Accessing the EU Marketplace with Safe and Compliant Electric Wheelchairs
Before electric wheelchairs can be offered onto the market in Europe, manufacturers must ensure they are safe and comply with the requirements of the EU Medical Device Directive.
Wheelchairs must be safe to use and robust enough to withstand the rigors of operating in a world where wheelchair access is often an afterthought. The world we live in is not designed with the wheelchair: surfaces are often rough and uneven, older buildings often have narrow doorways, and public transport is often difficult to access. In addition, the fact a user is often confined to the wheelchair for extended periods of time means they are subject to muscle cramps and pressure sores.
European Medical Device Directive
Before a wheelchair can be launched onto the market in the European Union (EU), it must conform to the necessary requirements contained within Annex I of the European Medical Device Directive 93/42/EEC.
As the name suggests, Directive 93/42/EEC covers a wide variety of medical products, which are classified according to the risk they present to patients and carers. Wheelchairs are categorized as Class I. This means that the manufacturer is responsible for declaring their product complies with Directive 93/42/EEC and, because the product is supplied in an unsterile condition and does not have a measuring function, they do not need to consult an independent Notified Body.
Instead, manufacturers must compile a technical dossier containing, inter alia, a risk analysis and their own Declaration of Conformity that the product conforms to applicable standards. Following this, the manufacturer can place the CE mark on their product to show compliance.
Applicable standards for wheelchairs and scooters are:
- EN 12183 for manual wheelchairs
- EN 12184 for electric wheelchairs and scooters
- ISO 7176-series – the internationally accepted series of standards that describe the various testing methods for wheelchairs and scooters
- Electrically powered wheelchairs
- Electrically powered scooters with three or more wheels
- Battery chargers for the above
It applies to these products if their maximum speed does not exceed 15km/h and they are intended to carry only one person with a mass no greater than 300kg.
The standard was first published in 1999 and covers requirements and test methods. The latest version, EN 12184:2014, is the fourth iteration, replacing EN 12184:2009, which had to be withdrawn by March 2017.
Wheelchair and Scooter Classes
These products are classified according to their intended use. Each class defines the requirements the wheelchair or scooter should conform to, to be able to perform its role.
The three classes are:
- Class A – indoor use
- Class B – some indoor environments and capable of some outdoor obstacles
- Class C – for traveling over longer distances and capable of negotiating outdoor obstacles. Often larger in size
The requires concerning dynamic stability, brake effectiveness, etc. are detailed in Table 1.
|Class A||Class B||Class C|
|Rated slope||Minimum 3°||Minimum 6°||Minimum 10°|
|Dynamic stability||3° minimum slope||6° minimum slope||10° minimum slope|
|Static stability||6° minimum slope||9° minimum slope||15° minimum slope|
|Parking brake effectiveness||6° minimum||9° minimum||15° minimum|
|- forwards horizontal||15 km/h||15 km/h||15 km/h|
|- reverse horizontal||70 % of maximum forward speed or 5 km/h whichever is lower||70 % of maximum forward speed or 5 km/h whichever is lower||70 % of maximum forward speed or 5 km/h whichever is lower|
|Obstacle climbing and descending ability|
|- minimum obstacle height||15 mm||50 mm||100 mm|
|Minimum theoretical continuous driving distance range||15 km||25 km||35 km|
|Ground unevenness||10 mm||30 mm||50 mm|
EN 12184 is concerned with several aspects of wheelchair design:
- Biocompatibility and toxicity
- Safety of moving parts
- Prevention of human body part entrapment
- Clinical evaluation
- Risk analysis
In large part the standard relies on normative reference documents, especially for test methods. The ISO 7176 series is used in many places, either whole or in part, and evaluation against these will confirm adherence to EN 12184.
The ISO 7176 documents referenced in EN 12184 are:
- Mechanical tests
- ISO 7176-1 Static stability
- ISO 7176-8 Test methods for static, impact and fatigue strengths
- ISO 7176-11 Test dummy
- ISO 7176-13 Determination of coefficient of friction of test surfaces
- ISO 7176-15 Information disclosure, documentation and labeling
- ISO 7176-22 Set-up procedures
- ISO 7176-2 Dynamic stability
- ISO 7176-3 Test for determination of the effectiveness of running brakes
- ISO 7176-4 Energy consumption, theoretical distance range
- ISO 7176-6 Maximum speed, acceleration and deceleration
- ISO 7176-9 Climatic tests
- ISO 7176-10 Obstacle-climbing ability
- ISO 7176-14 Power and control systems for electrically powered wheelchairs and scooters
- ISO 7176-21 Electromagnetic compatibility
Changes Introduced in the Fourth Edition of EN 12184
Stakeholders should be aware the fourth version of EN 12184, currently in effect, differs from the 2009 edition in two main ways. Firstly, it includes the latest editions of the ISO 7176 series standards. For example, ISO 7176-3:2012 has replaced ISO 7176-3:2003.
Secondly, manufacturers should also be aware that the controller in an electric wheelchair must conform not only to ISO7176-14 and ISO 7176-21, but also the software embedded in the wheelchair, or as an integral part of the wheelchair, must be developed and maintained in accordance with EN 62304:2006.
We offer a comprehensive range of services to help manufacturers of electric wheelchairs access the European market. Our experts are fully conversant with the requirements for the European Medical Device Directive and offer consultancy and testing solutions to help expediate your access to the market.
For more information, please contact:
AJ Yang 楊正吉
t: +886 4 2359 1515 ext 1405