scholarly journals ExosCE: A legal-based computational system for compliance with exoskeletons’ CE marking

2020 ◽  
Vol 11 (1) ◽  
pp. 414-427
Author(s):  
Sofia Almpani ◽  
Theodoros Mitsikas ◽  
Petros Stefaneas ◽  
Panayiotis Frangos
Keyword(s):  
Open Source ◽  
Medical Devices ◽  
Real Life ◽  
Conformity Assessment ◽  
Medical Applications ◽  
Computational System ◽  
Python Script ◽  
Wearable Robots ◽  
Assessment Procedures

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.

A Rule-Based Model for Compliance of Medical Devices Applied to the European Market

2019 ◽  
Vol 1 (2) ◽  
pp. 56-78 ◽  
Author(s):  
Sofia Almpani ◽  
Petros Stefaneas ◽  
Harold Boley ◽  
Theodoros Mitsikas ◽  
Panayiotis Frangos
Keyword(s):  
Knowledge Base ◽  
Open Source ◽  
Medical Devices ◽  
Feedback Loop ◽  
European Market ◽  
Conformity Assessment ◽  
Rule Based ◽  
Consumer Interest ◽  
Regulatory Frameworks

There is a growing producer and consumer interest in medical devices and the commensurate need for regulatory frameworks to ensure the quality of medical devices marketed locally and globally. This work focuses on formalizing the clauses enacted by Regulation (EU) 2017/745 for risk-based classification and class-based conformity assessment regarding marketability of medical devices. The resulting knowledge base (KB) represents clauses in Positional-Slotted Object-Applicative (PSOA) RuleML by integrating F-logic-like frames with Prolog-like relationships for atoms used as facts and in the conclusions and conditions of rules. Rules can apply polyadic functions, define polyadic relations, and augment conclusions with actions and conditions with events. The PSOA RuleML-implemented Medical Devices Rules KB was tested by querying in the open-source Java-implemented PSOATransRun system, which has provided a feedback loop for refinement and extension. This prototype can contribute to the licensing process of stakeholders and the registration of medical devices with a CE conformity mark.

scholarly journals Increasing the Quality of Agricultural Machinery Testing – A Comparison Between Italian and Polish Experience

2015 ◽  
Vol 6 (2) ◽  
pp. 14-24 ◽  
Author(s):  
Agnieszka Klembalska ◽  
Giulio Fancello
Keyword(s):  
Third Party ◽  
Conformity Assessment ◽  
Agricultural Machinery ◽  
Testing Laboratory ◽  
The Third ◽  
Polish Experience ◽  
The Third Party ◽  
Assessment Procedures ◽  
Protection Of Life

Abstract Safety of agricultural machinery is a key aspect in carrying out agrotechnical treatments. Appropriate testing of machines and equipment guarantees better protection of life or health. Applicable conformity assessment procedures do not require (except for particularly dangerous machines) participation of the third party - a professional, specialized, accredited, notified testing laboratory what raises a common fear of the dangers arising from ignorance of manufacturers.

Medical applications via minimal topological structure

2020 ◽  
Vol 39 (3) ◽  
pp. 4723-4730 ◽  
Author(s):  
A. A. Azzam ◽  
Ahmed Mostafa Khalil ◽  
Sheng-Gang Li
Keyword(s):  
Decision Making ◽  
Medical Information ◽  
Real Life ◽  
Medical Information System ◽  
Medical Applications ◽  
Qualitative Properties ◽  
Medical Problems ◽  
Life Problems ◽  
Minimal Structure

It is known that mathematical statics, mathematical modeling, and differential equations are used to give an in-depth understanding of many medical problems. On the edge of the information revolution, minimal structures show some qualitative properties issues that are difficult to deal with it, such as quality of education, nutrition, etc. The aim of this paper is to discuss two medical applications and show that a minimal structure space is suitable for analyzing several real-life problems. Then, the accuracy of the decision-making and attributes reduction of the medical information system are explained and obtained. Furthermore, we introduce a comparison between our approach and Pawlak’s approach to find accuracy for decision-making. Finally, the accuracy of decision-making via a variable precision model is improved.

Biological Evaluation of Medical Devices: A Review of EU Regulations, with Emphasis on In Vitro Screening for Biocompatibility

1995 ◽  
Vol 23 (4) ◽  
pp. 469-473
Author(s):  
Gottfried Schmalz
Keyword(s):  
Medical Devices ◽  
Quality Standards ◽  
Biological Evaluation ◽  
Conformity Assessment ◽  
European Economic Area ◽  
In Vitro Screening ◽  
European Economic ◽  
Economic Area

— The quality of medical devices (including their biocompatibility) is regulated throughout the European Economic Area by Directive 93/42/EEC, which came into effect on 1 January 1995. The CE (conformity assessment) mark placed on the device shows conformity with the essential requirements, which guarantee the desired level of quality. Standards can be used to prove this conformity with the essential requirements. Scientific input is needed to produce and update relevant standards.

