ISO 12100
ISO 12100 is the foundational "Type-A" standard that dictates the general principles for designing safe machinery. For North American exporters, it is the bible of compliance. While the Machinery Directive tells you what to achieve (safety), ISO 12100 tells you how to achieve it. Following this standard creates a "presumption of conformity," meaning authorities assume your Risk Assessment methodology is valid.
The standard mandates a strict iterative process. First, you must determine the machinery's limits (intended use and misuse). Next, you identify hazards and estimate risks. Crucially, ISO 12100 enforces a "three-step method" for Risk Mitigation Measures: you must first attempt to eliminate risks through inherently safe design. If that fails, you apply safeguarding (like light curtains). Only as a last resort can you rely on Information for Use (warnings/labels).
Failing to follow this hierarchy—for example, using a warning label when a guard was possible—is a primary reason for Technical File rejection by Trading Standards.
