{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T02:20:55Z","timestamp":1771294855823,"version":"3.50.1"},"reference-count":62,"publisher":"Walter de Gruyter GmbH","issue":"1","license":[{"start":{"date-parts":[[2020,10,7]],"date-time":"2020-10-07T00:00:00Z","timestamp":1602028800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Wearable robots are devices intended to improve the quality of users\u2019 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 (\u201cConformit\u00e9 Europ\u00e9ene\u201d). 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\u2019 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.<\/jats:p>","DOI":"10.1515\/pjbr-2020-0026","type":"journal-article","created":{"date-parts":[[2020,10,10]],"date-time":"2020-10-10T23:47:08Z","timestamp":1602373628000},"page":"414-427","source":"Crossref","is-referenced-by-count":5,"title":["ExosCE: A legal-based computational system for compliance with exoskeletons\u2019 CE marking"],"prefix":"10.1515","volume":"11","author":[{"given":"Sofia","family":"Almpani","sequence":"first","affiliation":[{"name":"Division of Information Transmission Systems and Material Technology, School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece"}]},{"given":"Theodoros","family":"Mitsikas","sequence":"additional","affiliation":[{"name":"Division of Information Transmission Systems and Material Technology, School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece"}]},{"given":"Petros","family":"Stefaneas","sequence":"additional","affiliation":[{"name":"Department of Mathematics, School of Applied Mathematics, National Technical University of Athens, Athens, Greece"}]},{"given":"Panayiotis","family":"Frangos","sequence":"additional","affiliation":[{"name":"Division of Information Transmission Systems and Material Technology, School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece"}]}],"member":"374","reference":[{"key":"ref121","year":"2009","journal-title":"\u201cValidating existing requirements for compliance with law using a production rule model,\u201d"},{"key":"ref201","article-title":"\u201cLower-limb exoskeletons: Research trends and regulatory guidelines in medical and non-medical applications,\u201d","volume":"vol. 14","year":"2017","journal-title":"International Journal of Advanced Robotic Systems"},{"key":"ref521","article-title":"\u201cTowards realising wearable exoskeletons for elderly people,\u201d","volume-title":"Proceedings of the Advances in Robotics 2019, AIR 2019","year":"2019"},{"key":"ref691","volume-title":"New Trends in Medical and Service Robots: Human Centered Analysis, Control and Design, Mechanisms and Machine Science","volume":"vol. 39","year":"2016"},{"key":"ref241","first-page":"pp. 26","article-title":"\u201cThe new European medical device regulation 2017\/745: main changes and challenges,\u201d","year":"Oct 2017","journal-title":"Clinical Researcher"},{"key":"ref431","first-page":"pp. 92","year":"2020","journal-title":"\u201cEthical, legal and social issues in wearable robotics: Perspectives from the work of the COST Action on Wearable Robots,\u201d"},{"key":"ref611","first-page":"pp. 1","volume-title":"\u201cISO 13482 \u2212 the new safety standard for personal care robots,\u201d","year":"2014"},{"key":"ref421","doi-asserted-by":"crossref","first-page":"pp. 19","DOI":"10.1109\/MRA.2017.2787222","article-title":"\u201cWearable robotics for motion assistance and rehabilitation [TC Spotlight],\u201d","volume":"vol. 25","year":"2018","journal-title":"IEEE Robotics Automation Magazine"},{"key":"ref751","journal-title":"\u201cFormalizing Air Traffic Control Regulations in PSOA RuleML,\u201d"},{"key":"ref311","doi-asserted-by":"crossref","first-page":"pp. 31","DOI":"10.1007\/978-3-319-30674-2_3","article-title":"\u201cISO 13482:2014 and its confusing categories. 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Devices (Auckl)"},{"key":"ref41","first-page":"pp. 92","year":"2020","journal-title":"\u201cEthical, legal and social issues in wearable robotics: Perspectives from the work of the COST Action on Wearable Robots,\u201d"},{"key":"ref101","article-title":"\u201cWhat do we need to build explainable AI systems for the medical domain?