Qualitative assessment of equipment failure cause finding and removal

2018 ◽  
pp. 116-126
Author(s):  
E. A. Vakulin ◽  
A. I. Zayats ◽  
V. A. Beklemeshev ◽  
V. A. Ivashkevich ◽  
V. A. Khazhiev ◽  
...  
Keyword(s):  
Production Condition ◽  
Real Life ◽  
Open Pit Mine ◽  
Qualitative Assessment ◽  
Open Pit ◽  
Quality Level ◽  
Equipment Failure ◽  
Operation Conditions ◽  
Failure Investigation

Investigation of failures is one of the critical activities of mining and haulage equipment operability assurance in mining. Maintaining failure investigation at the required quality level, it is possible to identify provisions, rules and procedures that should be revised or changed, operation conditions that should be improved, additional personnel training, if required, etc. Investigation of failures in mines is under responsibility of machine men and electricians of maintenance and operation services. In reality, factory management and setup for production condition weak concernment of these workers in quality investigation aimed at finding of sources of equipment failures. This article describes real-life results achieved in development and use of maintenance service operation, technology and management monitoring. The requirements are substantiated for quality improvement in failure cause finding and removal in mining and haulage equipment at Chernogorsky open pit mine, SUEK-Khakassia. Causes of the present quality of failure investigation by machine men of Chernogorsky Repair and Engineering Works and Chernogorsky open pit mine are revealed. The proposed recommended practices will improve quality of mining and haulage equipment failure investigation.

The Relationship between the Development of Human Capital and the Agricultural Economy in Rural Areas

2020 ◽  
pp. 61-65
Author(s):  
B.A. Voronin ◽  
◽  
I.P. Chupina ◽  
Ya.V. Voronina ◽  
◽  
...  
Keyword(s):  
Human Capital ◽  
Rural Areas ◽  
Agricultural Production ◽  
Agricultural Sector ◽  
Real Life ◽  
Standard View ◽  
Household Factors ◽  
Economic Transformations ◽  
The Relationship

The article discusses a non-standard view of the formation of human capital for work in organizations of the agricultural sector of the economy, in the context of modern socio-economic transformations. In the classical sense, human capital for agriculture should be formed and developed in rural areas. But in real life, this is not always the case, because there are many factors that prevent the classical solution of this problem. First, the demographic factor affects, second, social and household factors, and third, in many rural areas there are no working agricultural organizations where qualified agricultural specialists can work. All these and other circumstances actualize the problem of the quality of human capital in rural areas in relation to the development of agricultural production.

PyDOSS: An open-source Python-based communicable disease outbreak surveillance system designed and used in a COVID-19 community care facility (Preprint)

2020 ◽  
Author(s):  
Andrew Fang ◽  
Jonathan Kia-Sheng Phua ◽  
Terrence Chiew ◽  
Daniel De-Liang Loh ◽  
Lincoln Ming Han Liow ◽  
...  
Keyword(s):  
Open Source ◽  
Surveillance System ◽  
Community Care ◽  
Communicable Disease ◽  
Low Cost ◽  
Real Life ◽  
Disease Outbreak ◽  
Disease Spread ◽  
Healthcare Team ◽  
Increased Risk

BACKGROUND During the Coronavirus Disease 2019 (COVID-19) outbreak, community care facilities (CCF) were set up as temporary out-of-hospital isolation facilities to contain the surge of cases in Singapore. Confined living spaces within CCFs posed an increased risk of communicable disease spread among residents. OBJECTIVE This inspired our healthcare team managing a CCF operation to design a low-cost communicable disease outbreak surveillance system (CDOSS). METHODS Our CDOSS was designed with the following considerations: (1) comprehensiveness, (2) efficiency through passive reconnoitering from electronic medical record (EMR) data, (3) ability to provide spatiotemporal insights, (4) low-cost and (5) ease of use. We used Python to develop a lightweight application – Python-based Communicable Disease Outbreak Surveillance System (PyDOSS) – that was able perform syndromic surveillance and fever monitoring. With minimal user actions, its data pipeline would generate daily control charts and geospatial heat maps of cases from raw EMR data and logged vital signs. PyDOSS was successfully implemented as part of our CCF workflow. We also simulated a gastroenteritis (GE) outbreak to test the effectiveness of the system. RESULTS PyDOSS was used throughout the entire duration of operation; the output was reviewed daily by senior management. No disease outbreaks were identified during our medical operation. In the simulated GE outbreak, PyDOSS was able to effectively detect an outbreak within 24 hours and provided information about cluster progression which could aid in contact tracing. The code for a stock version of PyDOSS has been made publicly available. CONCLUSIONS PyDOSS is an effective surveillance system which was successfully implemented in a real-life medical operation. With the system developed using open-source technology and the code made freely available, it significantly reduces the cost of developing and operating CDOSS and may be useful for similar temporary medical operations, or in resource-limited settings.

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