ISO 12100 is the international standard that sets out how to assess and reduce risk when designing machinery. It does not list requirements for a specific machine. It gives the method by which a maker identifies hazards, estimates risk and reduces it, and the result is a documented risk assessment.
For an importer, the risk assessment is the strongest evidence that a machine was designed with safety in mind. If a supplier cannot show one, treat the CE or conformity claims with caution.
What the standard asks for
The standard, titled Safety of machinery: general principles for design, risk assessment and risk reduction, describes an iterative process. The maker defines the machine's limits, including intended use and reasonably foreseeable misuse, identifies hazards, estimates and evaluates the risk, and reduces it until it is acceptable.
Estimating risk usually considers the severity of harm and the probability that it occurs, including exposure and the chance of avoiding it. The assessment is repeated whenever the design changes.
The three-step method
ISO 12100 sets an order of preference for reducing risk. A maker should not jump to the last step.
- First, inherently safe design: remove the hazard or reduce it by the way the machine is built.
- Second, safeguarding and complementary protective measures: guards, interlocks, light curtains and emergency stops.
- Third, information for use: warnings, instructions and training, which cover only the risk that remains.
How it connects to CE and local rules
In the EU, the risk assessment is part of the technical file and supports the declaration of conformity. See CE marking for machinery and the technical file. Other markets draw on the same standard in their own rules, and ISO 12100 is a type A standard, which underpins more specific standards for machine types.
For certain machines, more specific standards apply, for example for control system safety or particular machine families. Ask the supplier which standards they used and to show you the list. A related standard on safety-related parts of control systems is often cited for guards, interlocks and emergency stops, so ask whether the controls were assessed to it.
How to review a supplier's risk assessment
Do not just accept a file. Read it against the machine, and check three things. Does it cover all the life phases, including setting, cleaning and maintenance, not only normal running? Do the safeguards listed match what is physically on the machine? Is it signed and dated for the current design?
On a power press, for example, the guarding and two-hand controls shown in the paperwork must be on the actual unit. Read press safety guards for export. Check at the factory acceptance test, not after arrival. Test the emergency stop, try to reach moving parts with the guards closed, and note anything the paperwork promises that the machine lacks. A gap found in the factory costs a visit; the same gap found at your site costs a stoppage.
Next step
Ask for the risk assessment before you sign the order, and make it part of the delivery documents. We audit the factory, check documents against the machine and supervise testing. Book a free sourcing review. For legal duties in your market, confirm with your regulator or compliance adviser.