標準簡介
IEC 62366-1:2015+AMD1:2020 是由 國際電工委員會 (IEC) 發布的現行有效標準，常用於醫療器材、醫療健康、電子產品等產業，並適用於全球等市場。
本頁整理了 IEC 62366-1:2015+AMD1:2020 的官方文件、目前狀態以及常見相關認證或評估機構，便於快速理解要求與落地路徑。
Use Error Prevention
Focuses on identifying and mitigating use errors that could lead to harm — not user convenience, but safety-critical interactions between users and the medical device user interface.
User-Centered Process
Requires manufacturers to understand users, use environments, and user interface characteristics through structured analysis, including contextual inquiry and user profiles.
Summative Evaluation
Mandates summative (validation) usability testing with representative users performing critical tasks to provide objective evidence that the device can be used safely.
list_alt Usability Engineering Process
- Use specification and user profile definition
- Identification of user interface characteristics related to safety
- Identification of known or foreseeable hazards and hazardous situations
- Identification of hazard-related use scenarios
- Formative evaluation (iterative design testing)
- Summative evaluation (validation testing)
- Documentation in usability engineering file
- Integration with ISO 14971 risk management process
Who Needs to Comply?
All medical device manufacturers, including software-as-a-medical-device (SaMD) developers. Required by the EU MDR, recognized by the FDA as a consensus standard, and referenced globally for regulatory submissions.
Key Requirements
Use Specification
Define the intended users, intended use environments, and user interface characteristics of the medical device. Establish a use specification document that drives all subsequent usability activities.
Hazard-Related Use Scenarios
Identify use scenarios where foreseeable use errors or correct use could lead to hazardous situations. Analyze the user interface to determine which tasks are safety-critical and require focused usability engineering.
Formative Evaluation
Conduct iterative formative evaluations during design and development to identify usability issues early. Methods include cognitive walkthroughs, heuristic evaluations, expert reviews, and user testing with prototypes.
Summative Evaluation
Perform summative (validation) usability testing with representative users in simulated or actual use environments. Demonstrate that users can perform critical tasks safely and that residual use-related risks are acceptable.
Usability Engineering File
Maintain a usability engineering file documenting the entire process — use specification, hazard analysis, formative and summative evaluations, and evidence that use-related risks have been adequately addressed.
Penalties & Enforcement
No direct fines for non-compliance. However, inadequate usability engineering can lead to rejection of regulatory submissions (FDA 510(k)/PMA, EU MDR Technical Documentation), product recalls due to use errors, and liability exposure from patient harm caused by design-related use errors.