Functional Safety Certification for Surgical Robots: IEC 61326-3-1 Explained

Date
2026-09-10
Location
Online
Host
Zach L

About this event

A Live Webinar for Cross-Functional Product Teams pursuing functional safety certification. A live 30-minute live webinar on IEC 61326-3-1 (EMC for Safety-Related Systems) for surgical robots, built for cross-functional product teams pursuing functional safety certification. What We'll Cover: What IEC 61326-3-1 (EMC for Safety-Related Systems) requires and how its scope applies to surgical robots Mapping IEC 61326-3-1 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 cross-functional product teams preparing for assessment Related topics: IEC 61326-3-1 · Surgical Robots · functional safety certification · functional sa

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About IEC 61326-3-1 (EMC for Safety-Related Systems)

This online session delivers expert-led instruction on the regulatory landscape and implementation approach for IEC 61326-3-1.

IEC 61326-3-1 specifies electromagnetic immunity requirements for equipment performing safety-related functions per IEC 61508, defining increased immunity test levels and pass criteria so that electromagnetic disturbances do not cause dangerous failures.

What it regulates

EMC immunity testing and performance criteria for safety-related measurement, control and laboratory equipment intended for general industrial electromagnetic environments.

Who must comply

Manufacturers of safety-related sensors, transmitters, controllers and drives claiming SIL capability, as part of demonstrating sufficient immunity against systematic environmental influences.

Key requirements of IEC 61326-3-1

  • Immunity test levels above basic industrial requirements for phenomena such as ESD, radiated RF, EFT/burst, surge, conducted RF, and power interruptions
  • Definition of performance criterion FS: the safety function must be maintained or the equipment must enter/maintain a defined safe state during and after disturbance
  • Requirements for defining the safety state and monitoring during tests

Key concepts: IEC 61326-3-1

Increased immunity levels
Test levels deliberately set above standard industrial EMC to provide margin for safety functions.
Performance criterion FS
The pass criterion requiring that during disturbance the equipment either continues its safety function or transitions to and holds the specified safe state.
Safe state under disturbance
The predefined output condition the equipment must assume if the disturbance prevents normal operation.
Systematic failure from EMI
Electromagnetic interference treated as a systematic influence that must be controlled for SIL claims.

Frequently asked questions: IEC 61326-3-1

Why is standard CE-mark EMC testing not enough for safety functions?

Basic EMC standards allow temporary degradation during disturbance. For safety functions, degradation could be a dangerous failure, so 61326-3-1 applies higher levels and the strict FS criterion tied to a defined safe state.

Is IEC 61326-3-1 required for every SIL-rated device?

IEC 61508-2 requires control of environmental and EMC influences; testing per 61326-3-1 (or 3-2 for specified environments) is the accepted way to evidence immunity for most industrial safety devices.

Standard information based on the published text of IEC 61326-3-1 (EMC for Safety-Related Systems). Event content is provided by the host. For authoritative guidance, consult the official standard body.