Functional Safety Certification for Pharmacy Automation Robots: ISO 10218-2 Explained

Date
2027-04-16
Location
Online
Host
Zach L

About this event

A Lunch-and-Learn for Quality Engineers pursuing functional safety certification. A live 30-minute lunch-and-learn on ISO 10218-2 (Robot Systems and Integration) for pharmacy automation robots, built for quality engineers pursuing functional safety certification. What We'll Cover: What ISO 10218-2 (Robot Systems and Integration) requires and how its scope applies to pharmacy automation robots Mapping ISO 10218-2 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of pharmacy automation robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for quality engineers preparing for assessment Related topics: ISO 10218-2 · Pharmacy Automation Robots · functional safety certification · functional s

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About ISO 10218-2 (Robot Systems and Integration)

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

Standard information based on the published text of ISO 10218-2 (Robot Systems and Integration). Event content is provided by the host. For authoritative guidance, consult the official standard body.