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 「適用於製造廠之醫療器材網路安全指引」 【發布日期：2019-11-21】 |
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依據：行政程序法165條
公告事項：
一、公告「適用於製造廠之醫療器材網路安全指引（如附件），以提供廠商作為產品研發、申請查驗登記資料準備及產品核准上市後應考量之網路安全相關要點之參考。
二、本案另載於本署全球資訊網站（www.fda.gov.tw）之公告區及醫療器材法規專區。
- US FDA: Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, 2005. 網體安全性(網路犯罪與惡意攻擊)
- US FDA: Guidance for Industry and FDA Staff: Content of Premarket submissions for Management of Cybersecurity in Medical Devices, 2014.
- US FDA: Guidance for Industry and FDA Staff: Postmarket Management of Cybersecurity in Medical Device, 2016
- US FDA: Guidance for Industry and FDA Staff: Design Considerations and Premarket Submission Recommendations for Interoperable Medical Device, 2017.
- US FDA: Guidance for Industry and FDA Staff: Deciding When to Submit a 510(k) for a Software Change to an Existing Device, 2017.
- US FDA: Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, 2005.
- ISO 14971:2007, Medical devices - Application of risk management to medical devices
- IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-2: Guidance for the communication of medical device security needs, risks and controls. 醫療器械資訊安全需求、風險和控制的溝通指南。
- ANSI/AAMI TIR57:2016, Principles for medical device security-Risk management
- UL 2900-1:2017, Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements 網體安全性
- UL 2900-2-1:2017, Software Cybersecurity for Network-Connectable Products, Part 15 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
- HIMSS/NEMA Standard HN 1-2013, Manufacturer Disclosure Statement for Medical Device Security form (MDS2