Challenging the Necessity of Citing EN ISO 12100
What does it really mean to reference EN ISO 12100…
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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.
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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.
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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 Herein lay the first issue: they were referencing a withdrawn edition of the standard; the current revision is EN ISO 12100:2010.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.
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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.
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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.
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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.
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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.
As a bare minimum 12100 needs to be done to ascertain any other outlying risks, you can’t simply omit it from the RA process by applying a C standard to determine compliance. Almost all C type standards ask for a RA to be completed and 12100 is the standard used, you would be hard pressed in a court explaining why you didn’t use what is a industry and well proven standard such as 12100.
Managing Director and founder at Sheppard Innovations Ltd
4 个月This is very insightful I will have to take a deeper look in to this. Thank you for sharing.
Senior Machinery CE Compliance Engineer and Podcast Host
4 个月The A-Tyoe standard EN ISO 12100, is the starting point for any machine based risk assessment. Clause 4 is a really good starting point and every engineer should not only be aware of it, but understand it, and know it like the back of their own hand. If they did it would save a lot of problems further down the line. I see a lot of requests for things that are out of date, not relevant or just plainly wrong, it where a little knowledge can be dangerous. If you want to help customers understand about the difference between A,B and C-Tyoe standards, then here’s a podcast episode that’ll save you some time. https://shows.acast.com/645951b1f6507e00111e7501/64b06f50738d4000115af1d5
Machinery Safety / Functional Safety Specialist
4 个月Using a C-standard does not allow you to ignore the need to do a Risk Assessment, since the C-standard might not capture all application-specific hazards - after all how can the technical committees that maintain C-standards foresee how your version of "Machine X" might be different. Although ISO 10218-2 has a pretty comprehensive Annex G verification checklist, I suggest a Risk Assessment is necessary particularly for end-effectors and tool-changer systems (for which there are actually a separate TR ISO 20218-1 and C-standard ISO 11593). As Harry, Martijn and Les all state, any decent C-standard (including ISO 10218-2) calls for the need to do a Risk Assessment and ISO 12100:2010 is the go to standard for this - so I do not think it is a redundant request at all. The user will rightly want to know that the relevant technical requirements of ISO 10218-2 are satisfied, and that a suitable and sufficient risk assessment has been done to address all application-specific hazards. The tooling I was responsible for in my last company had complete ISO 12100:2010 risk assessments with many hazards associated with pneumatically actuated clamps, suction cups, Class 3R lasers, drills, glue dispensing etc.
MD and Principal Consultant at Astute Machinery Consultants Ltd
4 个月We would always do a 12100 RA irrespective of any type C standard - its about due dilligence and a comprehensive compliant hazard analysis of the equipment... I wouldn't want to be stood in front of a judge asking my why I didn't do a EN ISO 12100 compliant risk assessment on a machine if things had gone wrong when the MD require its - sorry...