Compliance 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 imply both due challenges and chances. 

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 imply both due challenges and chances. 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 assess the conformity versus those: efficiently, risk based, in possession of our wide portfolio of qualifications and professional instruments, meeting this complex demand.

 

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:

The compliance with the requirements (CE-marking) of market placement of robots, robot systems and components is mandatory. Without this the distribution is prohibited and the users cannot install and put them into operation.

• 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 obtanied.

• 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.

 

Affected:

• Manufacturers of robots, robot systems and components

• Distributors or importers of robots, robot systems and components

• Integrators (installers)

• Users (operators)

• Market surveillance and labor safety authorities

 

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

 

Services in key words:

• Authorised representation (takeover of manufacturers’ responsibility)

• Complete CE marking procedure

• Tests according to relevant standards

• Risk assessment

• Validation of safety functions (SRP/CS)

• Technical-legal consultancy and expert services (requirements, procedures, etc.)

• Theoretical and practical trainings (CE-marking of robots, robot systems, legal and technical requirements, duties of manufacturers and operators, safety technology, health and lab safety, cybersecurity, etc.)

• Review of the conformity assessment documentation

• Certificate of Conformity, EC Type Certification

• Compliance and safety checks during takeover and installation, supplier management

• Pre-commissioning, periodic and non-routine laboratory safety inspection

 

Main legislation: Main standards:
• 2006/42/EK (MD) • EN ISO 10218-1
• 2014/30/EU (EMC) • EN ISO 10218-2
• 2014/35/EU (LVD) • ISO/TS 15066
• 2011/65/EU (RoHS) • EN ISO 3691-4
• 2014/53/EU (RED) • EN 1175-1
• 2017/745/EU (MDR) • EN 60204-1
• 2017/745/EU (MDR) • EN ISO 13489-1
  • IEC/EN 60601-1
  • EN ISO 13482

 

• INDUSTRIAL ROBOT • INDUSTRIAL COLLABORATIVE ROBOT • MEDICAL ROBOT • HOUSEHOLD AND PERSONAL ASSISTANCE ROBOT • AUTOMATED GUIDED VEHICLE - NEW GENERATION OF AGV • INDUSTRIAL ROBOT SYSTEM • LOGISTICS ROBOT SYSTEM

 

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