Abstract
AbstractWearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applications (and also for industrial, assistive, or military purposes), thus governed by regulations for medical devices and their conformity assessment. On top of that, manufacturers must also specify if their exoskeletons can be categorized as machines and, therefore, additionally apply a number of requirements mandated from machinery regulations. This work focuses on capturing both the abovementioned requirements enacted by the Medical Devices Directive 2017/745 and the Machinery Directive 2006/42 into a single framework. It formalizes into Rules the Conformity Assessment procedures regarding the marketability of exoskeletons indicated by the CE marking (“Conformité Européene”). These Rules, expressed in the Positional-Slotted Object-Applicative (PSOA) RuleML code, were complemented by representative Facts based on real-life cases of commercialized exoskeletons. Additional Exoskeletons Facts can be included by users from other forms (such as MS Excel) and translated into the PSOA RuleML code through the provided Python script. The open-source Exoskeletons’ CE mark (ExosCE) Rules KB was tested by querying in the open-source PSOATransRun system. The ExosCE Rules prototype can assist in the compliance process of stakeholders and in the registration of exoskeletons with a CE mark.
Highlights
Wearable robots aim to significantly improve the quality of users’ life by assisting, augmenting, or enhancing mobility and motion in various human movement applications and scenarios [1,2].At the present time, robots’ adoption is not widespread
Such cases are the “HAL for Labor/Care Support” from Cyberdyne, which received ISO 13482:2014 as a wearable robot, the “Medical Robot Suit HAL,” which received a CE marking under the Medical Devices Directive 2017/745/EC (MDD), the ReWalk from ArgoMedical categorized as the Class II (USA) medical device, the Rex Bionics as Class I (EU, USA, and Australia) for rehabilitation use, and the EksoLegs from Ekso Bionics as Class I (USA and Australia) and Class IIa (EU) for rehabilitation use in hospitals
The complete KB coupled with the database source, the excel sheet for the requirements’ checklist, the Python script for converting the database into a Positional-Slotted ObjectApplicative (PSOA) RuleML code, and a Readme File can be found at http:// users.ntua.gr/salmpani/Exoskeletons’ CE mark (ExosCE)/
Summary
Wearable robots aim to significantly improve the quality of users’ life by assisting, augmenting, or enhancing mobility and motion in various human movement applications and scenarios [1,2]. The main objectives of our work are to: – explore the exoskeleton-relevant regulatory framework and provide a brief review on the directives and the emerging international safety requirements, – present an example case study on commercializing exoskeletons, – develop a combined computational rule format and form a Knowledge Base of the core parts of the MDD 2017/745 and the MD 2006/42 realized with PSOA Rules and Facts about exoskeletons, – create a user-friendly checklist for the Conformity Assessment requirements by using MS Excel and a Python script to automatically translate the checked requirements into a PSOA RuleML code, – test with PSOATransRun queries the accuracy, interpretability, and reliability of the described computational model that allows its validation by humans, and – create a basis for computational guidance, aiming to assist stakeholders in the compliance procedure of exoskeletons for the CE mark. Appendix A provides representative fragments of the ExosCE Rules KB
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