This point has a direct effect on test benches. Test benches grow over 15 to 20 years through continuous extensions. Article 3(16) defines the term for the first time in EU law:
“‘substantial modification’ means a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new hazard, or by increasing an existing risk, which requires: (a) the addition of guards or protective devices to that machinery or related product the processing of which necessitates the modification of the existing safety control system; or (b) the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product”[9].
Thus the definition has 3 stages. The manufacturer did not foresee the modification. The modification causes a new hazard or increases a risk that is already there. As a result, one of the 2 measures in point (a) or (b) is necessary. Recital 26 describes the third stage in general terms with the criterion “when new significant protective measures are required”[1]. For the examination, the text of Article 3(16) is decisive.
A direct effect on test benches: purely digital modifications too can be substantial. Examples are a changed safety application in the safety controller or an additional interface for remote access. Such a modification is substantial only if it affects safety and makes a measure in point (a) or (b) necessary. An example for point (a): it is necessary to connect an additional protective device to the safety control system of the machine.
Role of manufacturer after a substantial modification
Article 18 gives the result. The second half of the sentence has a direct effect on plant construction:
A person who makes a substantial modification is a manufacturer and has the obligations of the manufacturer for the machinery “or, if the substantial modification has an impact on the safety of only machinery or a related product that is part of an assembly of machinery, for that affected machinery or related product, as demonstrated in the risk assessment”[9].
Thus it is possible to limit the obligations of the manufacturer to the affected part machine. The condition is that the risk assessment shows the limit of the effect. An example: on a heat pump test bench in operation, the operator replaces only the module for media conditioning. Then the operator does not necessarily have to assess the full plant again. Without the documented evidence, the full obligation of the manufacturer applies to the full assembly.
Sequence of checks for each conversion
From the definition comes a sequence of checks for each conversion:
- Did the manufacturer foresee or plan the modification? Examples: documented variants, defined extension stages and released parameter ranges in the instructions for use. If the manufacturer foresaw the modification, there is no substantial modification.
- Does a new hazard occur, or does a risk that is already there increase?
- As a result, is a measure in point (a) or (b) necessary? Point (a): an additional guard or protective device, and its connection changes the safety control system. Point (b): additional protective measures for stability or mechanical strength[9].
A substantial modification exists only if the answer to question 1 is no and the answers to questions 2 and 3 are yes.
Article 3(18) tells who is a manufacturer. It also applies explicitly to a person who “puts those products into service for its own use”[9]. Thus a company that builds a test bench for its own laboratory is a manufacturer in the legal sense. It has the obligations for risk assessment, technical documentation, conformity assessment, declaration of conformity, CE marking and instructions for use.