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Approvals

CE

Trials are conducted in our factory and ensures the client that the product complies with European directive 93/42/CE relating to medical devices and to the NF Standard EN 12182 «Assistive products for persons with disability».

The test protocol provides a framework for general product design aspects (dimensions, ergonomics, aesthetics), deterioration related to the environment in which the product is used (corrosion, temperature, UV exposure), notions of mechanical resistance with safety margins for seats (static tests, dynamic tests, impact tests), surface biocompatibility with the creation of a comprehensive technical dossier (user instructions, labels, plans, materials certificates, risk analysis).

The products awarded with CE label have been tested for comfort of use.

PELLET ASC Laboratory Tests

Mechanical tests are carried out in our test lab. Results ensure the client that the product complies with an internal protocol which covers the same methods as those used by independent labs.

Tests are carried on a certified test bench. An initial protocol validates safe load (a static test ensures that there are no breaks, cracks, slackening nor product deformation). A second one validates a higher load reference ensuring that, with a tolerated deformation, no break, crack can obstruct the operation of the product)

As manufacturers, PELLET ASC certify that its products comply with European standard NF EN 12182.

We also certify that the materials and coatings used on our products conform to the standards below :