Functional Safety Certification for Pharmacy Automation Robots: Performance Level Explained

Date
2027-01-08
Location
Online
Host
Zach L

About this event

A Compliance Clinic for Commissioning Engineers pursuing functional safety certification. A live 30-minute compliance clinic on Performance Level (PL) Calculation with SISTEMA for pharmacy automation robots, built for commissioning engineers pursuing functional safety certification. What We'll Cover: What Performance Level (PL) Calculation with SISTEMA requires and how its scope applies to pharmacy automation robots Mapping Performance Level 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 commissioning engineers preparing for assessment Related topics: Performance Level · Pharmacy Automation Robots · func

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About Performance Level (PL) Calculation with SISTEMA

This event covers the compliance, engineering, and verification requirements defined by Performance Level (PL) Calculation with SISTEMA.

SISTEMA is the IFA's free software tool implementing ISO 13849-1 mathematics: modeling safety functions as subsystem chains and computing achieved PL from Category, MTTFd, DCavg and CCF inputs, replacing error-prone manual lookup of Annex K tables.

What it regulates

Practical PL verification workflow: structuring functions into input-logic-output subsystems, importing manufacturer component libraries, entering mission time and diagnostic data, and generating the documentation for the technical file.

Who must comply

Machine safety engineers verifying PLr achievement; component suppliers publishing SISTEMA libraries for their devices.

Key requirements of Performance Level (PL) Calculation with SISTEMA

  • Project structure: safety function, subsystems, channels/blocks, elements
  • Component libraries with manufacturer PL/B10d/MTTFd data
  • Automatic computation of channel MTTFd (parts-count), DCavg weighting, and PL with PFHd
  • Report generation for validation evidence

Key concepts: Performance Level (PL) Calculation with SISTEMA

B10d
For electromechanical parts, the cycle count at which 10 percent fail dangerously — converted to MTTFd via actual operation rate (nop).
nop
Annual operation count derived from usage assumptions (days, hours, cycle time) driving wear-based reliability.
Parts-count method
Summation of element failure contributions to a channel's MTTFd, capped at 100 years per channel.
PFHd
The computed average probability of dangerous failure per hour mapped to the PL bands.

Frequently asked questions: Performance Level (PL) Calculation with SISTEMA

Is a SISTEMA report sufficient validation?

It evidences the quantitative leg. Full validation per ISO 13849-2 still needs functional and fault-injection testing, software verification, and confirmation of CCF measures and application assumptions.

Why does SISTEMA cap MTTFd at 100 years?

ISO 13849-1 caps the per-channel MTTFd credit at 100 years (2015 edition) to keep claims within the method's calibration; better components then improve robustness margin, not the computed PL.

Standard information based on the published text of Performance Level (PL) Calculation with SISTEMA. Event content is provided by the host. For authoritative guidance, consult the official standard body.