For a complete CE-documentation, respective testing certificates are required which verify product safety. It implies that the product neither constitutes safety risk for the patient nor has an effect on other medical appliances (e.g. electromagnetic compatibility).
Typically, these are medical tests for wheelchairs, wheeled walkers (rollators) and scooters (according to EN ISO 11199, EN 12182, 12183 and 12184); biocompatibility tests according to EN ISO 10993-xx (skin tolerance) as well as electric tests according to EN 60601.
According to product type and its respective classification, the applicable test standards can be identified. When these are defined, manufacturers need to find the right testing laboratories to conduct these tests or, in specific cases (depending on the classification), they have to find an accredited test house.
Due to numerous standards and their versatile content, it is difficult to keep an overview and to determine the relevant test standard. BEO BERLIN® can guide you through the “jungle of standards”. We can find the applicable test and the respective test laboratories.