Functional Safety Certification for Pharmacy Automation Robots: ISO 14118 Explained

Date
2027-04-02
Location
Online
Host
Zach L

About this event

An Executive Briefing for Manufacturing Engineers pursuing functional safety certification. A live 30-minute executive briefing on ISO 14118 (Prevention of Unexpected Start-Up) for pharmacy automation robots, built for manufacturing engineers pursuing functional safety certification. What We'll Cover: What ISO 14118 (Prevention of Unexpected Start-Up) requires and how its scope applies to pharmacy automation robots Mapping ISO 14118 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 manufacturing engineers preparing for assessment Related topics: ISO 14118 · Pharmacy Automation Robots · functional safety cer

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About ISO 14118 (Prevention of Unexpected Start-Up)

This event covers the compliance, engineering, and verification requirements defined by ISO 14118.

EN ISO 14118 specifies measures preventing unexpected machine start-up during human intervention — the foundation of safe maintenance, cleaning, and jam clearing — via energy isolation, dissipation, and start-command control.

What it regulates

Isolation and energy dissipation devices (electrical, pneumatic, hydraulic, gravitational, stored energy), lockout capability, and design measures preventing start commands from reaching actuators during intervention.

Who must comply

Machine designers defining maintenance access; plant operators implementing lockout/tagout consistent with the machine's provisions (OSHA 1910.147 in the US context).

Key requirements of ISO 14118

  • Hierarchy: isolation and dissipation where reasonably practicable for interventions
  • Requirements for disconnectors, valves, and locking means
  • Control-system measures (safe standstill monitoring, key transfer) where full isolation is disproportionate for short frequent tasks
  • Verification of energy states before access

Key concepts: ISO 14118

Energy isolation
Physical separation from all energy sources, lockable in the safe position.
Safe standstill via control system
Monitored standstill (as an SRP/CS function) permitted for frequent short interventions per risk assessment.
Stored energy dissipation
Bleeding accumulators, discharging capacitors, restraining gravity loads before access.
Trapped key systems
Mechanical key-transfer schemes enforcing sequence between isolation and access.

Frequently asked questions: ISO 14118

How does ISO 14118 relate to LOTO regulations?

ISO 14118 governs what the machine must provide (isolation points, lockability, dissipation); operational lockout procedures like OSHA's 1910.147 govern how personnel use them — both must fit together.

Is control-system-based prevention of start-up acceptable instead of lockout?

For frequent, short, low-complexity interventions the risk assessment may justify monitored safety functions (safe standstill, enabling devices) at appropriate PL; for maintenance-type work full isolation with lockout remains the expected measure.

Standard information based on the published text of ISO 14118 (Prevention of Unexpected Start-Up). Event content is provided by the host. For authoritative guidance, consult the official standard body.