Functional Safety Certification for Pharmacy Automation Robots: IEC 62998 Explained

Date
2026-10-23
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 IEC 62998 (Safety-Related Sensors) for pharmacy automation robots, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What IEC 62998 (Safety-Related Sensors) requires and how its scope applies to pharmacy automation robots Mapping IEC 62998 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 regulatory affairs specialists preparing for assessment Related topics: IEC 62998 · Pharmacy Automation Robots · functio

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About IEC 62998 (Safety-Related Sensors)

This training provides practical skills and structured learning on the compliance requirements covered by IEC 62998.

IEC TS 62998-1 addresses safety-related sensors used for detection of persons and objects — including technologies and sensor fusion beyond classical ESPE — providing requirements for performance definition, environmental influence, and integration when standard device norms do not fit.

What it regulates

Specification of detection capability and dependability for individual sensors and sensor systems (including fusion), safety-related performance under environmental conditions, and the interface between sensor claims and machine-level risk reduction.

Who must comply

Developers of novel detection sensors (3D ToF, radar, lidar, vision) for safety functions, integrators using such sensors in mobile robots, AGVs, and off-highway machinery.

Key requirements of IEC 62998

  • Sensor and sensor-system classification and safety-related performance characteristics
  • Requirements for combining sensors (fusion) to reach a claimed integrity
  • Environmental and application condition declaration (light, weather, surfaces, mounting)
  • Guidance where IEC 61496 device standards do not cover the technology (3D vision, radar, lidar)

Key concepts: IEC 62998

Environmental robustness declaration
Explicit statement of the conditions under which the safety performance holds.
Sensor fusion for safety
Combining diverse sensing channels so that the fused claim meets integrity targets individual sensors cannot.
Technology-neutral ESPE gap
62998 covers technologies (like outdoor lidar or radar) for which no IEC 61496-series product standard exists.
Detection capability
The declared object size, reflectivity, speed and position envelope the sensor reliably detects.

Frequently asked questions: IEC 62998

When do I need 62998 instead of IEC 61496?

IEC 61496 parts cover established ESPE technologies (light curtains, laser scanners, vision-based protective devices per part). For technologies or fusion architectures outside those parts — outdoor navigation lidar, radar person detection — IEC TS 62998 provides the framework to specify and evidence safety performance.

Can a 62998 sensor claim a PL or SIL?

The sensor system's dependability evidence feeds a PL/SIL claim for the detection function; integrators must combine the declared detection capability and environmental limits with control-side integrity (13849/62061) for the complete safety function.

Standard information based on the published text of IEC 62998 (Safety-Related Sensors). Event content is provided by the host. For authoritative guidance, consult the official standard body.