The device satisfies the requirements of the standard EN ISO 11199:2005 - Walking aids manipulated by both arms as indicated in Table 1. Numerical values of the specification are not provided for avoiding any infringement of the copyright.
Table 1: compliance with the EN ISO 11199:2015
According to the Product Requirements, the material used shall comply with ISO 10993 Biological evaluation of medical devices (Table 2).
Table 2: compliance with the EN ISO 10993