Functional Safety Certification for Pharmacy Automation Robots: ISO 13849-2 Explained

Date
2027-04-12
Location
Online
Host
Zach L

About this event

A Guided Tutorial for Automation Engineers pursuing functional safety certification. A live 30-minute guided tutorial on ISO 13849-2 (Validation) for pharmacy automation robots, built for automation engineers pursuing functional safety certification. What We'll Cover: What ISO 13849-2 (Validation) requires and how its scope applies to pharmacy automation robots Mapping ISO 13849-2 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 automation engineers preparing for assessment Related topics: ISO 13849-2 · Pharmacy Automation Robots · functional safety certification · functional safety assessment · Guided Tut

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About ISO 13849-2 (Validation)

This event covers the compliance, engineering, and verification requirements defined by ISO 13849-2.

EN ISO 13849-2 defines validation of safety-related control parts against Part 1: confirming by analysis and testing that each SRP/CS meets its specified PL, Category, and functional requirements, including the fault lists and basic/well-tried safety principles per technology.

What it regulates

Validation planning, fault lists and fault exclusions for mechanical, pneumatic, hydraulic and electrical technologies, verification of category behavior under fault injection, and confirmation of environmental robustness.

Who must comply

Machine builders validating their safety functions before first use or market placement, and suppliers evidencing category behavior of subsystems.

Key requirements of ISO 13849-2

  • Validation plan covering analysis, inspection, and testing
  • Technology annexes with component fault lists and permitted fault exclusions
  • Basic and well-tried safety principles and well-tried components criteria
  • Fault injection demonstrating category-required behavior (single fault, fault accumulation)
  • Validation of software and parameterization

Key concepts: ISO 13849-2

Validation vs verification
Verification checks design outputs against requirements at each step; validation confirms the final SRP/CS fulfills its overall safety requirements.
Fault exclusion
A justified, documented decision that a specific fault need not be considered (for example shorting of a properly dimensioned, protected conductor), used sparingly and per the annex criteria.
Fault injection test
Deliberate introduction of listed faults to confirm the SRP/CS reacts per its category (detection, safe state).
Well-tried component
A component with a long, documented history of safe use in similar applications, or made and verified to relevant standards, permitted in Category 1.

Frequently asked questions: ISO 13849-2

What evidence does validation produce?

A validation report tying each safety function to its PLr, showing analysis results, executed fault-injection and functional tests with outcomes, environmental testing references, and closure of all deviations.

Are fault exclusions allowed at PL e?

They are heavily restricted: exclusions for certain mechanical failures (like the direct opening action of a positively driven contact) can be maintained, but electrical fault exclusions become hard to justify at the highest levels and must be explicitly documented with rationale.

Standard information based on the published text of ISO 13849-2 (Validation). Event content is provided by the host. For authoritative guidance, consult the official standard body.