( PR4US.com | Press Release | 2019-05-03 15:57:57 )
Electric wheelchair manufacturers are reminded that their products must be safe, robust and conform to the requirements in Annex I of the European Medical Device Directive 93/42/EEC before they can be offered onto the market in the European Union (EU). This requires adequate testing against the correct standards.
Under the European Medical Directive, wheelchairs are classified as Class I. This means the manufacturer is responsible for declaring the product complies with the directive. Furthermore, because it is supplied in non-sterile condition and does not have a measuring function, the manufacturer does not need to consult an independent Notified Body.
Under the terms of the European Medical Directive, manufacturers must compile a technical dossier containing, inter alia, a risk analysis and their own Declaration of Conformity (DoC) that the product conforms to applicable standards. Following this, the manufacturer can place the CE mark on their product to show compliance.
Wheelchairs and scooters are classified according to their intended use:
• 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
To learn more about these classes, view the SGS article: “Accessing the EU Marketplace with Safe and Compliant Electric Wheelchairs.”: [www.sgs.com/en/news/2019/04/accessing-the-eu-marketplace-with-safe-and-compliant-electric-wheelchairs]
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
First published in 1999, EN 12184 is now on its fourth iteration – EN 12184:2014. It covers:
• Electrically powered wheelchairs
• Electrically powered scooters with three or more wheels
• Battery chargers for the above
It applies to products where the maximum speed does not exceed 15km/h and that are intended to carry only one person with a mass no greater than 300kg.
The standard covers several aspects of wheelchair design, including:
• Biocompatibility and toxicity
• Safety of moving parts
• Prevention of human body part entrapment
• Clinical evaluation
• Risk analysis
The standard largely relies on normative reference documents, especially for test methods. In especial, it references the ISO 7176 series, either whole or in part. Therefore, evaluation against these will confirm adherence to EN 12184.
The ISO 7176 documents referenced in EN 12184 are:
• Mechanical tests
o ISO 7176-1 Static stability
o ISO 7176-8 Test methods for static, impact and fatigue strengths
o ISO 7176-11 Test dummy
o ISO 7176-13 Determination of coefficient of friction of test surfaces
o ISO 7176-15 Information disclosure, documentation and labeling
o ISO 7176-22 Set-up procedures
• Electrical tests
o ISO 7176-2 Dynamic stability
o ISO 7176-3 Test for determination of the effectiveness of running brakes
o ISO 7176-4 Energy consumption, theoretical distance range
o ISO 7176-6 Maximum speed, acceleration and deceleration
o ISO 7176-9 Climatic tests
o ISO 7176-10 Obstacle-climbing ability
o ISO 7176-14 Power and control systems for electrically powered wheelchairs and scooters
o ISO 7176-21 Electromagnetic compatibility
To gain access to markets in the EU, manufacturers of electrical wheelchairs must ensure they conform to the requirements of the European Medical Directive. While it is not mandated that they must consult an independent Notified Body, they must perform correct and adequate testing to ensure products are safe, robust, and adhere to applicable regulations.
SGS Electrical and Electronic Testing Services
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. Learn more about SGS Electrical and Electronic Testing Services: [www.sgs.com/ee]
For more information, please contact:
AJ Yang 楊正吉
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.