EUROPEAN CONFORMITY of
robots and robot systems
The human-centered safety-, functional-, collaboration- and cybersecurity conformity assessment of robots and robot systems is a positive constraint: the automation of industrial manufacturing and logistics systems, the introduction of robots, the strive for robotization in households and in healthcare applications implies both due challenges and chances.
KEY words
Authorised representation (takeover of manufacturers’ responsibility) • Compliance and safety checks during takeover and installation, supplier management • Certificate of Conformity, EC Type Certification • Theoretical and practical trainings, consultancy and expert services • Risk assessment • Tests according to relevant standards • Complete CE marking procedure
Main standards
EN ISO 10218-1• EN ISO 10218-2 • ISO/TS 15066 • EN ISO 3691-4 • EN 1175-1 • EN 60204-1 • EN ISO 13489-1 • IEC/EN 60601-1 • EN ISO 13482
Main legislation
2006/42/EK (MD) • 2014/30/EU (EMC) • 2014/35/EU (LVD) • 2011/65/EU (RoHS) • 2014/53/EU (RED) • 2017/745/EU (MDR) • OHS legislations
CONFORMITY
The relevant authorities, the regulators, the standardization organizations and the Testing, Inspection and Certification(TIC) professionals have been defining many usability and safety requirements. Our experts perform the conformity assessments efficiently, with a risk-based approach and supported by our extensive range of measuring instruments and qualifications. You can focus on creating and using your robot systems while we take care of their conformity and safety and takeover your manufacturer’s responsibility as your representative.
CHALLENGES IN THE EU MARKET
• To put robots and robot systems on the market, you need to comply with CE marking requirements. Without this the distribution is prohibited and your customers will not be able to install them and put them into operation.
• Many industrial robots are so called „partially completed machines”, the operation of which can only be started after the CE marking of a completed robot system is obtained.
• Following the integration of robots and other equipment and components a new complex machine, a robot system is created, which is also subject of CE marking.
• In certain cases the involvement of Notified Bodies (NoBo's) is mandatory to the CE marking, in other cases the manufacturer can act on their own.
• The manufacturer of robots and robot systems must meet and certify the mandated safety requirements to be able to put them into operation.
• The operator must perform periodical safety inspections during the operation of the industrial robot systems.
• Modifications of the robot systems typically require a repeated performance of the CE marking procedure, moreover, in order to continue with the operation, a health and safety review is needed.
Objectives you can reach with our services:
Proper placing of robotic products on the market • Successful and compliant commissioning of robot systems • Safe operation of robot systems • Prepared and competent personnel • Mitigation of business and safety related risks
AFFECTED
• Manufacturers of robots, robot systems and components
• Distributors or importers of robots, robot systems and components
• Integrators (installers)
• Users (operators)
• Market surveillance and laboratory safety authorities
