Computational Regulation of Medical Devices in PSOA RuleML

机译：PSOA ruleml中医疗器械的计算调节

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The registration and marketability of medical devices in Europe is governed by the Regulation (EU) 2017/745 and by guidelines published in terms thereof. This work focuses on formalizing the rules for risk-based classification of medical devices as well as the conformity assessment options for each class in Positional-Slotted Object-Applicative (PSOA) RuleML. We tested this open-source knowledge base by querying it in the open-source PSOATransRun system. The aim of this formalization is to create a computational guideline to assist stakeholders.

机译：欧洲医疗设备的登记和可销售性受到2017/745条例（欧盟）的管辖，并通过其提出的指导方针。这项工作侧重于正式确定医疗器械的风险分类规则以及定位的物体申请（PSOA）Ruleml中每个类的符合性评估选项。我们通过在开源PsoatransRun系统中查询它来测试此开源知识库。该形式化的目的是创建一个计算指南，以帮助利益攸关方。

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《International Joint Conference on Rules and Reasoning》|2018年|xxiii 328 p.|共8页
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Sofia Almpani; Petros Stefaneas; Harold Boley; Theodoros Mitsikas; Panayiotis Frangos;
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中图分类计算机网络;
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1. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [J] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, German Medical Science . 2021,第a期

机译：AWMF AD HOC委员会在体外诊断医疗器械上制造和仅根据监管（欧盟）2017/746（IVDR）在联盟建立的卫生机构内使用的体外诊断医疗器械的咨询意见
2. The medical devices regulation in the EU - the evolution of the regulatory framework for medical devices [J] . Brigitte Casteels Sebastian Rohde Pharmaceuticals policy and law. . 2013,第1a2期

机译：欧盟医疗器械法规-医疗器械法规框架的演变
3. The regulation of medical devices and the role of the Medical Devices Agency. [J] . Jefferys DB British Journal of Clinical Pharmacology . 2001,第3期

机译：医疗器械的法规和医疗器械局的角色。
4. Computational Regulation of Medical Devices in PSOA RuleML [C] . Sofia Almpani, Petros Stefaneas, Harold Boley, International joint conference on rules and reasoning . 2018

机译：PSOA RuleML中医疗器械的计算规则
5. The Use of Predicates in FDA Regulation of Medical Devices: A Case Study of Robotic Surgical Devices [D] . Lefkovich, Charlotte. 2018

机译：医疗器械FDA调节谓词的使用 - 以机器人外科手术装置为例
6. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [O] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, 2021

机译：AWMF临时委员会在体外诊断医疗器械的咨询意见这些医疗器械均仅在工会中建立的卫生机构内根据条例（欧盟）2017/746（IVDR）
7. Changes in the Medical Device’s Regulatory Framework and Its Impact on the Medical Device’s Industry: From the Medical Device Directives to the Medical Device Regulations [O] . Magali Contardi 2019

机译：医疗设备监管框架的变化及其对医疗器械行业的影响：从医疗器械指令到医疗器械规定

Computational Regulation of Medical Devices in PSOA RuleML

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