Functional Safety Certification for Surgical Robots: IEC 80601-2-78 Explained

Date
2027-07-06
Location
Online
Host
Zach L

About this event

A Refresher Course for Regulatory Affairs Specialists pursuing functional safety certification. A live 30-minute refresher course on IEC 80601-2-78 (Rehabilitation Robot Safety) for surgical robots, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What IEC 80601-2-78 (Rehabilitation Robot Safety) requires and how its scope applies to surgical robots Mapping IEC 80601-2-78 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of surgical robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for regulatory affairs specialists preparing for assessment Related topics: IEC 80601-2-78 · Surgical Robots · functional safety certification · functio

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About IEC 80601-2-78 (Rehabilitation Robot Safety)

This training provides practical skills and structured learning on the compliance requirements covered by IEC 80601-2-78.

IEC 80601-2-78 covers medical robots for rehabilitation, assessment, compensation or alleviation — exoskeletons and therapy robots physically attached to impaired users — with particular requirements over 60601-1.

What it regulates

Actuated-attachment hazards: excessive force/range on impaired limbs, misalignment, fall interaction, emergency release, and essential performance of motion therapy under fault.

Who must comply

Medical exoskeleton and therapy robot manufacturers (distinct from 13482's non-medical assistive scope).

Key requirements of IEC 80601-2-78

  • RACA (rehab/assessment/compensation/alleviation) robot scope
  • Limits and monitoring for forces/torques on body segments
  • Attachment/release and fall-related behavior
  • Patient-specific configuration safety

Key concepts: IEC 80601-2-78

Attached-user hazard model
The user cannot simply step away — release and compliance behavior are safety functions.
Physiological limits
Person-specific joint range/force constraints enforced by the device.
RACA robot
The defined medical rehabilitation robot category.

Frequently asked questions: IEC 80601-2-78

Exoskeleton: 13482 or 80601-2-78?

Medical purpose (therapy/compensation for impairment) → medical framework with 80601-2-78; non-medical assistance (industrial support, able-bodied augmentation) → ISO 13482 under machinery rules. Intended use decides the regime.

Standard information based on the published text of IEC 80601-2-78 (Rehabilitation Robot Safety). Event content is provided by the host. For authoritative guidance, consult the official standard body.