Other care appliances

CATEGORY: Electrical appliances and equipment

Product definition

This factsheet applies to other care appliances such as electrical heating blankets, pads and clothing, foot massagers, hand-held massagers, massage beds and chairs, massage pads and massage belts, oral irrigators and toothbrushes, electrical foot warmers and heating mats and electric toilets and electric equipment for use with conventional toilets.

NB! Appliances that are intended for treatment or alleviation of diseases, injuries or disabilities are considered as medical devices. They cannot legally be marketed in the EU as “other care appliances”.

NB: For this product category, certificates are only recommended as well as involving a third party laboratory in the conformity assessment.

Common risks of care appliances

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

1. Electrical risks

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

2. 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.

3. 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.

4. Optical risks

Optical radiation (primarily lasers or blue light sources in the product) can cause damage to sight.

Further risks if the care appliance 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.

See further risks

This is a list of examples of common risks. However, the manufacturer has to carry out an assessment of the care appliance 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 care appliances offered for sale in the European Union are available on the Safety Gate website. Type ‘care appliance’ 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 care appliance 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 care appliances must meet before they can be marketed in the EU. Care appliances 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 (GPSR). The Directive lays down that only safe consumer products can be marketed in the EU. Care appliances must comply with the general safety requirement set out in this Directive. More specific details can be found here.

Applicable standards

“European standards” exist in the EU for care appliances . Care appliances complying with these standards are presumed to be in conformity with the essential safety requirements set out in the Low Voltage Directive if the standards are referenced in the Official Journal of the European Union (OJEU).
It is important to note that the latest edition of the standard referenced in the OJEU (including any amendments) applies.

Note: The following site of CEN CENELEC (the European standardisation organisation) provides links to the national standardisation bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

The following standards apply to care appliances (and others may apply in specific circumstances):

EN 60335-1:2012

This standard describes the general safety requirements for electrical appliances. It is the base standard that has to be read in conjunction with one of the following part 2 standards depending upon the type of appliance.

60335-2-17:2013

This standard describes specific safety requirements for heating blankets, pads, clothing and similar flexible heating appliances.

EN 60335-2-32:2003

This standard describes specific safety requirements for massage appliances including for examples foot massagers, hand-held massagers, massage beds, massage chairs, massage pads and massage belts.

EN 60335-2-52:2003

This standard describes specific safety requirements for oral hygiene appliances such as oral irrigators and toothbrushes.

EN 60335-2-81:2003

This standard describes specific safety requirements for foot warmers and heating mats.

EN 60335-2-84:2021

This standard describes specific safety requirements for electric toilets and electric equipment for use with conventional toilets, including for example automatic seat covering devices, chopping units, heated seats, pumping units, water heaters for spray seats and spray seats.

EN 62311:2008

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

However, the standard series covers other safety issues and manufacturers are strongly advised to consult the whole standard.

Other legislation of relevance:

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
Ecodesign regulations – establishes ecodesign requirements for energy-related products
Energy labelling regulations – establishes the requirements and criteria for energy labelling of energy-related products
Waste Electrical and Electronic Equipment (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 (GPSR), even if it falls outside of the voltage limits specified in the Low Voltage Directive.

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

See additional requirements

Mandatory labelling & warnings

The following are obligatory:

CE Marking is obligatory for all care appliances that fall within the scope of the LVD. Before marking the care appliance with the CE mark, the manufacturer needs to identify all the applicable legal requirements, verify the conformity of the care appliance 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 care appliance to draw attention of users to risks and how to avoid injury.

General safety requirements

To ensure that manufacturers produce only safe care appliances there are also a range of general requirements to be fulfilled. These are explained in the following factsheets and need to be read in conjunction with this factsheet:

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

Disclaimer

The provided information was updated in 2024. 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.