\u201d","volume":"vol. abs\/1712.09923","year":"2017","journal-title":"CoRR"},{"key":"ref161","doi-asserted-by":"crossref","first-page":"pp. 56","DOI":"10.4018\/IJEACH.2019070104","article-title":"\u201cA rule-based model for compliance of medical devices applied to the European market,\u201d","volume":"vol. 1","year":"2019","journal-title":"International Journal of Extreme Automation and Connectivity in Healthcare"},{"key":"ref571","doi-asserted-by":"crossref","first-page":"pp. 1418","DOI":"10.1016\/j.promfg.2015.07.306","article-title":"\u201cStandards for the safety of exoskeletons used by industrial workers performing manual handling activities: A 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11784","year":"2019"},{"key":"ref351","article-title":"\u201cPort clearance rules in PSOA RuleML: from controlled-English regulation to object-relational logic,\u201d","volume-title":"Proceedings of the RuleML + RR 2017 Challenge","volume":"vol. 1875","year":"2017"},{"key":"ref211","journal-title":"\u201cLegal and regulatory challenges for physical assistant robots,\u201d"},{"key":"ref771","year":"Apr 2018","journal-title":"Translators for interoperating and porting object-relational knowledge, PhD thesis"},{"key":"ref401","volume-title":"Wearable Exoskeleton Systems: Design, Control and Applications","year":"2018"},{"key":"ref111","volume-title":"FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results","year":"2018"},{"key":"ref711","article-title":"\u201cTwo paths for medical device approval: FDA vs. CE,\u201d","volume":"vol. 15","year":"2015","journal-title":"HealthManagemen"},{"key":"ref441","first-page":"pp. 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39","year":"2016"},{"key":"ref491","article-title":"\u201cWhat do we need to build explainable AI systems for the medical domain?\u201d","volume":"vol. abs\/1712.09923","year":"2017","journal-title":"CoRR"},{"key":"ref361","journal-title":"\u201cFormalizing Air Traffic Control Regulations in PSOA RuleML,\u201d"},{"key":"ref761","first-page":"pp. 52","article-title":"\u201cAligning, interoperating, and co-executing air traffic control rules across PSOA RuleML and IDP,\u201d","volume-title":"Rules and Reasoning, RuleML + RR 2019, Lecture Notes in Computer Science","volume":"vol. 11784","year":"2019"},{"key":"ref31","doi-asserted-by":"crossref","first-page":"pp. 19","DOI":"10.1109\/MRA.2017.2787222","article-title":"\u201cWearable robotics for motion assistance and rehabilitation [TC Spotlight],\u201d","volume":"vol. 25","year":"2018","journal-title":"IEEE Robotics Automation Magazine"},{"key":"ref481","first-page":"pp. 73","volume-title":"\u201cA formalization of HIPAA for a medical messaging system,\u201d","year":"2009"},{"key":"ref701","doi-asserted-by":"crossref","first-page":"pp. 31","DOI":"10.1007\/978-3-319-30674-2_3","article-title":"\u201cISO 13482:2014 and its confusing categories. 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Devices (Auckl)"},{"key":"ref131","article-title":"\u201cTowards realising wearable exoskeletons for elderly people,\u201d","volume-title":"Proceedings of the Advances in Robotics 2019, AIR 2019","year":"2019"},{"key":"ref261","first-page":"pp. 229","article-title":"\u201cLegal frame of non-social personal care robots,\u201d","volume-title":"New Trends in Medical and Service Robots, MESROB 2016, Mechanisms and Machine Science","volume":"vol. 48","year":"2018"},{"key":"ref231","doi-asserted-by":"crossref","first-page":"pp. 921","DOI":"10.1080\/17434440.2017.1407648","article-title":"\u201cOn the new regulation of medical devices in Europe,\u201d","volume":"vol. 14","year":"2017","journal-title":"Expert Review of Medical Devices"},{"key":"ref171","first-page":"pp. 203","article-title":"\u201cComputational regulation of medical devices in PSOA RuleML,\u201d","volume-title":"Rules and Reasoning, (Cham)","year":"2018"},{"key":"ref551","doi-asserted-by":"crossref","first-page":"pp. 56","DOI":"10.4018\/IJEACH.2019070104","article-title":"\u201cA rule-based model for compliance of medical devices applied to the European market,\u201d","volume":"vol. 1","year":"2019","journal-title":"International Journal of Extreme Automation and Connectivity in Healthcare"},{"key":"ref741","article-title":"\u201cPort clearance rules in PSOA RuleML: from controlled-English regulation to object-relational logic,\u201d","volume-title":"Proceedings of the RuleML + RR 2017 Challenge","volume":"vol. 1875","year":"2017"},{"key":"ref181","doi-asserted-by":"crossref","first-page":"pp. 1418","DOI":"10.1016\/j.promfg.2015.07.306","article-title":"\u201cStandards for the safety of exoskeletons used by industrial workers performing manual handling activities: A contribution from the Robo-Mate project to their future development,\u201d","volume":"vol. 3","year":"2015","journal-title":"Procedia Manufacturing"},{"key":"ref501","volume-title":"FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results","year":"2018"}],"container-title":["Paladyn, Journal of Behavioral Robotics"],"original-title":[],"link":[{"URL":"https:\/\/www.degruyter.com\/view\/journals\/pjbr\/11\/1\/article-p414.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/pjbr-2020-0026\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,22]],"date-time":"2021-04-22T04:01:23Z","timestamp":1619064083000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/pjbr-2020-0026\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,7]]},"references-count":62,"journal-issue":{"issue":"1"},"URL":"https:\/\/doi.org\/10.1515\/pjbr-2020-0026","relation":{},"ISSN":["2081-4836"],"issn-type":[{"value":"2081-4836","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,7]]}}}