Functional Safety Certification for Pharmacy Automation Robots: ISO 20607 Explained

Date
2026-12-11
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 20607 (Instruction Handbooks for Machinery) for pharmacy automation robots, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What ISO 20607 (Instruction Handbooks for Machinery) requires and how its scope applies to pharmacy automation robots Mapping ISO 20607 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 regulatory affairs specialists preparing for assessment Related topics: ISO 20

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About ISO 20607 (Instruction Handbooks for Machinery)

This event covers the compliance, engineering, and verification requirements defined by ISO 20607.

EN ISO 20607 specifies content and drafting principles for machinery instruction handbooks, giving structure to the 'information for use' step of ISO 12100 risk reduction and the Machinery Regulation's documentation EHSRs.

What it regulates

Handbook structure, safety information placement, residual-risk communication, required lifecycle coverage (transport, installation, operation, maintenance, dismantling), and readability principles.

Who must comply

Machinery manufacturers preparing CE technical documentation; technical writers producing user information as part of conformity.

Key requirements of ISO 20607

  • Minimum content per lifecycle phase
  • Safety chapter and residual-risk warnings aligned with the risk assessment
  • Presentation rules: language, structure, warnings format consistent with ISO 3864/ANSI Z535 principles
  • Relationship between handbook and markings/signals on the machine

Key concepts: ISO 20607

Information for use
The third step of risk reduction — instructions and warnings covering risks that design and safeguarding could not eliminate.
Lifecycle coverage
The handbook must serve every foreseeable phase, not only normal operation.
Residual risk disclosure
Explicit, task-linked warnings tracing back to the risk assessment.

Frequently asked questions: ISO 20607

Do digital-only manuals satisfy the requirements?

Under the new Machinery Regulation 2023/1230, digital instructions are permitted with conditions, including providing paper on request and ensuring availability for the machine's lifetime; the handbook content itself should follow ISO 20607.

Can warnings replace safeguarding?

No — ISO 12100's hierarchy forbids substituting information for feasible design or safeguarding measures; the handbook addresses only what remains after those steps.

Standard information based on the published text of ISO 20607 (Instruction Handbooks for Machinery). Event content is provided by the host. For authoritative guidance, consult the official standard body.