Sources — Medical Robotics Reference

This reference is grounded in internationally recognized standards and regulatory documents defining robotics terminology, medical device governance, and clinical system boundaries across major regulatory regions.

Sources reflect a global perspective, including international standards and region-specific regulatory frameworks in Europe, North America, and Asia. Only stable, directly accessible documents are listed.

International Standards

European Union (Regulatory Framework)

United States (Regulatory Framework)

Asia (Japan — Regulatory Framework)

Purpose of Sources

These sources provide the formal reference framework for terminology, safety, and regulatory classification in medical robotics across jurisdictions. They are used as structural anchors and do not represent clinical guidance or approval claims.