different techniques. The product category comprises two major product groups:

Devices that decontaminate surfaces with Ultraviolet light. These devices will normally be switched on by an operator for short periods of time.
Devices that decontaminate air. They are often mounted in a place out of reach, permanently switched on, and equipped with a small fan that creates an airflow to increase the efficiency.

This factsheet applies to devices connected to AC mains, devices connected through an adaptor, as well as battery operated devices.

The factsheet applies to devices that are intended for use in private homes, office or shop environments. It does not apply to devices that are intended for the health sector, e.g. hospitals.

Guidance on electrical products

A comprehensive guidance document has been produced which covers requirements applicable to products covered by this factsheet here

Common hazards of UV sterilisers

The most common hazards identified in this product sector are set out below.

1. Radiation risks:

Inadequate covering of the UV source exposing the operator or nearby people to UVC radiation.
Inadequate safeguards exposing the operator or nearby people to UVC radiation.
Generation of ozone in excess during operation of the device.
Risks caused by optical radiation (primarily near-UV radiation or blue light).

2. Electrical risks

Electrical, magnetic or electromagnetic disturbances emitted from the electronics can adversely affect persons, domestic animals, property and nearby electrical products.

3. Thermal risks:

Hot surfaces can cause burns.
Poorly insulated or fixed wires or substandard components can short circuit and create arcs or overheating, leading to fire.

4. Mechanical risks:

High sound pressure levels can cause damage to hearing.
Heavy products that are unstable can fall over and cause injuries.
Poor mechanical construction so that heavy equipment intended to be hung on a wall can fall down and cause injuries.
Surfaces, edges, corners with sharp edges, or other flaws can cause injuries.
Rotating parts can cause injuries while spinning.

Further risks if UV Sanitiser contains batteries:

Short-circuits in the internal wiring or electronics can cause overheating of batteries or explosion, leading to leakage of dangerous chemicals.
Accessible small batteries (AAA or smaller) can be put in the mouth and swallowed, causing choking and damage to the gastrointestinal tract.

Further risks if UV Sanitiser contains batteries

This is a list of examples of common risks. However, the manufacturer has to carry out an assessment of the UV sanitiser that covers all relevant risks that may be associated with the product and actions taken to mitigate these risks where possible. A general definition of risk and its relationship to hazards can be found in the factsheet on Risk management.

Examples of dangerous products

Specific examples of measures taken against dangerous UV sanitisers offered for sale in the European Union are available on the Safety Gate website. Type ‘UV sanitiser’ into the free text search box (but without the quotation marks) and select the ‘electrical appliances and equipment’ Product Category to view notified examples. A better understanding of mistakes made in the safety assessment on the UV sanitiser or its manufacture can help avoid their repetition.

Main applicable legislation

These products are governed mainly by the Low Voltage Directive (LVD). The Directive lays down the safety criteria that all UV sanitisers must meet before they can be marketed in the EU. UV Sanitisers must comply with the essential safety requirements set out in this Directive. More specific details can be found here.

In addition, if the electrical appliance and equipment is capable to communicate wirelessly (e.g. incorporates Bluetooth or Wi-Fi), it should meet the requirements of the Radio Equipment Directive.

Please also check the factsheet for Power Supplies, Chargers and Adaptors for safety requirements for the external power supply.

All other products (with a voltage rating below 50 V AC or 75 V DC) and risks not covered by the LVD, are governed by the General Product Safety Directive (GPSD). The Directive lays down that only safe consumer products can be marketed in the EU. UV sanitisers must comply with the general safety requirement set out in this Directive. More specific details can be found here.

Applicable standards

“Harmonised standards” exist in the EU for electrical products. An electrical product complying with these standards is presumed to be in conformity with the essential safety requirements set out in the applicable legislation if the standards are referenced in the Official Journal of the European Union (OJEU). Further information on, and the list of harmonised standards for electrical products is available.

There is no single harmonised standard that specifically applies to UV sterilisers. Instead, the user has to combine relevant safety requirements from different standards:

EN 60335-1:2012
The standard describes the general safety requirements for household electrical appliances.

EN 60335-2-109:2010
The standard describes the particular safety requirements for UV radiation water treatment appliances. It must be read in conjunction with

EN 60335-1:2012.
In particular clause 7 and clause 32 describe safety requirements that are relevant for UV sterilisers. However, the standard covers other safety issues and manufacturers are strongly advised to consult the whole standard.

EN ISO 15858:2016
The standard describes minimum human safety requirements for the use of UVC lamp devices.

EN 62311:2008
The standard describes measurement methods and safety requirements related to human exposure restrictions for electromagnetic fields (0 Hz – 300 GHz).

EN 62471:2008
This standard describes measurement methods and safety requirements related to photobiological safety of lamps and lamp systems.

The most recent and relevant harmonised version published on the OJEU should be applied to your product to ensure that it is provided with the presumption of conformity.

Note: The full text of European standards can only be purchased from a national standards body. The following site of CEN (the European standards body) provides links to the national standards’ bodies websites.

Other legislation of relevance:

While manufacturer’s need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

EMC (Electromagnetic Compatibility). – lays down requirements for emission of electromagnetic disturbances to the environment and immunity to electromagnetic disturbances in the surrounding environment. Electromagnetic immunity and disturbances for products incorporating a communications device are dealt with under the Radio Equipment Directive.
RoHS 2 Directive (Restriction of Hazardous Substances) – restricts the use of certain substances and chemicals in electrical and electronic equipment
Eco design Regulations – establishes ecodesign requirements for energy-related products
Energy labelling Regulations – establishes the requirements and criteria for energy labelling of energy-related products
The battery Directive – establishes rules for marking of batteries and treating of waste batteries and accumulators
WEEE– establishes rules for treating of waste electrical and electronic equipment, to contribute to sustainable production and consumption
Please note that every product must be safe for the consumers according to the General Product Safety Directive (GPSD) of the EU, even if it falls outside of the voltage limits provided in the paragraph above.

Additional requirements if the product contains batteries:

The Battery Directive Batteries commonly contain hazardous substances such as mercury, cadmium and lead, which when incinerated or placed in landfill can present a risk to the environment and human health. As a result, this Directive sets maximum quantities for certain chemicals and metals in certain batteries and creates rules covering matters such as labelling, documentation and marking requirements

Additional requirements if the product contains batteries

Mandatory labelling & warnings

The following are obligatory:

CE Marking is obligatory for all UV sanitisers that fall within the scope of the LVD. Before marking the UV sanitiser with the CE mark, the manufacturer needs to identify all the applicable legal requirements, verify the conformity of the UV sanitiser with these requirements, compile a technical documentation that evidences this and create a written declaration of conformity. When this has been done, he should affix the CE mark on the product. Refer to the factsheet on CE marking.
Information on the manufacturer and the importer is obligatory.
The crossed-out wheel bin is obligatory for all electronics to indicate that it must be disposed of according to the rules for handling of waste from electronic and electrical equipment.

Safety warnings and instructions are obligatory for many types of UV sanitiser to draw attention of users to risks and how to avoid injury.

General safety requirements

You may also visit the SPEAC ACADEMY to learn more about the EU Safety requirements.

Disclaimer

The provided information was updated in 2022. Please note that some of the provided information could change during possible subsequent revisions of legislation, standards, and guidance documents. For any updates of official information on the EU product safety rules, please follow the Link to the webpage of the European Commission.

This document was produced with the financial support of the European Union. Its contents are the sole responsibility of SPEAC project and do not necessarily reflect the views of the European Union.