Functional Safety Certification for Hospital Logistics Robots: ISO 13849-1 Explained

Date
2026-08-17
Location
Online
Host
Zach L

About this event

A Verification and Validation Clinic for Regulatory Affairs Specialists pursuing functional safety certification. A live 30-minute verification and validation clinic on ISO 13849-1 (Safety-Related Parts of Control Systems) for hospital logistics robots, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What ISO 13849-1 (Safety-Related Parts of Control Systems) requires and how its scope applies to hospital logistics robots Mapping ISO 13849-1 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of hospital logistics robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for regulatory affairs specialists preparing for assessment Related top

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About ISO 13849-1 (Safety-Related Parts of Control Systems)

This event covers the compliance, engineering, and verification requirements defined by ISO 13849-1.

EN ISO 13849-1 specifies how to design and validate safety-related parts of control systems (SRP/CS) for machinery, technology-neutral (electrical, hydraulic, pneumatic, mechanical), using Performance Levels PL a-e to express required and achieved risk reduction.

What it regulates

Determination of required Performance Level (PLr) from the risk graph, realization via designated architecture Categories B to 4, and calculation of achieved PL from MTTFd, diagnostic coverage, and common-cause measures.

Who must comply

Machine builders and integrators designing interlocks, e-stops, safe speed, light-curtain muting and similar functions; component suppliers publishing PL/Category data for safety devices.

Key requirements of ISO 13849-1

  • Risk graph (severity S, frequency/exposure F, possibility of avoidance P) assigning PLr a-e
  • Categories B,1,2,3,4 as designated architectures with defined fault behavior
  • Quantification: MTTFd bands, DCavg bands, CCF score of at least 65 points
  • Software requirements for SRESW and SRASW proportional to PL
  • Combination and validation of subsystems; relationship to SIL via mapping table

Key concepts: ISO 13849-1

Performance Level (PL a-e)
Discrete levels of average probability of dangerous failure per hour for a safety function, PL e the highest.
Category
The structural architecture (single channel, tested single channel, redundant, redundant with high diagnostics) underpinning a PL claim.
CCF score
Checklist-based (Annex F) demonstration, minimum 65 points, that redundant channels resist common-cause failure.
DCavg
Averaged diagnostic coverage across the function's parts.
MTTFd
Mean time to dangerous failure of each channel, banded low/medium/high per channel.

Frequently asked questions: ISO 13849-1

PL or SIL — which applies to machinery?

Both ISO 13849-1 (PL) and IEC 62061 (SIL) are harmonized for machinery control safety; teams choose one framework per function. 13849 spans mixed technologies; 62061 suits complex electronic architectures. Mapping: PL c roughly SIL 1, PL d roughly SIL 2, PL e SIL 3.

What does PLr depend on?

The risk graph parameters at the hazard before the safety function: severity of possible injury (S1/S2), frequency or duration of exposure (F1/F2), and possibility of avoiding the hazard (P1/P2).

Does Category 3 automatically give PL d?

No. Category sets the architecture, but achieved PL also depends on MTTFd, DCavg, and CCF; a Category 3 structure with poor component reliability or weak diagnostics can fall below PL d.

Standard information based on the published text of ISO 13849-1 (Safety-Related Parts of Control Systems). Event content is provided by the host. For authoritative guidance, consult the official standard body.