We propose the Riskman ontology and shapes for representing and analysing information about risk management for medical devices. Risk management is concerned with taking necessary precautions to ensure that a medical device does not cause harms for users or the environment. To date, risk management documentation is submitted to notified bodies (for certification) in the form of semi-structured natural language text. We propose to use terms from the Riskman ontology to provide a formal, logical underpinning for risk management documentation, and to use the included SHACL constraints to check whether the provided data is in accordance with the requirements of the two relevant norms, i.e. ISO 14971 and VDE Spec 90025.

翻译：我们提出了Riskman本体与形状，用于表示和分析医疗器械风险管理相关信息。风险管理旨在采取必要预防措施，确保医疗器械不会对用户或环境造成危害。目前，风险管理文档以半结构化自然语言文本形式提交给公告机构（用于认证）。我们建议使用Riskman本体的术语为风险管理文档提供形式化的逻辑基础，并利用其包含的SHACL约束来检查所提供数据是否符合两项相关规范（即ISO 14971和VDE Spec 90025）的要求。