Functional Safety Certification for Machine-Tending Robots: ISO 10218-2 Explained

Date: 2027-07-15
Location: Online
Host: Zach L

About this event

A Certification-Prep Session for Regulatory Affairs Specialists pursuing functional safety certification. A live 30-minute certification-prep session on ISO 10218-2 (Robot Systems and Integration) for machine-tending robots, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What ISO 10218-2 (Robot Systems and Integration) requires and how its scope applies to machine-tending robots Mapping ISO 10218-2 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of machine-tending robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for regulatory affairs specialists preparing for assessment Related topics: ISO 10218-2 · Machine-Tending Robots · functional safety certification · functional safety assessment · Certification-Prep Session · Regulatory Affairs Specialists · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for ISO 10218-2. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About ISO 10218-2 (Robot Systems and Integration)

This training provides practical skills and structured learning on the compliance requirements covered by ISO 10218-2.

ISO 10218-2:2025 covers the robot system and cell: integration of robots with end-effectors, workpieces, safeguarding and other machinery — layout, safeguarded and restricted spaces, collaborative applications, and system verification/validation.

What it regulates

Cell risk assessment, safeguarded space design, perimeter and interior safeguarding, collaborative application requirements (methods formerly in TS 15066), modes of operation, and the integrator's validation obligations.

Who must comply

System integrators and end users assembling robot cells — the CE (or US risk assessment) responsibility for the application sits here.

Key requirements of ISO 10218-2

Restricted vs safeguarded space definition and limiting devices

Safeguarding selection: guards, ESPE, scanners, and functional safety of the integration

Collaborative applications: SMS, HG, SSM, PFL and their combined use

Cell modes, reset/restart philosophy, and entrapment/escape considerations

Verification and validation checklist for the integrated system

Key concepts: ISO 10218-2

Application validation

Measurements (stopping distances, forces for PFL) proving the implemented cell meets its assessed limits.

PFL (Power and Force Limiting)

Collaborative method bounding contact forces/pressures to biomechanical limits.

Safeguarded space

The volume protected by perimeter and interior safeguards where hazards are controlled.

SSM (Speed and Separation Monitoring)

Collaborative method maintaining a protective separation distance via scanners/vision with speed scaling.

Frequently asked questions: ISO 10218-2

Who signs the conformity for a robot cell in the EU?

The integrator (or end user acting as one) performs the cell risk assessment and conformity procedure under the Machinery Regulation — the robot's own certification does not transfer to the application.

Are cobot applications exempt from guarding?

No — 'collaborative' describes the application method, not the robot. PFL applications still require force/pressure validation against biomechanical limits, and SSM applications need certified detection with computed separation distances; many cobot cells still need partial guarding for the process hazards.