Functional Safety Certification for Surgical Robots: IEC 62443 Explained

Date: 2026-10-08
Location: Online
Host: Zach L

About this event

A Guided Tutorial for Commissioning Engineers pursuing functional safety certification. A live 30-minute guided tutorial on IEC 62443 (Industrial Cybersecurity) for surgical robots, built for commissioning engineers pursuing functional safety certification. What We'll Cover: What IEC 62443 (Industrial Cybersecurity) requires and how its scope applies to surgical robots Mapping IEC 62443 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 commissioning engineers preparing for assessment Related topics: IEC 62443 · Surgical Robots · functional safety certification · functional safety assessment · Guided Tutorial · Commissioning Engineers · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for IEC 62443. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About IEC 62443 (Industrial Cybersecurity)

This event covers the compliance, engineering, and verification requirements defined by IEC 62443.

IEC 62443 is the leading standard series for cybersecurity of industrial automation and control systems (IACS). It addresses secure system architecture, security levels, component development, and the responsibilities of asset owners, integrators, and product suppliers across the plant lifecycle.

What it regulates

Security programs, secure development lifecycles, zone-and-conduit architectures, and technical security capabilities of components and systems in operational technology environments.

Who must comply

Asset owners operating industrial facilities, system integrators building control systems, and product suppliers of controllers, network gear, and software used in OT environments; increasingly referenced by regulation and by customers as a procurement requirement.

Key requirements of IEC 62443

62443-1-x: Concepts, terminology and metrics

62443-2-1: Security program requirements for asset owners

62443-2-4: Security requirements for service providers

62443-3-2: Risk assessment and system partitioning into zones and conduits

62443-3-3: System security requirements and Security Levels (SL 1-4)

62443-4-1: Secure product development lifecycle (SDL)

62443-4-2: Technical security requirements for components

Key concepts: IEC 62443

Security PHA / cyber risk assessment

The 62443-3-2 process of assessing cyber risk to determine target security levels for each zone and conduit.

Defense in depth

Layered, complementary security measures so that compromise of one layer does not defeat the system.

Foundational Requirements (FR1-FR7)

The seven requirement families — identification and authentication, use control, system integrity, data confidentiality, restricted data flow, timely response to events, and resource availability.

Security Level (SL 1-4)

Graded protection targets against increasingly capable attackers, from casual violation (SL 1) to sophisticated, well-resourced adversaries (SL 4).

Zones and conduits

The partitioning of a system into groupings of assets with common security requirements (zones) connected by controlled communication channels (conduits).

Frequently asked questions: IEC 62443

How does IEC 62443 relate to functional safety standards?

Safety and security are complementary: a cyber attack can defeat a safety function. IEC TR 63069 gives guidance on aligning IEC 61508-based safety with 62443-based security, including protecting safety instrumented systems within appropriately secured zones.

Can a component be certified to IEC 62443?

Yes — component suppliers certify products against 62443-4-2 with development processes per 62443-4-1; schemes such as ISASecure operate accredited certification programs.

What is the difference between SL-T, SL-A and SL-C?

SL-T is the target level from risk assessment, SL-C is the capability a component or system can provide when properly configured, and SL-A is the level actually achieved in the deployed installation.