Challenging the necessity of citing EN ISO 12100

“The client wants me to reference EN ISO 12100 compliance, but they have no idea what this means…”

In the world of machinery safety and compliance, EN ISO 12100 is a fundamental standard. However, it’s not uncommon for clients, or more often their customers, to request compliance with this standard without understanding what it is they are asking. This misunderstanding can lead to unnecessary work and confusion, as was recently highlighted in a case where we provided compliance support for a robot end-effector.

At Knox Thomas, we specialise in ensuring machinery complies with relevant legislation and safety standards. Recently, we were tasked with ensuring a robot end-effector adhered to The Supply of Machinery (Safety) Regulation 2008. In this process, we identified EN ISO 10218-2 as the key standard for conducting our compliance assessment. This C-type standard, specific to robots and robotic systems, allowed us to identify and mitigate potential hazards effectively.

After completing our work…

The end customer requested that we meet the requirements of BS EN ISO 12100-Part 1&2: 2003. Herein lay the first issue: they were referencing a withdrawn edition of the standard; the current revision is EN ISO 12100:2010. Moreover, they were asking for “compliance to it,” a curious demand considering EN ISO 12100 doesn’t contain specific technical requirements for machinery. Instead, it’s an A-type standard that provides a framework for risk assessment, serving as a foundation for all C-type standards.

EN ISO 12100 outlines a methodology for conducting risk assessments and implementing risk reduction measures. It does not specify any technical control measures to be applied to machinery. The C-type standard, EN ISO 10218-2, which we applied to the end-effector design, addresses significant hazards for robot systems as a result of the hazard identification and risk assessment described in ISO 12100. The technical requirements of EN ISO 10218-2 are derived from the iterative process of applying risk reduction measures in accordance with EN ISO 12100 which is inherent within the applied standard.

Presumption of Conformity…

Thus, by using EN ISO 10218-2, we effectively met the aims of EN ISO 12100, and as the particular standard is “designated”/”harmonized” it provides a legal “presumption of conformity” to The Supply of Machinery (Safety) Regulation 2008. We presented this rationale to the end customer, explaining that the use of the appropriate C-type standard inherently satisfies the requirements of the A-type standard. Fortunately, the customer accepted our explanation and did not request further unnecessary actions.

This scenario is a prime example of how a lack of understanding regarding standards and compliance can lead to redundant work and inefficiencies. It’s crucial for clients and their customers to grasp the purpose and scope of the standards they reference.

In summary…

While EN ISO 12100 is essential for understanding and conducting risk assessments, it is not a standard providing specific technical requirements that can be “complied with”. The application of appropriate C-type standards, derived from the principles of EN ISO 12100, ensures comprehensive safety and compliance. Educating clients and their customers about the correct application of these standards can save time, resources, and prevent unnecessary work. At Knox Thomas, we are committed to providing clarity and ensuring that all machinery meets the highest safety and compliance standards efficiently and effectively.

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