ISO 11161:2007/Amd 1:2010

Overview

ISO 11161:2007/Amd 1:2010 is an important amendment to the international standard focused on the safety of machinery in integrated manufacturing systems (IMS). This amendment aims to ensure compliance with the European New Approach Directive 2006/42/EC on machinery safety, replacing the previous directive without transitional provisions. It makes necessary updates and minor technical changes that align the existing standard ISO 11161:2007 with new regional regulations.

Prepared by the ISO Technical Committee ISO/TC 199, the amendment emphasizes harmonization with key safety principles and risk assessment guidelines, reinforcing safe design and operation in complex manufacturing environments.

Key Topics

• Integrated Manufacturing Systems (IMS) Safety: Establishes basic safety requirements for machinery operating as part of integrated production lines, focusing on hazard control and risk reduction.
• Alignment with European Legislation: Modifications ensure compliance with essential requirements of Directive 2006/42/EC, key for manufacturers and regulatory bodies in Europe.
• Updated Normative References:
  • ISO 14121 replaced by ISO 14121-1:2007 (Risk assessment principles).
  • Addition of ISO 12100-2:2003/Amd.1:2009 (Basic concepts and technical design principles).
• Technical Clarifications and Corrections:
  • Revised task zone safety parameters to reflect correct annex references.
  • Improved descriptions for operating modes and risk reduction measures.
  • Updates to graphical illustrations and user instructions for clarity.
• Risk Assessment and Control: Enhances principles related to machine safety by incorporating latest risk evaluation methods, per ISO risk management standards.
• Machine Marking and Documentation: Specifies requirements for labeling IMS components according to ISO 12100-2 standards, aiding traceability and compliance.

Applications

ISO 11161:2007/Amd 1 applies to a range of industrial integrated manufacturing systems, including:

• Automated production lines combining multiple machines and processes.
• Systems where machinery works collaboratively in a continuous or sequential manufacturing workflow.
• Safety assessments and design of modern manufacturing plants implementing automation and robotic elements.
• Regulatory compliance verification for manufacturers and safety engineers in EU markets.
• Risk management practices to minimize hazards related to machine integration, such as inadvertent access to dangerous zones or control system failures.

Implementing this amendment helps organizations safeguard operators, maintain operational efficiency, and fulfill legal safety requirements. It is relevant for designers, safety consultants, machine builders, and compliance auditors.

Related Standards

• ISO 14121-1:2007 – Safety of machinery – Risk assessment, Part 1
  Provides principles for systematic hazard identification and risk evaluation essential for machine safety.

• ISO 12100-2:2003/Amd.1:2009 – Safety of machinery – Basic concepts and design principles
  Details technical principles for designing safe machinery, supporting the requirements of ISO 11161 amendment.

• IEC 60204-1:2005 – Safety of machinery – Electrical equipment of machines
  Outlines electrical safety requirements referenced for integrated systems.

• UNECE Recommendation L
  Framework for international machinery safety harmonization adopted by ISO standards.

Adherence to ISO 11161:2007/Amd 1:2010 alongside these standards ensures organizations implement comprehensive safety strategies aligned to international best practices, particularly in increasingly complex manufacturing settings.

Keywords: ISO 11161 amendment, integrated manufacturing systems safety, machinery safety standards, ISO/TC 199, risk assessment ISO 14121-1, European machinery directive 2006/42/EC compliance, industrial automation safety, machine safety design, ISO 12100-2, IEC 60204-1