NAMUR's AK 4.5.1 “Machinery safety in the pharmaceutical industry” has published an update of its position paper “Pumps as 'complete' machines according to EC Machinery Directive 2006/42/EC”. The entire paper is available for download free of charge.
According to the EC Machinery Directive 2006/42/EC, which is attached to the position paper, the manufacturer defines the limit of the machine and the intended use. For standardised pumps, the manufacturer of the pump must consider the intended use in his risk assessment.
During design, the manufacturer specifies what else must or can be added to the pump to be within its intended use. Examples of completion specifications are:
- Drive
- Coupling system
- Contact protection
- Safety devices, etc
- Installation conditions, such as installation, nozzle loads, earthing, etc.
Experience of the working group members taken into account
Within the manufacturer's conformity assessment, the technical specifications still to be fulfilled are described in detail with regard to the attachments or boundary conditions still to be considered. The manufacturer has checked and presented generic operating conditions. He offers pumps for the defined and described operating conditions.
If operator requirements do not correspond to the offer descriptions, the operator must contact the manufacturer during procurement so that it can be clarified together whether the intended use is covered by the defined application limits of the manufacturer or, if necessary, supplementary measures can be taken into account before commissioning in order to also cover this case with the validity of the declaration of conformity.
The AK-POSITION reflects the experiences of the members of AK 4.5.1 and has been agreed within the framework of the working group. It does not have the consensus level of a NAMUR recommendation or a NAMUR worksheet. With an AK-POSITION, the working group has the opportunity to make its own experiences available to interested readers in a timely manner.
