Functional Safety Certification for Pharmacy Automation Robots: ISO 10218-1 Explained

Date
2027-06-21
Location
Online
Host
Zach L

About this event

A Compliance Clinic for Risk Assessors pursuing functional safety certification. A live 30-minute compliance clinic on ISO 10218-1 (Robot Safety Requirements) for pharmacy automation robots, built for risk assessors pursuing functional safety certification. What We'll Cover: What ISO 10218-1 (Robot Safety Requirements) requires and how its scope applies to pharmacy automation robots Mapping ISO 10218-1 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 risk assessors preparing for assessment Related topics: ISO 10218-1 · Pharmacy Automation Robots · functional safety certification · functional safety assessm

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About ISO 10218-1 (Robot Safety Requirements)

This event covers the compliance, engineering, and verification requirements defined by ISO 10218-1.

ISO 10218-1:2025 specifies safety requirements for the industrial robot itself — the manipulator and controller as supplied — including protective stop functions, speed control, axis limiting, and the functional safety performance of these capabilities.

What it regulates

Inherent robot design measures, required safety functions (emergency stop, protective stop, reduced speed 250 mm/s in manual modes, safety-rated soft axis and space limiting), functional safety requirements for those functions, and collaborative-capability building blocks absorbed from ISO/TS 15066.

Who must comply

Robot manufacturers worldwide — 10218-1 is the certification basis for industrial robot arms and controllers.

Key requirements of ISO 10218-1

  • Robot stop functions and categories
  • Manual mode requirements: reduced speed, enabling device, hold-to-run
  • Safety-rated soft limits and monitored spaces
  • Functional safety requirements (PL/SIL) for robot safety functions
  • 2025 revision: classes of robots and integrated collaborative requirements

Key concepts: ISO 10218-1

Safety-rated soft axis/space limiting
Certified software limits replacing mechanical stops to bound the restricted space.
Enabling device
The three-position deadman on the pendant permitting motion only in the center position.
Protective stop
A monitored stop initiated by safeguarding, from which automatic resumption is permitted when conditions clear (unlike e-stop).
Reduced speed
The 250 mm/s TCP cap in manual mode enabling teach operations with a person nearby.

Frequently asked questions: ISO 10218-1

What changed in the 2025 edition?

The 2021-cycle revision published in 2025 integrates collaborative requirements (retiring ISO/TS 15066 as a separate document), introduces robot classes with proportionate functional safety expectations, and details cybersecurity-relevant considerations for safety functions.

Does a certified robot make my robot cell safe?

No — 10218-1 covers the robot as a component; the application, layout, safeguarding, and system-level validation are the integrator's job under ISO 10218-2. Most robot accidents trace to integration, not the arm.

Standard information based on the published text of ISO 10218-1 (Robot Safety Requirements). Event content is provided by the host. For authoritative guidance, consult the official standard body.