ATALANTE Intended use
- The Atalante system is intended to perform ambulatory functions, mobility exercises and adapted physical exercises, hands-free, for individuals having lower limb and trunk disability in rehabilitation centers, city cabinets or adapted physical exercise centers under the supervision of trained operators.
- The Atalante system is not intended for non-adapted sports, aggressive use, stair climbing or usage in other outside premises.
CE 2797List of safety and performance standards are technical specification, approved by a certification body, where its implementation is not mandatory. It attests the compliance of a product/service/process/system to a set of requirements. Applicable standards to medical devices and particularly to Wandercraft medical devices are the following (non-exhaustive list): - EN ISO 13485 : 2016 - Medical devices – Quality management systems – Requirements for regulatory purposes - EN ISO 14971 : 2019 - Medical devices – Application of risk management to medical devices - EN 60601-1 : 2006 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance - EN 60601-1-2:2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and test - EN ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - IEC 80601-2-78:2019 Medical electrical equipment -- Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability - EN 62304 : 2006 - Medical device software – Software life cycle processes Date of last update: 01/07/2021
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