ATALANTE Intended use
- The Atalante system is intended to perform ambulatory functions, autonomously, for individuals having lower limb and trunk deficiency in clinical or research healthcare institutions under the supervision of trained healthcare professionals.
- The Atalante system is not intended for 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: 11/01/2021
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