Functional Safety Certification for Pharmacy Automation Robots: IEC 62061 Explained

Date
2027-07-27
Location
Online
Host
Zach L

About this event

A Worked-Examples Session for Risk Assessors pursuing functional safety certification. A live 30-minute worked-examples session on IEC 62061 (Safety of Machinery - SIL) for pharmacy automation robots, built for risk assessors pursuing functional safety certification. What We'll Cover: What IEC 62061 (Safety of Machinery - SIL) requires and how its scope applies to pharmacy automation robots Mapping IEC 62061 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: IEC 62061 · Pharmacy Automation Robots · functional safety certification · functional safety ass

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About IEC 62061 (Safety of Machinery - SIL)

This event covers the compliance, engineering, and verification requirements defined by IEC 62061.

IEC 62061 is the machinery-sector implementation of IEC 61508 for safety-related control systems, expressing integrity as SIL 1-3, with the 2021 edition broadened to all technologies and aligned terminology with ISO 13849.

What it regulates

SIL assignment for machinery safety functions, subsystem design with architectural constraints, systematic capability, software requirements, and information for use of SIL-rated subsystems.

Who must comply

Machine builders preferring the SIL framework, especially with complex programmable architectures; suppliers stating SIL claim limits for machinery subsystems.

Key requirements of IEC 62061

  • Risk-based SIL assignment methodology
  • Subsystem architectures with basic subsystem architectures A-D
  • PFHd calculation combining subsystem contributions
  • Requirements for software (per 61508-3 principles scaled to machinery)
  • 2021 alignment: shared terms with ISO 13849, both routes harmonized under the Machinery framework

Key concepts: IEC 62061

SIL CL (claim limit)
The maximum SIL a subsystem can support in a machinery safety function.
Architectures A-D
Reference structures (from single channel no diagnostics to dual channel with diagnostics) with formulas for dangerous failure probability.
PFHd
Probability of dangerous failure per hour — the quantity summed across subsystems and compared to SIL bands.
Systematic capability
As in 61508, the qualitative design rigor accompanying the numbers.

Frequently asked questions: IEC 62061

IEC 62061 or ISO 13849 — must I pick one?

Yes, per safety function: both are harmonized, and the 2021 editions are aligned so results correspond (SIL 1≈PL c, SIL 2≈PL d, SIL 3≈PL e). Mixing frameworks inside one function's claim is not accepted.

What changed in the 2021 edition?

Scope extended beyond electrical technology, terminology aligned with ISO 13849 (subsystems, elements), updated architectural formulas and software clauses — easing combined use of components specified under either standard.

Standard information based on the published text of IEC 62061 (Safety of Machinery - SIL). Event content is provided by the host. For authoritative guidance, consult the official standard body.