Glossary · Safety standards
ISO 12100
Also known as: ISO 12100:2010, EN ISO 12100
German: ISO 12100
ISO 12100 is the international standard for the general principles of machinery design, risk assessment and risk reduction. As the type-A standard of machinery safety, it defines basic terms such as hazard, risk and safeguard, and sets out the iterative process of risk assessment and the three-step method of risk reduction.
- Standards
- Technical documentation
In one sentence
ISO 12100 is the type-A machinery standard for risk assessment and risk reduction, including the three-step method and basic safety terms.
Example
Before designing the guards of a new integrated packaging line, the team determines the machine limits, identifies hazards per lifecycle phase, estimates and evaluates each risk, and then applies the three-step method, all following ISO 12100.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
- Documenting foreseeable misuse without making it an optionHow do instructions describe reasonably foreseeable misuse without presenting it as a way to use the product?UKDeutsch
- Operating modes in technical documentationWhy do operating modes change what the documentation of a machine has to say?UKDeutsch
- Task analysis across the documentation disciplinesWho uses task analysis, and which documents does it feed?UKDeutsch
How it applies
- Machine safety: The process runs from determining the machine limits through hazard identification, risk estimation and risk evaluation, to risk reduction, and repeats until the remaining risk is adequately reduced.
- Three-step method: Inherently safe design first, then safeguarding and complementary protective measures, then information for use. Each step is used only for the risk the previous steps could not reduce.
- Standards hierarchy: Type-B and type-C standards build on ISO 12100. Where a type-C standard deviates from it, the type-C standard takes precedence for machines within its scope.
- Technical documentation: The standard lists what the risk assessment documentation should contain: the machine, limits, hazards identified, information used, risk reduction objectives, measures, residual risks and the result. This is the backbone of the technical file.
ISO 12100 vs. AI risk planning
ISO 12100 addresses the hazards of the machine. For AI functions in machinery, AI risk planning under the AI Act adds risks such as data quality and model behavior. The two should share one hazard list, so that the three-step method still governs how AI-related risks are reduced.