Atalante is CE marked in Europe for the intended use indicated below:
- The Atalante system is designed to perform ambulatory functions, mobility exercises and hands-free adapted physical exercises on patients with motor deficiencies of the lower limbs and trunk in rehabilitation centres, city practices and adapted physical exercise centres under the supervision of trained operators.
- The Atalante system is not intended for non-adapted, violent sports activities, climbing stairs or outdoor use.
Class of the device
Class IIa device [Annex VIII, Medical Device Regulation 2017/745].
List of safety and performance standards are technical specifications, approved by a certification body, where their implementation is not mandatory. It attests the conformity of a product/service/process/system to a set of requirements. The standards applicable to medical devices, and in particular to the Wandercraft medical device, 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 testing
- 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 illness, injury or disability
- EN 62304: 2006 - Software for medical devices - Software life cycle processes
Date of last update: 01/07/2021