Functional Safety Certification for Surgical Robots: IEC TR 63069 Explained

Date
2026-09-18
Location
Online
Host
Zach L

About this event

A Certification-Prep Session for Embedded Systems Engineers pursuing functional safety certification. A live 30-minute certification-prep session on IEC TR 63069 (Safety and Security Convergence) for surgical robots, built for embedded systems engineers pursuing functional safety certification. What We'll Cover: What IEC TR 63069 (Safety and Security Convergence) requires and how its scope applies to surgical robots Mapping IEC TR 63069 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 embedded systems engineers preparing for assessment Related topics: IEC TR 63069 · Surgical Robots · functional safety certification · functional safety assessment · Certification-Prep Session · Embedded Systems Engineers · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for IEC TR 63069. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About IEC TR 63069 (Safety and Security Convergence)

This training provides practical skills and structured learning on the compliance requirements covered by IEC TR 63069.

IEC TR 63069 provides guidance on applying IEC 61508 functional safety and IEC 62443 cybersecurity together in industrial automation, resolving lifecycle interactions so that neither discipline undermines the other.

What it regulates

Coordination principles: protecting safety functions within secure zones, managing conflicting requirements, and coordinating risk assessments and incident response across safety and security teams.

Who must comply

Organizations running both safety and security programs for IACS — asset owners, integrators, and suppliers aligning SIL-rated systems with 62443 zones and conduits.

Key requirements of IEC TR 63069

  • Framework mapping the safety lifecycle to the security lifecycle
  • Guiding principles including protection of safety implementations by security countermeasures
  • Guidance on co-engineering, roles, and communication between disciplines
  • Treatment of security-relevant events as potential initiators of hazardous events

Key concepts: IEC TR 63069

Security environment for safety
The concept that every safety function must operate inside an adequately secured zone.
Co-engineering
Joint, coordinated engineering of safety and security requirements rather than sequential or siloed treatment.
Conflict resolution
Structured handling of cases where a security measure (like lockout after failed logins) could impede a safety action, and vice versa.
Threat-risk vs hazard-risk assessment
Parallel assessments whose results must be reconciled because attacks can trigger hazards.

Frequently asked questions: IEC TR 63069

Can a cyber attack invalidate a SIL rating?

Effectively yes: SIL calculations assume failure behavior that a deliberate attack can bypass. That is why 63069 requires safety systems to sit within zones whose security level is chosen considering the safety impact of compromise.

Is IEC TR 63069 certifiable?

It is a Technical Report giving guidance, not a certifiable requirements standard; conformity claims remain against IEC 61508 and IEC 62443, with 63069 shaping how the two programs interlock.

Standard information based on the published text of IEC TR 63069 (Safety and Security Convergence). Event content is provided by the host. For authoritative guidance, consult the official standard body.